Clinical specificity and sensitivity of a blood screening assay for detection of HIV-1 and HCV RNA

Transfusion

Volumn 42, Issue 7, 2002, Pages 876-885

  Vargo, Janet ^{a,b,c,d,e,f,g,h}   Smith, Katie ^{a,b,c,d,e,f,g,h}   Knott, Caroline ^{a,b,c,d,e,f,g,h}   Wang, Songbai ^{a,b,c,d,e,f,g,h}   Fang, Chyang ^{a,b,c,d,e,f,g,h}   McDonough, Sherrol ^{a,b,c,d,e,f,g,h}   Giachetti, Cristina ^{a,b,c,d,e,f,g,h}   Caglioti, Sally ^{a,b,c,d,e,f,g,h}   Gammon, Richard ^{a,b,c,d,e,f,g,h}   Gilbert, Denise ^{a,b,c,d,e,f,g,h}   Jackson, J Brooks ^{a,b,c,d,e,f,g,h}   Richards, William ^{a,b,c,d,e,f,g,h}   Stramer, Susan ^{a,b,c,d,e,f,g,h}   Mimms, Larry ^{a,b,c,d,e,f,g,h}  

^a Gen Probe Incorporated   (United States)

^b NOVARTIS PHARMA AG   (Switzerland)

^c Blood Systems Laboratories   (United States)

^d Independent Blood Centers   (United States)

^e Florida Blood Services   (United States)

^f JOHNS HOPKINS UNIVERSITY   (United States)

^g BLOOD RESEARCH INSTITUTE   (United States)

^h AMERICAN RED CROSS   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

VIRUS RNA;

ANALYTICAL EQUIPMENT; ARTICLE; BLOOD; BLOOD DONOR; DISEASE TRANSMISSION; GENETICS; GENOTYPE; HEPATITIS C; HEPATITIS C VIRUS; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MASS SCREENING; NUCLEIC ACID AMPLIFICATION; PREDICTION AND FORECASTING; SENSITIVITY AND SPECIFICITY; STANDARD; VALIDATION STUDY; VIROLOGY;

BLOOD; BLOOD DONORS; GENOTYPE; HEPACIVIRUS; HEPATITIS C; HIV INFECTIONS; HIV SEROPOSITIVITY; HIV-1; HUMANS; MASS SCREENING; NUCLEIC ACID AMPLIFICATION TECHNIQUES; PREDICTIVE VALUE OF TESTS; REAGENT KITS, DIAGNOSTIC; RNA, VIRAL; SENSITIVITY AND SPECIFICITY;

EID: 18744395821     PISSN: 00411132     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1537-2995.2002.00130.x     Document Type: Article

References (21)

