Truenat Assays

Precision, Efficiency, and Reliability.

Designed to integrate flawlessly with the Truenat® platform, these assays unlock the full potential of real-time PCR diagnostics — anytime, anywhere.

Built on cutting-edge Taqman chemistry, these assays ensure superior sensitivity and specificity, making them a gold standard for decentralized testing.

KEY FEATURES AND ADVANTAGES

Lyophilized Reagents

Ready-to-usePCR reagents.

Advanced Technology

Taqman-based assays provide exceptional accuracy and reliability.

Biosafe

Requires minimal biosafety infrastructure, enabling safe field deployment.

Smart Chip

Embedded batch-specific data enhances result quantitation and traceability.

Contamination Control

Specially designed reaction port prevents contamination and evaporation.

Stable Reagents

Long shelf life, maintaining integrity for up to 2 years at 30°C.

Accurate

High primer sensitivity and specificity for precise disease detection.

Efficient

Specially designed reaction port prevents contamination and evaporation.

Rapid

Long shelf life, maintaining integrity for up to 2 years at 30°C.

Lyophilized Reagents

Ready-to-use PCR reagents.

Advanced Technology

Taqman-based assays provide exceptional accuracy and reliability.

Biosafe

Requires minimal biosafety infrastructure, enabling safe field deployment.

Smart Chip

Embedded batch-specific data enhances result quantitation and traceability.

Contamination Control

Specially designed reaction well prevents contamination and evaporation.

Stable Reagents

Long shelf life, maintaining integrity for up to 2 years at 30°C.

Accurate

High primer sensitivity and specificity for precise disease detection.

Efficient

Needs only 6µL of sample, ensuring minimal sample wastage.

Rapid

Sample-to-result in one hour (60 minutes), ensuring fast turnaround time.

Truenat® MTB

Truenat® MTB is a chip-based real-time PCR test for quantitative detection and diagnosis of Mycobacterium tuberculosis (MTB) in human pulmonary and EPTB specimens, aiding the diagnosis of tuberculosis.

Mycobacterium tuberculosis

WHO defines it as the bacterium causing tuberculosis (TB), primarily affecting the lungs but capable of affecting other body parts. A total of 1.25 million people died from TB in 2023 (including 161,000 people with HIV). TB is present in all countries and age groups, but is curable and preventable with timely diagnosis and treatment initiation.

Burden

Highest prevalence in:
  • India
  • Indonesia
  • China
  • Philippines
  • Pakistan
  • Nigeria
  • Bangladesh
  • South Africa
  • Democratic Republic of Congo
Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
  • High primer specificity and sensitivity ensure maximum accuracy
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry
Assay typeQuantitative detection
Total Assay Time60 minutes
Clinical SpecimenHuman pulmonary and EPTB specimen
Gene TargetnrdB gene which codes for Truenat® MTB ribonucleoside- diphosphate reductase large subunit
Internal ControlsInternal Process Control - Extraction Control
Sensitivity100%
Specificity100%
LOD100 CFU/mL
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat® MTB micro PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tip
Test pack size5T, 25, 50T
Test pack sizeCat No
5T601030005
25T601030025
50T601030050

Trueprep AUTO MTB Sample Pre-treatment Pack
Trueprep AUTO v2 universal cartridge-based Sample Prep Kit

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab Quattro

Truenat® MTB Plus

Truenat® MTB Plus is a chip-based Real Time PCR Test for semi-quantitative detection and diagnosis of Mycobacterium tuberculosis (MTB) in human pulmonary and EPTB specimens and aids in the diagnosis of infection with MTB.

Mycobacterium tuberculosis

WHO defines it as the bacterium causing tuberculosis (TB), primarily affecting the lungs but capable of affecting other body parts. While TB can affect all population, people with immunocompromised conditions such as HIV, diabetes, or children and pregnant women can fall sick with TB even with a low load of bacilli. A highly sensitive test that effectively detects the bacteria is crucial in disease response.

Burden

Highest prevalence in:
  • India
  • Indonesia
  • China
  • Philippines
  • Pakistan
  • Nigeria
  • Bangladesh
  • South Africa
  • Democratic Republic of Congo
Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
  • High primer specificity and sensitivity ensure maximum accuracy
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry
Assay typeSemi-quantitative detection
Total Assay Time60 minutes
Clinical SpecimenSputum / Non Sputum / EPTB
Gene Targetnrdz gene & IS6110 gene sequence
Internal ControlsInternal Process Control - Extraction Control
Sensitivity100%
Specificity100%
LOD29 cells/mL
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat MTB Plus micro PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tip
Test pack size-
5T601130005
25T601130025
50T601130050

Trueprep AUTO MTB Sample Pre-treatment Pack
Trueprep AUTO v2 Universal Cartridge Based Sample Prep Kit

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab Quattro

Truenat® MTB-RIF Dx

Truenat® MTB-RIF Dx is a chip-based real-time PCR Test for the detection of Rifampicin resistance in Mycobacterium tuberculosis in Truenat MTB/MTB Plus positive human specimens and aids in the diagnosis of MDR-TB. This test detects the presence of major mutations (SNPs) in the MTB genome that are known to cause resistance to rifampicin.

Mycobacterium tuberculosis

Rifampicin-resistant tuberculosis (RR-TB) occurs when Mycobacterium tuberculosis strains develop resistance to rifampicin, a critical first-line anti-TB drug. In 2020, nearly half a million individuals worldwide contracted RR-TB, underscoring its significant global health impact.

Burden

Highest prevalence in:

  • India
  • Indonesia
  • China
  • Philippines
  • Pakistan
  • Nigeria
  • Bangladesh
  • South Africa
Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
  • High primer specificity and sensitivity ensure maximum accuracy
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry followed by melt-curve assay
Assay typeQualitative detection
Total Assay Time60 minutes
Clinical SpecimenMTB positive human specimen
Gene TargetRRDR region of the rpoB gene
Internal ControlsInternal Process Control - Extraction Control
Sensitivity100%
Specificity96%
LOD200 cells/mL of Sputum
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat® MTB-RIF Dx micro-PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tip
Pack SizeCat. No.
5T601210005
20T601210020
25T601210025
50T601210050

Trueprep AUTO Universal Sample Pre-treatment Pack
Trueprep AUTO v2 Universal Cartridge-Based Sample Prep Kit

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab Quattro

Truenat® MTB-INH

Truenat® MTB-INH is a chip-based Real Time PCR test for detection of Isoniazid resistance in Mycobacterium tuberculosis (MTB) in Truenat MTB/MTB Plus positive human specimen and aids in the diagnosis of MDR-TB. This test detects the presence of major mutations (SNPs) in the MTB genome that are known to cause resistance to Isoniazid.

