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Test Name:
Donor, HIV-1 RNA, HCV RNA, and HBV DNA Screen, by Multiplex RT-PCR
- SBMF No:
22080 - Performance Lab Name:
Flow Cytometry/Molecular Pathology - Test Mnemonic:
NAT HIVHCV - ABN:
N/A - CPT Code:
N/A - LOINC Code:
59052-1; 59052-1; 59052-1 - Also Known As:
HCV NAT, HIV NAT, and HBV NAT - Spec Type:
Plasma - Spec Container:
Lavender top (EDTA) tube
Other anticoagulants (CPD, CPDA1, CP2D, ACDA, and 4% Sodium Citrate) may be used at the discretion of the Department Manager - Pref Vol:
3.0 mL - Fasting:
No - Spec Collect:
Routine blood donor collection - Spec Stability:
Blood collected in EDTA anticoagulant may be stored at 2 - 30°C for up to 72 hours from time of draw, followed by ab additional two days at 2 – 8°C. For storage longer than five days, remove the plasma from the red blood cells by centrifugation at 800 – 1,600 x g for 20 minutes, Following removal, plasma may be stored at 2 – 8°C for an additional seven days. Alternatively, plasma may be stored at ≤ -18°C for up to 30 days. EDTA plasma may be frozen and thawed a maximum of three (3) times.
Blood collected in CPD, CPDA1, or CP2D may be stored for up to 72 hours at 2 - 30°prior to plasma separation. Following centrifugation of the CPD, CPDA1 or CP2D specimens at 800 – 1,600 x g for 20 minutes, plasma may be stored at 2 - 8°C for an additional seven days. Alternatively, plasma separated from the red blood cells may be stored at ≤ -18°C for up to 30 days. CPD, CPDA1, or CP2D plasma can be frozen and thawed a maximum of three (3) times.
Apheresis plasma in ACDA or 4% Sodium Citrate anticoagulants may be stored for up to 72 hours from time of drawn at 2 - 30°C. Apheresis plasma may be stored for up to 30 days at ≤ -18°C.
- Spec Reject:
Frozen whole blood sample
Sample collected in Heparin anticoagulant - Methodology:
cobas® TaqScreen MPX Test - Use:
The cobas® TaqScreen MPX Test, for use with the cobas s 201 system, is a qualitative in vitro test for the direct detection of HIV-1 Group M RNA, HIV-1 Group O RNA, HIV-2 RNA, HCV RNA, and HBV DNA in human plasma.
This test is intended for use to screen donor samples for HIV-1 Group M RNA, HCV RNA, and HBV DNA in plasma specimen from individual human donors, including donors of whole blood and blood components and other living donors. This test is not intended to use to screen donations of source plasma, from paid donors.
This test is also intended for use in testing plasma specimens to screen individual organ donors when specimens are obtained while the donor’s heart is still beating. This test is not intended for use on samples of cord blood.
Plasma from all donors may be screened as individual samples. For donations of whole blood and blood components, plasma may be tested individually or in pools comprised of not more than six equal aliquots of individual specimens in conjunction with serology tests for HIV, HCV, or HBV. For donors of hematopoietic stem/progenitor cells (HPCs) sourced from bone marrow, peripheral blood or cord blood, and donor lymphocytes for infusion (DLI) plasma may be tested in pools of equal aliquots of not more than 6 individual donor specimens.
This test detects HIV-1 Group O RNA in specimens that are positive for anti-HIV-1 Group O antibodies, and HIV-2 RNA in specimens that are positive for anti-HIV-2 antibodies. However, detection of HIV-1 Group O RNA or HIV-2 RNA in specimens negative for anti-HIV-1 Group O antibodies or anti-HIV-2 antibodies, respectively, has not been demonstrated.
This assay is not intended for use as an aid in diagnosis of infection with HIV, HCV, or HBV.
- Clinical Significance:
A major concern regarding the transfusion of blood and blood components is the potential for transmission of viral infections, particularly with Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2), Hepatitis C virus (HCV), and Hepatitis B Virus (HBV). These agents are primarily transmitted by exposure to contaminated blood or blood and plasma products, exposure to certain body tissues or fluids, by sexual contact or by an infected mother to the newborn child.
