COBAS^® AmpliPrep/COBAS^® TaqMan^® HIV-1 Qualitative Test v2.0

Giving children a chance

Fully automated qualitative test for Human Immunodeficiency Virus Type 1 (HIV-1)

Transmission of HIV from mothers to their infants can often be reduced through effective prevention programs. Unfortunately, some infants do become infected with HIV. Early diagnosis of their HIV-1 status allows children to receive appropriate medical care as quickly as possible. Roche’s dual-target HIV-1 Qualitative assay provides reliable and accurate information on whether the baby is truly infected with HIV or not.

Answering needs with innovative solutions

Infants born to mothers infected with HIV-1 may have maternal antibodies to HIV-1. Antibody tests are ineffective in children because of the mother’s antibodies remain in the child’s system following birth. In fact, antibody tests in infants may yield false positive results for up to 15 months, and the uncertainty surrounding the HIV status of the child has a negative effect on the potential clinical management of the child.¹

The use of dried blood spots (DBS) can facilitate PCR testing, and make sample collection easy, even from the smallest infant. By spotting small quantities of blood and collecting it on specially designed collection cards, blood collection and sample transportation is simplified while minimizing stress for the mother and child.

The COBAS^® AmpliPrep/COBAS^® TaqMan^® HIV-1 Qualitative Test, v2.0 is a qualitative nucleic acid amplification test for the detection of HIV-1 RNA and proviral DNA in plasma, anticoagulated fresh whole blood and dried blood spots.

Features

Targets two unique regions of the HIV-1 genome, gag and LTR, which are not subject to selective drug pressure. This provides diagnostic accuracy of test results even if mutations occur in one of the two regions
AmpErase^™ Enzymes reduce the risk of cross-contamination of samples or lab
Detects HIV-1 RNA which is indicative of active HIV infection. This allows for rapid implementation of anti-retroviral therapy in infected children¹

Detect simply and confidently for timely treatment

Simplify workflow with minimum instrument setup and ready-to-use reagents
Diagnose and treat early for improved disease and patient management
This test uses the COBAS^® AmpliPrep Instrument to automate sample processing and the COBAS^® TaqMan^® Analyzer or COBAS^® TaqMan^® 48 Analyzer to automate amplification and detection

Intended use

The COBAS^® AmpliPrep/COBAS^® TaqMan^® HIV-1 Qualitative Test, version 2.0 is an in vitro diagnostic, total nucleic acid amplification test for the qualitative detection of Human Immunodeficiency Virus Type 1 (HIV-1) DNA and RNA (or total nucleic acid, TNA) in human plasma or dried blood spots using the COBAS^®AmpliPrep Instrument for automated specimen processing and the COBAS^® TaqMan^®Analyzer or COBAS^®TaqMan^® 48 Analyzer for automated amplification and detection.

The test is a diagnostic test, indicated for individuals who are suspected to be actively infected with HIV-1. Detection of HIV-1 TNA is indicative of active HIV infection. Infants born to mothers infected with HIV-1 may have maternal antibodies to HIV-1, and the presence of HIV-1 nucleic acid in the infant indicates active HIV-1 infection. In adults, the test may be used as an aid in the diagnosis of HIV-1 infection.

Roche Dual Target HIV 1

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Ensuring timely medical care for HIV-infected children

Early HIV diagnosis that gives infants and young children a chance to receive timely medical care is a major challenge. The COBAS^® AmpliPrep/COBAS^® TaqMan^® HIV-1 Qualitative Test, v2.0 assay provides reliable, accurate information on whether or not an infant is infected.

Registration status

CE-IVD, not available in the United States

Package inserts

Access package inserts through your country’s Roche Diagnostics Website.

References

Sison AV, Campos JM. Laboratory methods for earlz detection of human immunodeficiency virus type 1 in newborns and infants. Clin Microbiol Rev. 1992;5(3):238-247.
Barennes H, Virak K, Rouet F, et al. Factors associated with the failure of first and second-line antiretroviral therapies therapy, a case control study in Cambodian HIV-1 infected children. BMC Res Notes. 2016;9:69.
World Health Organization (WHO). Global update on HIV treatment 2013: Results, Impact and Opportunities. http://www.who.int/hiv/pub/progressreports/update2013/en/. Accessed March 2, 2017.
Joint United Nations Programme on HIV/AIDS (UNAIDS). The GAP Report 2014: People Living with HIV. http://www.unaids.org/sites/default/files/media_asset/01_PeoplelivingwithHIV.pdf. Accessed March 2, 2017.
United Nations Children’s Fund. Towards an AIDS-Free Generation—Children and AIDS: Sixth Stocktaking Report, 2013. http://www.unaids.org/sites/default/files/media_asset/20131129_stocktaking_report_children_aids_en_0.pdf. Accessed March 2, 2017.
Joint United Nations Programme on HIV/AIDS (UNAIDS). Global update on HIV treatment 2013: Results, Impact and Opportunities—WHO report in partnership with UNICEF and UNAIDS. http://www.unaids.org/en/resources/documents/2013/20130630_treatment_report. March 2, 2017.

Performance

Sample types

EDTA plasma, dried blood spots
Whole blood requirement

70 µL of human whole blood onto a paper filter card
Sample input volume

1 mL EDTA plasma 1000 μL of SPEX reagent for eluted DBS
Limit of detection

20 cp/mL in EDTA plasma 300 cp/mL in dried blood spots
Genotypes inclusivity

HIV-1 Group M (subtype A through H, CRF01_AE), HIV-1 Group O, HIV-1 Group N
Diagnostic sensitivity

100%
Specificity

99.9%