Mycobacterium tuberculosis

Isoniazid-resistant tuberculosis (INH-resistant TB) occurs when Mycobacterium tuberculosis develops resistance to isoniazid, a key drug used in the treatment of TB. Globally, INH resistance is a significant issue, with data showing that around 10-20% of multidrug-resistant TB (MDR-TB) cases also exhibit resistance to isoniazid. An effective drug susceptibility test for INH resistance is crucial for informed clinical decisions.

Burden

Highest prevalence in

  • India
  • Indonesia
  • China
  • Philippines
  • Pakistan
  • Nigeria
  • Bangladesh
  • South Africa
Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
  • High primer specificity and sensitivity ensure maximum accuracy
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry followed by melt-curve assay
Assay typeQualitative detection
Total Assay Time60 minutes
Clinical SpecimenMTB positive human specimen
Gene TargetinhA and katG genes of Mycobacterium tuberculosis genome
Internal ControlsInternal Process Control - Extraction Control
Sensitivity100%
Specificity96%
LOD494 cells/mL
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat® MTB-INH micro-PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tip
Pack SizeCat. No.
5T601360005
20T601360020
25T601360025
50T601360050

Trueprep AUTO Universal Sample Pre-treatment Pack
Trueprep AUTO v2 Universal Cartridge-Based Sample Prep Kit

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab Quattro

Truenat® Influenza A/B

Truenat® Influenza A/B is a chip-based Real Time Duplex PCR Test for semi-quantitative detection of Influenza A and Influenza B virus in human throat and nasal swab specimens and aids in differential diagnosis of infection with Influenza A and/or Influenza B virus.

Influenza A and B

A viral infection affecting the respiratory tract, there are around a billion cases of seasonal influenza annually, including 3–5 million cases of severe illness. With 290,000 to 650,000 respiratory deaths annually, ninety-nine percent of deaths are in children under 5 years of age, mostly in developing countries.

Burden

Global distribution with seasonal patterns:

  • Northern hemisphere: October to May
  • Southern hemisphere: April to September
  • Tropical regions: Year-round transmission
Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
  • High primer specificity and sensitivity ensure maximum accuracy
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry
Assay typeSemi-quantitative detection
Total Assay Time60 minutes
Clinical SpecimenHuman throat and nasal swab specimens
Gene TargetM gene of Influenza A and NSP gene of Influenza B genome
Internal ControlsInternal Process Control - Extraction Control
LOD810.15 copies/ml for Inf A, 755.21 copies/ml for Inf B
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat® Influenza A/B micro-PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tip
Pack SizeCat. No.
5T601200005
20T601200020
25T601200025
50T601200050

Trueprep AUTO Universal Sample Pre-treatment Pack
Trueprep AUTO v2 Universal Cartridge-Based Sample Prep Kit

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab Quattro

Truenat® H3N2/H1N1

Truenat® H3N2/H1N1 is a chip-based Real Time Duplex PCR Test for semi-quantitative detection of H3N2 and H1N1 virus in human throat and nasal swab specimens and aids in differential diagnosis of infections with H3N2 and/or H1N1 virus.

H3N2 and H1N1

H3N2 and H1N1 are subtypes of the Influenza A virus, both known to cause seasonal flu outbreaks. H3N2, a subtype of Influenza A, is known for its ability to evolve rapidly, making it a significant cause of flu-related illnesses, particularly in older adults and individuals with underlying health conditions. H1N1 caused the 2009 “swine flu” pandemic, resulting in an estimated 284,400 deaths worldwide.

Burden

Worldwide impact with particular severity in:

  • Densely populated urban areas
  • Regions with limited healthcare access
  • Areas with high elderly populations
Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
  • High primer specificity and sensitivity ensure maximum accuracy
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry
Assay typeSemi-quantitative detection
Total Assay Time70 minutes (samle to result)
Clinical SpecimenOropharyngeal/ Nasopharyngeal swab
Gene TargetConserved sequences of swine influenza A virus (swInfA) nucleocapsid gene, the H1N1 swine influenza A virus (swH1) hemagglutinin gene
Internal ControlsHuman RNase P gene - full process internal positive control (IPC) for swab collection,
Sensitivity100%
Specificity99%
LOD873.02 copies/mL
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat® H3N2/H1N1 micro-PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tip
Pack SizeCat. No.
5T601310005
20T601310020
25T601310025
50T601310050

Trueprep AUTO Universal Sample Pre-treatment Pack
Trueprep AUTO v2 Universal Cartridge-Based Sample Prep Kit

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab Quattro

Truenat® COVID-19

Truenat® COVID-19 is a chip-based Real Time Duplex PCR Test for semi-quantitative detection of SARS CoV-2 RNA in human oropharyngeal and nasopharyngeal swab specimen and aids in detection and confirmation of SARS CoV-2 infection and diagnosis of COVID-19. The test detects the E and Orf1a genes of the virus.

COVID-19

COVID-19, caused by the SARS-CoV-2 virus, primarily affects the respiratory system. It emerged in late 2019 and rapidly evolved into a global pandemic causing more than 6.88 million deaths worldwide.

Burden

Global pandemic affecting all countries, with particular impact on:

  • Dense urban areas
  • Countries with aging populations
  • Regions with limited healthcare infrastructure
  • Areas with high rates of comorbidities

 

Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
  • High primer specificity and sensitivity ensure maximum accuracy
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry
Assay typeSemi-quantitative detection
Total Assay Time60 minutes
Clinical SpecimenHuman oropharyngeal and nasopharyngeal swab specimen
Gene TargetE and Orf1a gene
Internal ControlsInternal Process Control - Extraction Control
Sensitivity100%
Specificity100%
LODOrf1a: 480 genome copies/mL, E gene: 487 genome copies/mL
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat® Inf A,B/COVID-19 micro PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tip
Pack SizeCat. No.
5T601430005
20T601430020
25T601430025
50T601430050

Trueprep AUTO Universal Sample Pre-treatment Pack
Trueprep AUTO v2 Universal Cartridge-Based Sample Prep Kit

Trueprep AUTO v2

Truelab Uno Dx/Truelab Duo/Truelab Quattro

Truenat® Inf A,B/COVID-19

Truenat® Inf A, B/COVID-19 is a chip-based Real Time Duplex PCR Test for semi-quantitative detection of InfluenzaA,B and COVID-19 in human oropharyngeal and nasopharyngeal swab specimen and aids in the differenetial diagnosis of infection with Influenza A,B and COVID-19 virus.

Influenza A and B

WHO defines these as viral infections affecting the respiratory tract. Influenza A can infect humans and animals, while Influenza B primarily affects humans.

