| Test
875 TQ - HIV-1 RNA by NASBA– viral load quantitation
|
| Method |
NucliSens®
HIV-1 QT – Quantitative
Nucleic Acid Sequence-Based Amplification (NASBA) |
| Specimen
Requirements |
4.0
ml (2.0 ml) Plasma PPT tube, Room temp. or frozen;
4.0 ml (2.0 ml) Plasma EDTA, citrate or heparin as anticoagulant;
separate and freeze within 24 hours of collection; 2.0ml
(1.0 ml) CSF, frozen. |
| Collection
& Transport |
Whole
blood collected in EDTA, citrate or heparin can be held
at room temp up to 24 hours before centrifuging to collect
the plasma; plasma should be held at 2-8∞C if shipping
within 14 days, ship on ice pack; plasma should be frozen
at -20∞C if storing and shipping >14 days, ship
on dry ice; CSF should be shipped frozen. |
| Causes
for Rejection |
Incorrect
anticoagulant; for plasma other than PPT tube, rejection
is necessary for plasma not separated within 24 hours
of collection; stored or shipped at incorrect temperature. |
| Specimen
Stability |
Whole
blood collected in EDTA, citrate or heparin can be held
at room temp up to 24 hours before centrifuging to collect
the plasma. Plasma stable up to 14 days at 2-8∞C;
stable > one year
at -70∞C; Frozen CSF stable indefinitely. |
| Reference
Range |
Less
than 51 copies/m (HIV-1 RNA viral load).
The linear range of this assay is 51 to 5,390,000 copies
/ ml |
| TAT |
2-7
days |
| CPT
Code |
87536,
HIV-1, quantification |
| NucliSens®
HIV-1 QT is an FDA approved in vitro nucleic acid amplification
test for the quantitation of Human Immunodeficiency
Virus Type 1 (HIV-1) RNA in human plasma.
The test is intended for use in conjunction with clinical
presentation and other laboratory markers of disease
progression for prognostic assessment of HIV-1 infected
patients, and for monitoring the effects of anti-retroviral
therapy by serial measurements of plasma HIV-1 RNA for
pediatric and adult patients.
Quantitation with NucliSens® HIV-1 QT is based on
co-amplification of HIV-1 RNA present in the sample
together with three RNA internal calibrators of known
low, medium and high RNA concentrations. The linear
range of the assay is determined to be 51 to 5,390,000
HIV-1 RNA copies/ml, a dynamic range that is approximately
10-fold greater than both standard AMPLICOR, version
1.0, assay and the QUANTIPLEX bDNA v3.0 assay, and approximately
100-fold greater than the ultra-sensitive AMPLICOR,
version 1.0 assay. |