1. 1 Committee for Proprietary Medicinal Products (CPMP). The Introduction of nucleic acid amplification technology (NAT) for the detection of hepatitis C virus RNA in plasma pools (CPMP/BWP/390/97). London: The European Agency for the Evaluation of Medicinal Products, Human Medicines Evaluation Unit; 1998.
2. 2 Kleinman S, Stramer S, Mimms L, et al., for the NAT/Retrovirus Epidemiology Donor Study Group. Comparison of preliminary observed yield of HCV and HIV minipool (MP) nucleic acid testing (NAT) with predictions from the incidence/window period (INC/WP) model (Abstract). Transfusion 2000 ; 40 (Suppl): 4S.
3. 3 Gallarda JL, Dragon E. Blood screening by nucleic acid amplification technology: current issues, future challenges. Mol Diagn 2000 ; 5: 11 ‐ 22.
4. 4 Busch MP, Kleinman SH, Jackson B, et al. Committee report: nucleic acid amplification testing of blood donors for transfusion‐transmitted infectious diseases. Report of the Interorganizational Task Force on Nucleic Acid Amplification Testing of Blood Donors. Transfusion 2000 ; 40: 143 ‐ 59.
5. 5 Giachetti C, Linnen J, Kolk DP, et al. Highly sensitive multiplex assay for detection of HIV‐1 and HCV RNA. J Clin Microbiol, submitted for publication.
6. 6 McDonough SH, Giachetti C, Yang Y, et al. High throughput assay for the simultaneous or separate detection of human immunodeficiency virus (HIV) and hepatitis type C virus (HCV). Infusion Ther Transfus Med 1998 ; 25: 164 ‐ 9.
7. 7 O'Brien TR, George JR, Epstein JS. Testing for antibodies to human immunodeficiency virus type 2 in the United States. Morbidity and Mortality Weekly Report 1992;41:1‐9.
8. 8 Roche Diagnostics. Package insert, COBAS AMPLICOR HIV‐1 Monitor test. Version 1.5. Basel, Switzerland: Roche Diagnostics; 1999.
9. 9 National Genetic Institute (NGI, Culver City, CA), personal communication.
10. 10 Linnen JM, Gilker JM, Menez A, et al. Sensitive detection of genetic variants of HIV‐1 and HCV with an HIV‐1/HCV assay based on transcription‐mediated amplification. J Virol Methods 2002 ; 102: 139 ‐ 55.
11. 11 Stramer SL, et al. Application of nucleic acid testing to blood borne pathogens and emerging technologies OBRR/CBER/FDA workshop, Dec. 4, 2001. Washington.
12. 12 Nubling CM, Chudy M, Lower J. Validation of HCV‐NAT assays and experience with NAT application for blood screening in Germany. Biologicals 1999 ; 27: 291 ‐ 4.
13. 13 Roth WK, Weber M, Seifried E. Feasibility and efficacy of routine PCR screening of blood donations for hepatitis C virus, hepatitis B virus, and HIV‐1 in a blood‐bank setting. Lancet 1999 ; 353: 359 ‐ 63.
14. 14 Gessonri G, Barin P, Marchioni G. HCV‐RNA screening in a medium size Italian transfusion service using a commercial PCR method: one year's experience. Transfus Med 2001 ; 11: 116 ‐ 7.
15. 15 Meng Q, Wong C, Rangachari A, et al. Automated multiplex assay system for simultaneous detection of hepatitis B virus DNA, hepatitis C virus RNA, and human immunodeficiency virus type 1 RNA. J Clin Microbiol 2001 ; 39: 2937 ‐ 45.
16. 16 Schreiber GB, Busch MP, Kleinman SH, Korelitz JJ. The risk of transfusion‐transmitted viral infections. The Retrovirus Epidemiology Donor Study. New Engl J Med 1996 ; 334: 1685 ‐ 90.
17. 17 Busch MP, Satten GA. Time course of viremia and antibody seroconversion following human immunodeficiency virus exposure. Am J Med 1997 ; 102: 117 ‐ 24 ; discussion: 125‐6.
18. 18 Busch MP, Rawal BD, Fiebig EW, et al. Dynamics of HCV viremia and seroconversion in transfusion‐acquired HCV infections (abstract). Transfusion 1998 ; 38 (Suppl): 72S.
19. 19 Kleinman SH, Busch MP. The risks of transfusion‐transmitted infection: direct estimation and mathematical modelling. Bailliere's Best Pract Clin Haematol 2000 ; 13: 631 ‐ 49.
20. 20 Busch MP, Giachetti C, Conrad A, et al. Dynamics of HCV viremia during early HCV infection: implications for minipool (MP) vs individual donation (ID) nucleic acid amplification testing (NAT) (abstract). Transfusion 2000 ; 40 (Suppl): 25 ‐ 6S.
21. 21 Kolk D, Dockter J, Linnen J, et al. Significant closure of the HIV‐1 and HCV pre‐seroconversion detection windows with a TMA‐driven HIV‐1/HCV Assay. J Clin Microbiol 2002 ; 40: 1761 ‐ 6.