Burden

Burden: Global distribution with seasonal patterns:

  • Northern hemisphere: October to May
  • Southern hemisphere: April to September
  • Tropical regions: Year-round transmission
Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
  • High primer specificity and sensitivity ensure maximum accuracy
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry
Assay typeSemi-quantitative detection
Total Assay Time60 minutes
Clinical SpecimenHuman oropharyngeal and nasopharyngeal swab specimens
Gene TargetOrf1a gene and RdRP gene for COVID-19. For Influenza A it is gene coding for matrix protein and for Influenza B it is gene coding for nonstructural protein.
Internal ControlsInternal Process Control - Extraction Control
Sensitivity100%
Specificity100%
LODLoD for Inf A, Inf B and COVID-19 was estimated to be 887.42, 786.20 and 493.66 genome copies/ml respectively
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  • Truenat® Inf A,B/COVID-19 micro PCR chip
  • Microtube with freeze dried RT PCR reagents
  • DNase & RNase free pipette tip
Pack SizeCat. No.
5T601720005
20T601720020
25T601720025
50T601720050

Trueprep AUTO Universal Sample Pre-treatment Pack
Trueprep AUTO Transport Medium for Swab Specimen Pack
Trueprep AUTO v2 Universal Cartridge Based Sample Prep Kit

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab Quattro

Truenat® Malaria Pv/Pf

A chip-based real-time duplex PCR test for the quantitative detection of Plasmodium vivax and Plasmodium falciparum in blood specimens, aiding malaria diagnosis.

Malaria

Malaria, with over 200 million cases annually, remains a major global health threat, especially in tropical and subtropical regions like sub-Saharan Africa, Southeast Asia, and parts of Latin America. Caused by Plasmodium parasites transmitted by Anopheles mosquitoes, it poses a diagnostic challenge due to low parasite loads, often leading to false negatives with traditional methods. PCR-based molecular tests offer higher sensitivity, enabling more accurate detection, early diagnosis, and timely interventions, especially in regions with low but ongoing transmission.

Burden

Most heavily impacts tropical and sub-tropical regions, particularly:

  • Southeast Asia (especially Indonesia, Philippines, Vietnam)
  • South Asia (India, Bangladesh)
  • Latin America (Brazil, Mexico)
  • Caribbean islands
  • Pacific islands
Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry
Assay typeQuantitative detection
Total Assay Time60 minutes
Clinical SpecimenHuman blood specimen
Gene TargetThe erythrocyte binding protein (EBP) gene which is expressed on the surface of the merozoites
Internal ControlsInternal Process Control - Extraction Control
Sensitivity100%
Specificity100%
LOD1553 copies/mL for Plasmodium falciparum plasmid DNA and 2569 copies/mL for Plasmodium vivax plasmid DNA.
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat® Malaria Pv/Pf micro PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tip
Test pack sizeCatalog No.
5 Tests601010005
25T601010025
50T601010050

Trueprep AUTO Universal Sample Pre-treatment Pack
Trueprep AUTO v2 Universal Cartridge-Based Sample Prep Kit

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab Quattro

Truenat® Dengue/Chikungunya

Truenat® Dengue/Chikungunya is a chip-based real-time duplex PCR test for the quantitative detection of dengue and chikungunya viruses in blood/serum/plasma, aiding in their differential diagnosis.

Dengue

A viral infection causing severe flu-like illness, the WHO defines it as a fast-emerging pandemic-prone viral disease transmitted by Aedes mosquitoes. With an estimated 100–400 million infections occurring each year, half of the world’s population is now at risk of dengue. While many dengue infections are asymptomatic or produce only mild illness, the virus can occasionally cause more severe cases, and even death.

Burden

Most heavily impacts tropical and sub-tropical regions, particularly:

  • Southeast Asia (especially Indonesia, Philippines, Vietnam)
  • South Asia (India, Bangladesh)
  • Latin America (Brazil, Mexico)
  • Caribbean islands
  • Pacific islands

Chikungunya

Chikungunya, transmitted by mosquitoes in Africa, Asia, and the Americas, causes fever and severe joint pain. Its symptoms resemble those of dengue and Zika, making misdiagnosis common. This highlights the need for more accurate molecular tests for proper diagnosis.

Burden

Predominantly affects:

  • Indian subcontinent
  • Southeast Asia
  • Parts of Africa
  • Caribbean islands
  • Central and South America
Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
Test NameTruenat® Dengue/Chikungunya
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry
Assay typeQuantitative detection
Total Assay Time60 minutes
Clinical SpecimenHuman blood/plasma/serum specimens
Gene TargetPart of 3' untranslated region (UTR) of the dengue genome and Non-structural protein 4(nsP4) gene of the Chikungunya genome
Internal ControlsInternal Process Control - Extraction Control
LOD139.76 copies/mL for Dengue; 180.45 copies/mL for Chikungunya
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat® Dengue/Chikungunya micro-PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tip
Pack SizeCat. No.
5T601040005
20T601040020
25T601040025
50T601040050

Trueprep AUTO Universal Sample Pre-treatment Pack
Trueprep AUTO v2 Universal Cartridge-Based Sample Prep Kit

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab Quattro

Truenat® Dengue

Truenat® Dengue is a chip-based real-time PCR test for quantitative detection of dengue virus in human blood/serum/plasma specimens and aiding diagnosis of dengue disease.

Dengue

A viral infection causing severe flu-like illness, the WHO defines it as a fast-emerging pandemic-prone viral disease transmitted by Aedes mosquitoes. With an estimated 100–400 million infections occurring each year, half of the world’s population is now at risk of dengue. While many dengue infections are asymptomatic or produce only mild illness, the virus can occasionally cause more severe cases, and even death.

Burden

Most heavily impacts tropical and sub-tropical regions, particularly:

  • Southeast Asia (especially Indonesia, Philippines, Vietnam)
  • South Asia (India, Bangladesh)
  • Latin America (Brazil, Mexico)
  • Caribbean islands
  • Pacific Islands
Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry
Assay typeQuantitative detection
Total Assay Time60 minutes
Clinical SpecimenHuman blood/plasma/serum specimens
Gene TargetPart of 3' untranslated region (UTR) of the dengue genome
Internal ControlsInternal Process Control - Extraction Control
Sensitivity100%
Specificity100%
LOD222.99 copies/mL
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat® Dengue micro-PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tip
Pack SizeCat. No.
5T601050005
20T601050020
25T601050025
50T601050050

Trueprep AUTO Universal Sample Pre-treatment Pack
Trueprep AUTO v2 Universal Cartridge-Based Sample Prep Kit

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab Quattro

Truenat® Chikungunya

Truenat® Chikungunya is a chip-based Real Time PCR Test for quantitative detection of Chikungunya virus in human blood/serum/plasma specimen and aids in the diagnosis of infection with Chikungunya

Chikungunya

Chikungunya, transmitted by mosquitoes in Africa, Asia, and the Americas, causes fever and severe joint pain. Its symptoms resemble those of dengue and Zika, making misdiagnosis common. This highlights the need for more accurate molecular tests for proper diagnosis.

