Experience with PCR screening.
The COBAS AmpliScreen Hepatitis C (HCV) Test, Version 2.0, which is designed for screening pools composed of samples from individual units of blood or plasma, employs a MultiPrep sample processing procedure that simultaneously extracts and concentrates HCV, HIV-1 and Hepatitis B virus particles from plasma. An HCV Internal Control (IC) RNA serves as an extraction and amplification control for each independently processed sample. Processed samples are amplified by RT-PCR using HCV-specific complementary primers and detected by hybridization of the amplified products to HCV- and IC-specific oligonucleotide probes. The analytical sensitivity of the test is 25 International Units (IU) of HCV per mL of pooled plasma; all HCV genotypes are detected with similar efficiency. The test detected HCV RNA 23 to 32 days prior to anti-HCV antibody seroconversion for four of the five seroconversion panels tested. The test had sufficient sensitivity to reproducibly detect a single infected unit containing 2.4 x 10(3) copies of HCV per mL in a pool with 23 uninfected units. COBAS AmpliScreen tests for HIV-1 and HBV now being validated by Roche Molecular Systems also incorporate the MultiPrep specimen processing method, thereby making it possible to use a single processed specimen to screen for all three viruses.
Sun
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Roche Molecular Systems, Inc., Pleasanton, CA 94566, USA.
Jayakar
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Yeh
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Mendoza
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Wisbeski
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MH
Iszczyszyn
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W
Dragon
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EA
D005838:Genotype; D015658:HIV Infections / Q000097:blood / Q000821:virology; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification*; D006509:Hepatitis B / Q000097:blood / Q000821:virology; D006526:Hepatitis C / Q000097:blood / Q000517:prevention & control* / Q000821:virology; D006801:Humans; D008403:Mass Screening / Q000379:methods; D016133:Polymerase Chain Reaction / Q000379:methods; D012367:RNA, Viral / Q000097:blood*; D011933:Reagent Kits, Diagnostic / Q000706:statistics & numerical data*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic