Remarkable progress has been made since 2010 in the global fight to end the HIV epidemic. However, we still witness more than 1.5 M new HIV infections per year globally.  Over the last ten years, we have seen that with resource availability and access to care, it is possible to significantly impact HIV transmission and AIDS deaths. Achievement of the UNAIDS 2030 95-95-95 Fast-Track Targets includes access to high quality, HIV-1 viral load testing, and mitigation of emerging antiretroviral mutations that confer drug resistance. We are proud to offer both testing solutions to healthcare communities to fight HIV.

Product availability varies per country. Please contact your local sales representative for more details.

Want to use our solutions?  Contact us for details on our limited time offer.


HIV-1 resistance testing

One of the problems with the HIV virus is that it mutates very rapidly, rendering available antiretroviral therapies ineffective in suppressing the disease. Up to 10% of adults starting HIV treatment experience drug resistance to certain classes of drugs, and nearly 50% of infants born to mothers with HIV experience resistance to at least one class of drug. HIV now shows development of drug resistance to even the newer, highly effective integrase class of drugs. 

Our newly introduced Applied Biosystems HIV-1 Genotyping Kit with Integrase helps to detect and monitor drug resistance mutations in three main antiretroviral drug classes across a broad range of viral subtypes, helping to ensure that the right drug is delivered to the right patient at the right time. This kit—offered at access pricing—directly responds to the WHO’s recommendation that HIV drug resistance prevention, surveillance monitoring, and response be integrated into every national HIV program.

The TaqPath Seq HIV-1 Genotyping Kit harnesses gold standard Sanger sequencing technology to amplify and reliably sequence the diverse and rapidly evolving HIV-1 virus.

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Webinar: HIV-1 genotyping targeting integrase

We discuss how Sanger sequencing addresses local surveillance needs in various communities and hear thoughts regarding the future trends in HIV-1 genotyping for genetic and epidemiologic surveillance.

Watch webinar

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Survey HIVDR mutations with the CDC

Having an accurate and sensitive test for HIV-1 genetic variants that resist common antiretroviral therapeutics is critical for epidemiologic and genetic surveillance studies. Here, a scientist from the United States Centers for Disease Control (CDC) discusses the CDC’s experience investigating this assay for monitoring drug resistance mutations in the protease, reverse transcriptase, and integrase regions of the pol gene.

Watch presentation

The TaqPath Seq HIV-1 Genotyping Kit features:

  • A standardized, cost-effective assay in a scalable workflow
  • A total workflow of about 20 hours for processing extracted viral RNA from EDTA plasma or DBS to results, with a total hands-on time of ~4.5 hours
  • The ability to detect mutations in the protease, reverse transcriptase, and integrase regions of the HIV-1 pol gene in subtypes A, B, C, D, F, G, CRF01_AE, CRF02_AG, and CRF06_CPX


Assay workflow

Nucleic acids from plasma or dried blood spot (DBS) samples are extracted.

Amplification module

After sample processing and RNA extraction, samples undergo an initial reverse transcription + PCR, followed by a second nested PCR step for mutation targets of interest. The TaqPath Seq HIV-1 Genotyping Kit includes the RT-PCR master mix, the nested PCR master mix, and necessary positive and negative controls that allow for a simple, streamlined workflow as you move into your cleanup and sequencing steps.

Sequencing

Once you confirm and clean up your targeted PCR product, the remainder of the TaqPath Seq HIV-1 Genotyping Kit is used for cycle sequencing. Included in this kit are the forward/reverse pre-formulated sequencing mixes for the targets of interest.

Data analysis and results

Analyze the sequencing traces by exporting the AB1 files from the 3500 Series or 3500 Dx Series Genetic Analyzer for use in downstream analysis and reporting software.

Note: To learn more about available commercial software, consult the WHO documents listed in “Related documentation" on page 48 of the Instructions for Use.

Step 1 : Step 1: Nucleic acid extraction

Nucleic acids from plasma or dried blood spot (DBS) samples are extracted.

Step 2 : Step 2: Amplification module
Amplification module

After sample processing and RNA extraction, samples undergo an initial reverse transcription + PCR, followed by a second nested PCR step for mutation targets of interest. The TaqPath Seq HIV-1 Genotyping Kit includes the RT-PCR master mix, the nested PCR master mix, and necessary positive and negative controls that allow for a simple, streamlined workflow as you move into your cleanup and sequencing steps.

Step 3 : Step 3: Sequencing
Sequencing

Once you confirm and clean up your targeted PCR product, the remainder of the TaqPath Seq HIV-1 Genotyping Kit is used for cycle sequencing. Included in this kit are the forward/reverse pre-formulated sequencing mixes for the targets of interest.

Step 4 : Step 4: Data analysis and results
Data analysis and results

Analyze the sequencing traces by exporting the AB1 files from the 3500 Series or 3500 Dx Series Genetic Analyzer for use in downstream analysis and reporting software.

Note: To learn more about available commercial software, consult the WHO documents listed in “Related documentation" on page 48 of the Instructions for Use.

TaqPath Seq HIV-1 Genotyping Kit workflow
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Access pricing available to eligible customers. Contact us to learn more.

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HIV-1 diagnostic and viral load testing

Quantitative and qualitative PCR testing of HIV-1 viral levels in blood is an essential tool in the care and management of persons living with HIV. Frequent monitoring of HIV-1 viral load can serve as an early, first-step indication of the development of drug resistance.  

Applied Biosystems TaqPath Menu | GeneProof® HIV Type 1 (HIV-1) Diagnostic PCR Kit features:

Dual target detection

  • Protection against detection failures caused by virus mutations

 

Contamination reduction

  • Ready-to-use Master Mix contains uracil-DNA glycosylase (UNG) and dUTPs reducing possible carryover contamination

 

Qualitative and quantitative detection

  • Monitoring of pathogen level in time
  • Full traceability to WHO standards

 

Easy-to-use concept

  • Single tube ready-to-use Master Mix contains all components for PCR amplification
  • No additional pipetting of PCR reagents is necessary

 

Device compatibility

  • Compatible with a wide range of real-time PCR devices

 


Resources

HIV-1 resistance testing

ASLM content

HIV-1 webinar

AIDS 2022 satellite symposium

For In Vitro Diagnostic Use. Not available in all countries.

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