Burden

Predominantly affects:

  • Indian subcontinent
  • Southeast Asia
  • Parts of Africa
  • Caribbean islands
  • Central and South America
Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
  • High primer specificity and sensitivity ensure maximum accuracy
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry
Assay typeQuantitative detection
Total Assay Time60 minutes
Clinical SpecimenHuman blood/plasma/serum specimens
Gene TargetNon-structural protein 4(nsP4) gene of the Chikungunya genome
Internal ControlsInternal Process Control - Extraction Control
Sensitivity100%
Specificity100%
LOD10 copies of RNA/reaction
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat® Dengue micro-PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tip
Pack SizeCat. No.
5T601060005
20T601060020
25T601060025
50T601060050

Trueprep AUTO Universal Sample Pre-treatment Pack
Trueprep AUTO v2 Universal Cartridge-Based Sample Prep Kit

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab Quattro

Truenat® HBV

Truenat® HBV is a chip-based Real Time PCR Test for quantitative estimation of the Hepatitis B Virus (HBV) in human blood/serum/plasma specimen and aids in the diagnosis of infection with Hepatitis B virus and in the estimation of viral load.

Hepatitis B

Hepatitis B is a viral infection that attacks the liver and can cause acute or chronic disease. WHO estimates that 254 million people were living with chronic hepatitis B infection in 2022, with 1.2 million new infections each year. It spreads through contact with infected blood, semen, or bodily fluids, often via unprotected sex, needle sharing, or from mother to child. While many recover from acute infection, chronic hepatitis B can lead to liver damage, cirrhosis, or liver cancer. Vaccination is highly effective, and antiviral treatments help manage chronic cases. Regular screening is essential for early detection and prevention of complications.

Burden

Highest prevalence in:

  • Western Pacific region
  • Africa
  • Southeast Asia
  • Areas with limited vaccination programs
Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
  • High primer specificity and sensitivity ensure maximum accuracy
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry
Assay typeQuantitative detection
Total Assay Time60 minutes
Clinical SpecimenHuman blood/serum/plasma specimen
Gene TargetPart of the core/pre-core region of HBV genome
Internal ControlsInternal Process Control - Extraction Control
Sensitivity100%
Specificity100%
LOD55.92 IU/ml
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat® HBV micro-PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tip
Pack SizeCat. No.
5T601090005
20T601090020
25T601090025
50T601090050

Trueprep AUTO Universal Sample Pre-treatment Pack
Trueprep AUTO v2 Universal Cartridge-Based Sample Prep Kit

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab Quattro

Truenat® HCV

Truenat® HCV is a chip-based Real Time PCR Test for quantitative detection and the diagnosis of Hepatitis C virus (HCV) in whole blood/plasma/serum and aids in the monitoring of HCV viral load of patients with HCV infection

Hepatitis C

Hepatitis C is a blood-borne virus causing liver inflammation, transmitted through exposure to blood from unsafe injection practices, unsafe health care, unscreened blood transfusions, injection drug use and sexual practices. Globally, an estimated 50 million people have chronic hepatitis C virus infection, with about 1.0 million new infections occurring per year. Direct-acting antiviral medicines (DAAs) can cure more than 95% of persons with hepatitis C infection, provided access to timely diagnosis and treatment.

Burden

Most affected regions:

  • Egypt
  • Pakistan
  • China
  • Mongolia
  • Central and East Asia
  • Parts of Africa
Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
  • High primer specificity and sensitivity ensure maximum accuracy
Assay MethodReal Time PCR based on Taqman chemistr
Assay typeQuantitative detection
Total Assay Time60 minutes
Clinical SpecimenWhole (venous) blood/plasma/serum
Gene Target3' UTR region of the HCV genome
Internal ControlsInternal Process Control - Extraction Control
Sensitivity100%
Specificity100%
LODGenotype and sample specific - consult IFU
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat® HCV micro-PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tip
Pack SizeCat. No.
5T601180005
20T601180020
25T601180025
50T601180050

Trueprep AUTO Universal Sample Pre-treatment Pack
Trueprep AUTO v2 Universal Cartridge-Based Sample Prep Kit

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab Quattro

Truenat® HAV

Truenat® HAV is a chip-based Real Time PCR Test for quantitative detection and diagnosis of Hepatitis A virus in human blood /serum/ plasma specimen and aids in the diagnosis of infection with Hepatitis A Virus. This test is also intended for qualitative detection and diagnosis of Hepatitis A Virus in Stool sample.

Hepatitis A

Hepatitis A is an inflammation of the liver that can cause mild to severe illness. The hepatitis A virus (HAV) is transmitted through ingestion of contaminated food and water or through direct contact with an infectious person. In low- and middle-income countries with poor sanitation and hygiene, hepatitis A infection is common, and by the age of 10, about 90% of children have been exposed to the virus.

Burden

Highest impact in:

  • Low-income countries
  • Areas with poor sanitation
  • Regions with limited access to clean water
  • Dense urban areas in developing countries
Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
  • High primer specificity and sensitivity ensure maximum accuracy
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry
Assay typeQuantitative detection (For blood/serum/plasma)
Qualitative detection (For stool)
Total Assay Time60 minutes
Clinical SpecimenWhole blood/plasma/serum, stool
Gene Target5’NCR of HAV genome
Internal ControlsInternal Process Control - Extraction Control
Sensitivity100%
Specificity100%
LOD87.7 IU/mL of Plasma
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat® Inf A,B/COVID-19 micro-PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tip
Pack SizeCat. No.
5T601320005
20T601320020
25T601320025
50T601320050

Trueprep AUTO Universal Sample Pre-treatment Pack
Trueprep AUTO v2 Universal Cartridge-Based Sample Prep Kit

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab Quattro

Truenat® HEV

Truenat® HEV is a chip-based Real Time PCR Test for quantitative detection and diagnosis of Hepatitis E virus in human blood /serum/ plasma specimen and aids in the diagnosis of infection with Hepatitis E Virus. This test is also intended for qualitative detection and diagnosis of Hepatitis E Virus in Stool sample.

Hepatitis E Virus

Hepatitis E virus (HEV) is a liver infection primarily transmitted through the fecal-oral route, often due to contaminated water or food. It is particularly prevalent in regions with poor sanitation and inadequate access to clean water, such as parts of Asia, Africa, and the Middle East. While most HEV infections are self-limiting and resolve within a few weeks, the virus can cause severe complications in pregnant women, potentially leading to acute liver failure and a high mortality rate. HEV is less likely to cause chronic infection compared to other hepatitis viruses, but it remains a significant public health concern in endemic areas.