HIV-1 is prevalent globally, with an estimated overall prevalence of 1.1% (0.56% in North American and 0.25% in Western Europe). Persons infected with HIV-1 can experience a brief, initially acute, flu-like illness associated with high levels of viremia in peripheral blood within 3-6 weeks of initial infection. There are currently three principal genetic groups for HIV1: Group M (main), Group N (non-M-non-O), and Group O (outlier). Group M is highly prevalent and is divided into 9 subtypes as well as several circulating recombinant forms (CRFs).
HIV-2 was first isolated in 1986 from patients in West Africa. Both HIV-1 and HIV-2 have the same modes of transmission and are associated with similar opportunistic infections and Acquired Immunodeficiency Syndrome (AIDS). The prevalence of HIV-2 in some African nations reaches more than 1%, and HIV-2 is a growing concern in certain parts of Europe and India. The first case of HIV-2 infection in the United States was diagnosed in 1987. The Centers for Disease Control and Prevention (CDC) advise that continued surveillance is needed to monitor HIV-2 in the US population.
HCV is considered to be the principal etiologic agent responsible for 90%-95% of the post transfusion non-A and Non-B hepatitis cases. HCV occurs globally but the incidence is not well known because the infection is generally asymptomatic. However, the reported prevalence varies from 0.5 – 2.0% in Western Europe as to high as 20% in Egypt. More than 2 billion people alive today have been infected with HBV at some time in their lives. Of these, about 350 million remain infected chronically and become carriers of the virus. Three quarters of the world’s population live in areas where there are high levels of infection. Every year there are over 4 million acute clinical cases of HBV.
Serological screening assays have greatly reduced, but not eliminated, the risk of transmission of viral infections by transfusion of blood and blood products. Testing of whole blood and source plasma donations for HBV was initiated with HBsAg assays in the early 1970’s and anti-HBc in the 1980’s. In addition to HBV screening, blood and plasma donations are routinely tested for HIV-1 and HIV-2 by screening with enzyme immunoassays (EIAs) and for anti-HCV by EIAs. Public demand for higher standards of screening for infectious agents in transfusion products has fueled the advancement of nucleic acid test (NAT) technology. Studies have shown that testing for viral nucleic acids (HIV-1 RNA, HCV RNA and HBV DNA) can further reduce the transmission risk of these agents in blood donations made during the seroconversion window period. This window period has been estimated as 22 days on average, but may be as long as 6 months, for HIV-1. With the implementation of HIV-1 mini-pool NAT testing, the infectious window period has been significantly shortened and the current risk of HIV-1 transmission is estimated to be approximately 1 in 2 million donations. Similarly, the introduction of HCV RNA NAT reduced the antibody negative window period by approximately 60 days, with a current estimated risk of approximately 1 – 2 in 1 million donations. HBV DNA NAT screening is being increasingly adopted. Studies from countries with low, moderate and high HBV prevalence have demonstrated NAT yield from window period and late stage HBV-infected donors, thus demonstrating reduced incidence of transfusion transmitted HBV.
The cobas® TaqScreen MPX Test is a qualitative test that enables the simultaneous detection of HIV-1 Group M and Group O RNA, HIV-2 RNA, HCV RNA, and HBV DNA in infected pooled and individual plasma donations. The cobas® TaqScreen MPX Test uses a generic nucleic acid preparation technique on the COBAS® AmpliPrep Instrument. HIV-1 Groups M and O RNA, HIV-2 RNA, HCV RNA, and HBV DNA are amplified and detected using automated, real time PCR amplification on the COBAS® TaqMan® Analyzer. The test incorporates an Internal Control for monitoring test performance in each individual test as well as the AmpErase enzyme to reduce potential contamination by previously amplified material (amplicon). The cobas® TaqScreen MPX Test does not discriminate which virus was detected in a specimen. The reactive sample is sent out for individual target identification (Discriminatory Testing).
- Reference Range:
Negative - Additional Test Info:
Non-negative samples are sent to a reference laboratory for confirmation and identification of positives - Test Type:
BLOOD BANK
