APTIMA® HIV-1 RNA Qualitative Assay
Amplified assay for the detection of human immunodeficiency
virus (HIV-1) in human plasma
Disease Overview:
HIV, human immunodeficiency virus, is the virus that causes Acquired
Immunodeficiency Syndrome (AIDS). The virus primarily infects cells
of the immune system, T helper cells. Attachment occurs via the CD4
protein present in the T helper cell and over time, this leads to decline
in the number of T helper cells, resulting in a decline in the person's
immune system leads to a person's inability to fight infection.
The U.S. HIV incidence is approximately 40,000 new cases per year, down
from 100,000 in 1980's. There has been no change in over a decade, but
the incidence may be increasing. Transmission patterns have shifted,
as heterosexual transmission is increasing and accounted for 31% of
cases in 2004. There is a high incidence among young MSM (men who have
sex with men) and MSM of color, as well as an increased incidence among
teen girls and minorities.
Assay Overview:
The APTIMA HIV-1 RNA Qualitative Assay is the first Nucleic Acid Test
FDA Approved for
diagnosis of HIV-1 infection in human plasma.
The assay amplification targets the conserved regions in the LTR and
pol regions of the HIV-1 genome. Although the nucleic acid testing procedures
for HIV-1 virus detection typically targets the most conserved regions
of the genome, considerable effort must still be made to design an assay
capable of reliably detecting all genetic variants with equivalent sensitivity.
To monitor assay performance for each specimen reaction, an internal
control contained in the target capture reagent is added to each test
specimen and assay calibrator reaction. The internal control consists
of an
in vitro synthesized transcript containing a portion
of HIV-1 and a unique sequence targeted by the internal control probe.
The internal control cut-off calculation positioned to minimize the
number of invalid results while at the same time preventing occurrence
of false negative results.
The primary HIV-1 subtype in the US and Europe is HIV-1 Group M, subtype
B, while subtype C predominates in India and subtype F in Romania. The
appearance of different HIV-1 group M subtypes and group O in Europe
has been increasing and there have been a few instances of non-B group
M subtypes and group O infections in the US.
As HIV-1 subtypes are rapidly integrated into new geographical locations,
it is essential that assays are able to detect each HIV variant. There
have been reports of difficulties in consistent detection of non-B subtypes
with nucleic acid and serological testing. This is probably a result
of mismatches in the primer or probe-binding regions of the RNA or amplicon,
as HIV-1 group M and group O viruses can differ as much as 50% in their
overall sequences. However, the data indicates the TMA HIV-1 assay,
due to appropriate choice of primers & probes in the most conservative
HIV-1 genomic regions, is capable of sensitive detection of all the
major HIV-1 genetic variants, including groups N and O.
References:
- APTIMA HIV-1 RNA Qualitative Assay; 500236 Rev. A
- www.cdc.gov
- Clinical Care Options
- Journal of Viral Methods 2002, Linnen et al; Sensitive detection of genetic variants of HIV-1 & HCV assays based on TMA
- Journal of Clinical Microbiology, May 2002, p. 1761-1766, Kolk et al; Significant Closure of the HIV-1 and HCV Preseroconversion Detection Windows with a TMA-Driven Assay
- Journal of Clinical Microbiology, July 2002, p. 2387-2391, JB Jackson et al; Sensitivity of the PROCLEIX HIV-1/HCV Assay for Detection of HIV-1 and HCV RNA in a High-Risk Population)
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APTIMA HIV-1 RNA Qualitative
Assay
Description: An in vitro nucleic acid assay for use as
an aid in the diagnosis of HIV-1 infection, including acute or
primary infection. Presence of HIV-1 RNA in the plasma of patients
without antibodies to HIV-1 is indicative of acute or primary
HIV-1 infection. The assay may also be used as an additional test,
when it is reactive, to confirm HIV-1 infection in an individual
whose specimen is repeatedly reactive for HIV-1 antibodies.
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PI / MSDS |
| 100 Tests #2178 |
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APTIMA HIV-1 and HCV Auto Detect Reagents
Description: Detection reagents used on the LEADER HC+ Luminometer.
With bioburden testing.
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PI / MSDS |
| 1000 Tests (2*500) #2162 |
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APTIMA HIV-1 Proficiency
Panel
Description: Panel is to be used for assessing proficiency in
laboratory testing procedures.
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