Burden

Most prevalent in:

  • South Asia
  • Southeast Asia
  • Central Asia
  • Sub-Saharan Africa
  • Areas with poor water sanitation
Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
  • High primer specificity and sensitivity ensure maximum accuracy
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry
Assay typeQuantitative detection (For blood/serum/plasma)
Qualitative detection (For stool)
Total Assay Time60 minutes
Clinical SpecimenWhole blood/plasma/serum, stool
Gene TargetORF 1 poly protein gene of HEV genome
Internal ControlsInternal Process Control - Extraction Control
Sensitivity100%
Specificity100%
LOD516 copies/mL
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat® HEV micro-PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tip
Pack SizeCat. No.
5T601330005
20T601330020
25T601330025
50T601330050

Trueprep AUTO Universal Sample Pre-treatment Pack
Trueprep AUTO v2 Universal Cartridge-Based Sample Prep Kit

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab Quattro

Truenat® HIV-1/HIV-2

Truenat® HIV-1/HIV-2 is a chip-based Real Time Duplex PCR Test for quantitative detection and differential diagnosis of infection with human immunodeficiency virus type 1 & 2 (HIV-1 & 2) in whole blood/plasma/serum and aids in the monitoring of the HIV-1 & 2 viral loads in patients with HIV-1 and/or HIV-2 infection.

HIV-1 and HIV-2

HIV-1 and HIV-2 are two distinct types of the human immunodeficiency virus that cause acquired immunodeficiency syndrome (AIDS). HIV-1 is the most widespread strain globally, responsible for the majority of HIV infections. HIV-2, primarily found in West Africa, is less transmissible and generally progresses more slowly than HIV-1. Timely diagnosis and treatment initiation with anti-retroviral therapy can prevent transmission of the infection as well as opportunistic infections.

Burden

Highest prevalence in:

  • Sub-Saharan Africa
  • Southeast Asia
  • Eastern Europe
  • Caribbean
  • Latin America
Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
  • High primer specificity and sensitivity ensure maximum accuracy
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry
Assay typeQuantitative detection
Total Assay Time60 minutes
Clinical SpecimenPlasma
Gene TargetPol gene for HIV-1 and 5’ UTR for HIV-2 genome
Internal ControlsInternal Process Control - Extraction Control
Sensitivity100%
Specificity100%
LODHIV-1: 635 IU/mL, HIV-2: 1372.80 IU/mL
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat® Dengue micro-PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tip
Pack SizeCat. No.
5T601540005
20T601540020
25T601540025
50T601540050

Trueprep AUTO Universal Sample Pre-treatment Pack
Trueprep AUTO v2 Universal Cartridge-Based Sample Prep Kit

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab Quattro

Truenat® HPV-HR

Truenat® HPV-HR is a chip-based Real Time Duplex PCR Test for semi-quantitative detection of high risk Human Papillomavirus (HPV) types 16, 18, 31 and 45 in female cervical specimens collected by a clinician. It aids in the differential diagnosis of symptomatic or asymptomatic infection with high risk HPV types 16, 31 and 18, 45.

HPV-HR (High-Risk Human Papillomavirus)

Cervical cancer is one of the most common cancers in the world. Human papillomavirus (HPV) high-risk (HR) types, particularly HPV-16 and HPV-18, are responsible for the majority of cervical cancers worldwide. They are also linked to other cancers, including those of the anus, oropharynx, vulva, and penis. With over 600,000 new cases of cervical cancer diagnosed annually, HPV-HR remains a major public health concern, especially in low- and middle-income countries where screening and vaccination programs are limited.

Burden

Global presence with highest impact in:Highest prevalence in:

  • Low and middle-income countries
  • Sub-Saharan Africa
  • Latin America
  • South Asia
Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
  • High primer specificity and sensitivity ensure maximum accuracy
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry
Assay typeSemi-quantitative detection
Total Assay Time60 minutes
Clinical SpecimenFemale cervical specimens
Gene TargetRegions within the E6 and E7 genes of high
risk HPV types 16,18,31 and 45
Internal ControlsInternal Process Control - Extraction Control
Sensitivity97.70%
Specificity98.90%
LOD242.86 IU/mL for HPV 16 DNA, 277.44 IU/mL for HPV 18 DNA, 400.94 copies/ml for HPV 31 DNA, and 294.49 IU/mL HPV 45 DNA
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat® Dengue micro-PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tip
Pack SizeCat. No.
5T601220005
20T601220020
25T601220020
50T601220020

Trueprep AUTO Universal Sample Pre-treatment Pack
Trueprep AUTO v2 Universal Cartridge-Based Sample Prep Kit

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab Quattro

Truenat® HSV 1/2

Truenat® HSV 1/2 is a chip-based Real Time PCR Test for semi-quantitative detection of HSV 1/2 virus in genital swab/CSF specimens and aids in the diagnosis of infection with HSV 1/2 virus.

HSV-1 and HSV-2

According to the World Health Organization (WHO), Herpes Simplex Virus (HSV) is a prevalent viral infection characterized by two primary types: HSV-1 and HSV-2. While these are chronic, lifelong viral infections that primarily affect the oral and genital regions, causing periodic outbreaks of painful blisters or ulcers, timely diagnosis and antiviral treatments can help manage symptoms, reduce the frequency of outbreaks, and lower the risk of transmission.

Burden

Extensive worldwide distribution with the highest prevalence in:

  • Sub-Saharan Africa
  • Latin America
  • South and Southeast Asia
  • Caribbean regions
  • Areas with limited sexual health education and resources
Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
  • High primer specificity and sensitivity ensure maximum accuracy
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry
Assay typeSemi-quantitative detection
Total Assay Time60 minutes
Clinical SpecimenGenital swab/CSF specimens
Gene TargetDNA Polymerase (UL30) gene of Herpes simplex virus type 1 & 2 genome
Internal ControlsInternal Process Control - Extraction Control
Sensitivity100%
Specificity100%
LOD294 copies/mL
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat® Dengue micro-PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tip
Pack SizeCat. No.
5T601570005
20T601570020
25T601570025
50T601570050

Trueprep AUTO Universal Sample Pre-treatment Pack
Trueprep AUTO v2 Universal Cartridge-Based Sample Prep Kit

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab Quattro

Truenat® CT/NG

Truenat® CT/NG is a chip-based Real Time Duplex PCR Test for semi-quantitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae in female endocervical and vaginal swab specimens, male urethral swab specimen and male and female urine specimen and aids in the diagnosis of symptomatic or asymptomatic infection with Chlamydia trachomatis and/or Neisseria gonorrhoeae.

Chlamydia trachomatis

Chlamydia trachomatis is the most common STI worldwide, often presenting with mild or no symptoms. If untreated, it can cause complications like pelvic inflammatory disease (PID) and infertility in both men and women, as well as conjunctivitis and trachoma, a major cause of blindness in developing countries. Easily treatable with antibiotics, regular screening—especially for sexually active individuals under 25—is crucial to prevent long-term health issues.

Burden

Widespread globally with highest rates in:

  • Young adults (15-24 years)
  • Urban areas
  • Low-income communities
  • Regions with limited sexual health services
Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
  • High primer specificity and sensitivity ensure maximum accuracy
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry
Assay typeSemi-quantitative detection
Total Assay Time60 minutes
Clinical SpecimenFemale endocervical and vaginal swab specimens, male urethral swab specimen and male and female urine specimen
Gene TargetFor Chlamydia trachomatis assay, the target is a region within the cryptic plasmid DNA and ompA gene. For Neisseria gonorrhoeae assay, the target is porB gene and opaE gen
Internal ControlsInternal Process Control - Extraction Control
Sensitivity100%
Specificity100%
LOD274.67 copies/mL for Chlamydia trachomatis; 264.65 copies/mL for Neisseria gonorrhoeae
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat® Dengue micro-PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tipDNase & RNase free pipette tip
Pack SizeCat. No.
5T601160005
20T601160020
25T601160025
50T601160050

Trueprep AUTO Universal Sample Pre-treatment Pack
Trueprep AUTO v2 Universal Cartridge-Based Sample Prep Kit

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab Quattro

Truenat® Trich

Truenat® Trich is a chip-based Real Time PCR Test for semi-quantitative detection of Trichomonas vaginalis in female endocervical and vaginal swab specimens, male urethral swab specimen and male and female urine specimen and aids in the diagnosis of symptomatic or asymptomatic infection with Trichomonas vaginalis.

Trichomonas vaginalis

Definition: Trichomonas vaginalis, a protozoan parasite causing trichomoniasis, is a common non-viral sexually transmitted infection (STI) worldwide. While many infections are asymptomatic, untreated trichomoniasis can lead to complications such as pelvic inflammatory disease (PID) in women and increased susceptibility to HIV. A treatable and curable condition, regular screening in sexually active individuals is important to prevent transmission and health complications.

Burden

Most significantly impacts:

  • Sub-Saharan Africa
  • Latin America
  • Caribbean regions
  • Parts of Southeast Asia
  • Developing countries with limited sexual health resources
Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry
Assay typeSemi-quantitative detection
Total Assay Time60 minutes
Clinical SpecimenFemale endocervical and vaginal swab specimens, male urethral swab specimen and male and female urine specimen
Gene TargetMalate dehydrogenase in the T. vaginalis genome
Internal ControlsInternal Process Control - Extraction Control
Sensitivity95.83%
Specificity100%
LOD246.17 copies/ml
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat® Dengue micro-PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tip
Pack SizeCat. No.
5T601050005
20T601050020
25T601050025
50T601050050

Trueprep AUTO Universal Sample Pre-treatment Pack
Trueprep AUTO v2 Universal Cartridge-Based Sample Prep Kit

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab Quattro

Truenat® Rabies

Truenat® Rabies is a chip-based Real Time PCR Test for semi-quantitative detection of Rabies Virus in Cerebrospinal fluid (CSF), saliva, brain tissue, corneal swabs specimens of animals and aids in the diagnosis of Rabies virus

Rabies

WHO defines it as a viral infection transmitted through animal bites, almost always fatal once symptoms appear.

Burden

Highest risk in:

  • Rural areas of Africa and Asia
  • Areas with large stray dog populations
  • Regions with limited access to post-exposure prophylaxis
  • Poor communities with limited healthcare access
Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry
Assay typeSemi-quantitative detection
Total Assay Time60 minutes
Clinical SpecimenCerebrospinal fluid (CSF), saliva, brain tissue, corneal swabs specimens of animals
Gene TargetNucleoprotein gene of the Rabies genome
Internal ControlsInternal Process Control - Extraction Control
LOD87.7 IU/mL of Plasma
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat®Rabies micro-PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tip
Pack SizeCat. No.
5T601120005
20T601120020
25T601120025
50T601120050

Trueprep AUTO Universal Sample Pre-treatment Pack
Trueprep AUTO v2 Universal Cartridge-Based Sample Prep Kit

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab Quattro

Truenat® Nipah

Truenat® Nipah is a chip-based Real Time PCR test for semiquantitative detection and the diagnosis of Nipah virus in Oropharyngeal swab and aids in the diagnosis of infection with Nipah virus RNA.

Nipah

Definition: WHO defines it as a zoonotic virus causing severe respiratory illness and encephalitis, transmitted by fruit bats and through human-to-human contact.

Burden

Outbreaks concentrated in:

  • Bangladesh
  • India
  • Malaysia
  • Singapore
  • Areas with fruit bat populations
Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry
Assay typeSemi-quantitative detection
Total Assay Time60 minutes
Clinical SpecimenOropharyngeal swab specimen
Gene TargetNucleocaspid protein gene
Internal ControlsInternal Process Control - Extraction Control
Sensitivity100%
Specificity100%
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat®Nipah micro-PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tip
Pack SizeCat. No.
5T601390005
20T601390020
25T601390025
50T601390050

Trueprep AUTO Universal Sample Pre-treatment Pack
Trueprep AUTO v2 Universal Cartridge-Based Sample Prep Kit

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab Quattro

Truenat® EBV

Truenat® EBV is a chip-based Real Time PCR test for the quantitative detection of Epstein-Barr virus in human blood/serum/plasma and CSF specimens and aids in diagnosis of EBV infection.

Epstein-Barr Virus

Definition: WHO recognizes it as a herpes virus causing infectious mononucleosis and associated with certain cancers.

Burden

Worldwide distribution with variations in:

  • Age of first infection between developed and developing countries
  • Areas with different socioeconomic conditions
  • Regions with varying hygiene practices
Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry
Assay typeQuantitative detection
Total Assay Time60 minutes
Clinical SpecimenHuman blood/serum/plasma and CSF specimens
Gene TargetLMP2 gene of Epstein-Barr virus genome
Internal ControlsInternal Process Control - Extraction Control
Sensitivity100%
Specificity100%
LOD209 copies/mL
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat® EBV micro-PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tip
Pack SizeCat. No.
5T601600005
20T601600020
25T601600025
50T601600050

Trueprep AUTO Universal Sample Pre-treatment Pack
Trueprep AUTO v2 Universal Cartridge-Based Sample Prep Kit

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab Quattro

Truenat® CMV

Truenat® CMV is a chip-based Real Time PCR test for the quantitative detection of Cytomegalovirus in human plasma /whole blood specimens and aids in diagnosis of infection with Cytomegalovirus.

Cytomegalovirus

Definition: WHO defines it as a common virus that can cause serious disease in immunocompromised individuals and congenital infections.

Burden

Global presence with higher impact in:

  • Developing countries
  • Areas with high HIV prevalence
  • Regions with limited maternal healthcare
  • Communities with crowded living conditions
Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry
Assay typeQuantitative detection
Total Assay Time60 minutes
Clinical SpecimenHuman blood/serum/plasma specimens
Gene TargetUL55 or gB gene coding for
envelope glycoprotein B and RL11 gene coding for membrane glycoprotein RL11
Internal ControlsInternal Process Control - Extraction Control
Sensitivity100%
Specificity100%
LOD226.79 IU/mL
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat®CMV micro-PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tip
Pack SizeCat. No.
5T601590005
20T601590020
25T601590025
50T601590050

Trueprep AUTO Universal Sample Pre-treatment Pack
Trueprep AUTO v2 Universal Cartridge-Based Sample Prep Kit

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab Quattro

Truenat® Salmonella

Truenat® Salmonella is a chip-based Real Time PCR Test for qualitative detection and diagnosis of Salmonella in human blood and aids in the diagnosis of infection with Salmonella.

Salmonella

Salmonella is 1 of 4 key global causes of diarrhoeal diseases. While Most cases of salmonellosis are mild; however, sometimes it can be life-threatening. The severity of the disease depends on host factors and the serotype of Salmonella.
Antimicrobial resistance is a global public health concern and Salmonella is one of the microorganisms in which some resistant serotypes have emerged, affecting the food chain.
WHO defines it as bacteria causing food-borne illness, typically resulting in gastroenteritis but sometimes more severe systemic infections.

Burden

Worldwide distribution with highest impact in:

  • Low and middle-income countries
  • Areas with poor sanitation
  • Regions with limited food safety regulations
  • Tropical climates
Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
  • High primer specificity and sensitivity ensure maximum accuracy
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry
Assay typeQualitative detection
Total Assay Time60 minutes
Clinical SpecimenHuman blood
Gene Targetpmp' gene encoding the “Plasmid maintenance protein”
Internal ControlsInternal Process Control - Extraction Control
LOD417 copies/mL
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat®Salmonella micro-PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tip
Pack SizeCat. No.
5T601080005
20T601080020
25T601080025
50T601080050

Trueprep AUTO Universal Sample Pre-treatment Pack
Trueprep AUTO v2 Universal Cartridge-Based Sample Prep Kit

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab Quattro

Truenat® GBS

Truenat® GBS is a chip-based Real Time PCR test for semi-quantitative detection and diagnosis of group B streptococcus in vagino-rectal swabs, cerebrospinal fluid (CSF) and Blood/Serum/Plasma specimen and aids in the diagnosis of infection with group B streptococcus.

Group B Streptococcus

Group B streptococcus (GBS) is found in up to 35% of healthy women’s reproductive or gastrointestinal tracts. Pregnant women colonized with GBS can transmit the bacteria to their newborns during birth, leading to neonatal sepsis, meningitis, and other complications. GBS is also linked to maternal sepsis, stillbirths, preterm births, and can affect immunocompromised adults and the elderly. However, the highest incidence occurs in neonates and infants up to 3 months. Screening and understanding GBS infections’ clinical presentations and treatments are essential.

Burden

Significant impact in:

  • Developed countries with high maternal care access
  • Areas with high birth rates
  • Regions with limited access to prenatal screening
Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
  • High primer specificity and sensitivity ensure maximum accuracy
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry
Assay typeSemi-quantitative detection
Total Assay Time60 minutes
Clinical SpecimenVagino-rectal swabs, cerebrospinal fluid (CSF) and Blood/Serum/Plasma
Gene TargetcAMP factor gene
Internal ControlsInternal Process Control - Extraction Control
Sensitivity
Specificity
LOD686.21 copies/mL
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat®GBS micro-PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tip
Pack SizeCat. No.
5T601240005
20T601240020
25T601240025
50T601240050

Trueprep AUTO Universal Sample Pre-treatment Pack
Trueprep AUTO v2 Universal Cartridge-Based Sample Prep Kit

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab Quattro

Truenat® LTS

Truenat® LTS is a chip-based Real Time PCR Test for semi quantitative detection of Leptospira and aids in the diagnosis of Leptospirosis in human Blood/Serum/Plasma,cerebrospinal fluid (CSF) and urine specimen.

Leptospira

WHO defines it as bacteria causing leptospirosis, transmitted through contact with water or soil contaminated by infected animal urine.

Burden

Highest prevalence in

  • Tropical regions
  • Flood-prone areas
  • Rural farming communities
  • Urban slums with poor sanitation
Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
  • High primer specificity and sensitivity ensure maximum accuracy
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry
Assay typeSemi-quantitative detection
Total Assay Time60 minutes
Clinical SpecimenHuman blood/serum/plasma, CSF, and urine specimen
Gene TargetRepetitive elements present across genome
Internal ControlsInternal Process Control - Extraction Control
Sensitivity100%
Specificity100%
LOD736.62 copies/mL
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat® LTS micro-PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tip
Pack SizeCat. No.
5T601400005
20T601400020
25T601400025
50T601400050

Trueprep AUTO Universal Sample Pre-treatment Pack
Trueprep AUTO v2 Universal Cartridge-Based Sample Prep Kit

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab QuattroTrueprep AUTO v2

Truenat® Scrub T

Truenat® Scrub T is a chip-based Real Time PCR Test for quantitative detection of Scrub typhus bacteria in blood / Serum / Plasma specimens.Truenat® LTS is a chip-based Real Time PCR Test for semi quantitative detection of Leptospira and aids in the diagnosis of Leptospirosis in human Blood/Serum/Plasma,cerebrospinal fluid (CSF) and urine specimen.

Scrub Typhus Bacteria

WHO defines it as a mite-borne disease caused by Orientia tsutsugamushi, causing fever and potential organ failure.

Burden

Primarily affects:

  • South Asia
  • Southeast Asia
  • Pacific Islands
  • Rural areas with mite-infested vegetation
Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
  • High primer specificity and sensitivity ensure maximum accuracy
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry
Assay typeQuantitative detection
Total Assay Time60 minutes
Clinical SpecimenWhole blood/plasma/serum specimen
Gene TargethtrA gene of Orientia tsutsugamushi
Internal ControlsInternal Process Control - Extraction Control
Sensitivity100%
Specificity100%
LOD339 copies/mL
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat®Scrub T micro-PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tip
Pack SizeCat. No.
5T601450005
20T601450020
25T601450025
50T601450050

Trueprep AUTO Universal Sample Pre-treatment Pack
Trueprep AUTO v2 Universal Cartridge-Based Sample Prep Kit

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab Quattro

Truenat® Shigella

Truenat® Shigella is a chip-based Real Time PCR Test for semi quantitative detection of Shigella spp. in human stool specimen and aids in the diagnosis of infection with Shigella.

Shigella spp

Shigellosis, caused by Shigella bacteria, is a leading cause of diarrheal disease and bacillary dysentery, especially in low- and middle-income countries, with an estimated 270 million cases annually. In 2016, Shigella was the second-leading cause of diarrheal mortality, responsible for 212,000 deaths, or 13% of all diarrhea-related deaths, primarily affecting children under 5 in LMICs. Treatment includes antimicrobials, but the rise of antimicrobial resistance (AMR) complicates management increasing morbidity and mortality.

Burden

Highest impact in:

  • Developing countries
  • Areas with poor sanitation
  • Refugee camps
  • Crowded communities with limited clean water access
Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
  • High primer specificity and sensitivity ensure maximum accuracy
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry
Assay typeSemi-quantitative detection
Total Assay Time60 minutes
Clinical SpecimenHuman stool specimen
Gene TargetipgF gene producing invasion associated protein of Shigella genome
Internal ControlsInternal Process Control - Extraction Control
Sensitivity100%
Specificity100%
LOD413.88 copies/mL
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat®Shigella micro-PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tip
Pack SizeCat. No.
5T601470005
20T601470020
25T601470025
50T601470050

Trueprep AUTO Universal Sample Pre-treatment Pack
Trueprep AUTO v2 Universal Cartridge-Based Sample Prep Kit

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab Quattro

Truenat® CDI

Truenat® CDI is a chip-based Real Time PCR Test for semi-quantitative detection and diagnosis of Clostridium difficile infections in stool samples.

Clostridium difficile

WHO recognizes it as a bacterium causing severe diarrhea, often associated with antibiotic use and healthcare settings.

Burden

Most prevalent in:

  • Healthcare facilities worldwide
  • Countries with high antibiotic use
  • Elderly care facilities
  • Areas with advanced healthcare systems
Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
  • High primer specificity and sensitivity ensure maximum accuracy
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry
Assay typeSemi-quantitative detection
Total Assay Time60 minutes
Clinical SpecimenHuman stool specimen
Gene TargetGene Clostridium difficile toxin B protein
Internal ControlsInternal Process Control - Extraction Control
Sensitivity
Specificity
LOD625.78 copies/mL
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat®CDI micro-PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tip
Pack SizeCat. No.
5T601620005
20T601620020
25T601620025
50T601620050

Trueprep AUTO Universal Sample Pre-treatment Pack
Trueprep AUTO v2 Universal Cartridge-Based Sample Prep Kit

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab Quattro

Truenat® Cholera

Truenat® Cholera is a chip-based Real Time PCR Test for semi-quantitative detection of Vibrio cholerae in stool sample specimens and aids in the diagnosis of Cholera infections.

Cholera

A severe diarrheal disease, cholera can be fatal within hours if not treated. Researchers estimate that there are 1.3 to 4.0 million cases and 21 000 to 143 000 deaths from cholera worldwide each year. Effective management with rehydration therapy and antibiotics can save lives provided timely and accurate diagnosis.

Burden

Highest risk in:

  • Yemen
  • Haiti
  • Parts of Africa
  • Areas affected by natural disasters or conflict
  • Regions with poor water and sanitation infrastructure
Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
  • High primer specificity and sensitivity ensure maximum accuracy
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry
Assay typeSemi-quantitative detectio
Total Assay Time60 minutes
Clinical SpecimenHuman stool
Gene TargetCholera Enterotoxin
Internal ControlsInternal Process Control - Extraction Control
Sensitivity100%
Specificity100%
LOD254.92 copies/mL
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat®Cholera micro-PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tip
Pack SizeCat. No.
5T601500005
20T601500020
25T601500025
50T601500050

Trueprep AUTO Universal Sample Pre-treatment Pack
Trueprep AUTO v2 Universal Cartridge-Based Sample Prep Kit

 

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab Quattro

 

Truenat® M. leprae

Truenat® M. leprae is a chip-based Real Time PCR Test for the semi-quantitative detection of Mycobacterium leprae in slit skin smear specimens.

Mycobacterium leprae

Leprosy is a chronic infectious disease caused by Mycobacterium leprae that mainly affects the skin and peripheral nerves. If untreated, it can lead to permanent disabilities. The bacteria spread through respiratory droplets from close contact with untreated cases. Leprosy is curable with access to timely diagnosis and treatment with multidrug therapy (MDT).

Burden

Highest prevalence in:

  • India
  • Brazil
  • Indonesia
  • Bangladesh
  • Democratic Republic of Congo
  • Ethiopia
  • Nepal

 

Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
  • High primer specificity and sensitivity ensure maximum accuracy
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry
Assay typeSemi-quantitative detection
Total Assay Time60 minutes
Clinical SpecimenSlit skin smear specimen
Gene Target16S ribosomal RNA gene, sodA gene, and gene coding for RLEP region
Internal ControlsInternal Process Control - Extraction Control
Sensitivity100%
Specificity100%
LOD330 copies/mL
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat®M. leprae micro-PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tip
Pack SizeCat. No.
5T601700005
20T601700020
25T601700025
50T601700050

Trueprep AUTO Universal Sample Pre-treatment Pack
Trueprep AUTO v2 Universal Cartridge-Based Sample Prep Kit

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab Quattro

Truenat® HLA-B27

Truenat® HLA-B27 is a chip-based Real-Time PCR Test for qualitative detection of HLA-B27 in human blood specimens and aids in diagnosing HLA-B27 typing.

HLA-B27

While not a pathogen, WHO recognizes it as a genetic marker strongly associated with certain autoimmune conditions, particularly ankylosing spondylitis.

Burden

Highest prevalence in:

  • Northern European populations
  • Indigenous Arctic and Subarctic peoples
  • Varies significantly by ethnic group and geographic region
Key Features
  • Minimal extracted elute volume requirement of 6µL for high-efficiency
  • Sample-to-result in one hour (60 minutes), ensuring fast turnaround time
  • User-friendly single-use disposable consumables
  • Contamination/evaporation-resistant design for maximum control
  • Lyophilized ready-to-use PCR reagents
  • Reagent stability up to 30⁰C for 2 years
  • Minimal biosafety requirements
  • Smart chip with batch-specific data
  • Advanced Taqman chemistry-based technology
  • High primer specificity and sensitivity ensure maximum accuracy
Extraction MethodMicrofluidics Cartridge Based Automated in Trueprep AUTO v2
Assay MethodReal Time PCR based on Taqman chemistry
Assay typeQualitative detection
Total Assay Time60 minutes
Clinical SpecimenHuman blood
Gene TargetExon 2 of HLA-B
Internal ControlsInternal Process Control - Extraction Control
Sensitivity100%
Specificity100%
Kit Storage Temperature2-30℃

Each individually sealed pouch contains

  1. Truenat®HLA-B27 micro-PCR chip
  2. Microtube with freeze-dried RT PCR reagents
  3. DNase & RNase free pipette tip
Pack SizeCat. No.
5T601380005
20T601380020
25T601380025
50T601380050

Trueprep AUTO Universal Sample Pre-treatment Pack
Trueprep AUTO v2 Universal Cartridge-Based Sample Prep Kit

Trueprep AUTO v2
Truelab Uno Dx/Truelab Duo/Truelab Quattro