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Journal of Clinical Microbiology, March 2002, p. 768-773, Vol. 40, No. 3
0095-1137/02/$04.00+0     DOI: 10.1128/JCM.40.3.768-773.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.

Performance Characteristics of the COBAS Amplicor Hepatitis C Virus (HCV) Monitor, Version 2.0, International Unit Assay and the National Genetics Institute HCV Superquant Assay

Eric Q. Konnick,1* Maria Erali,1 Edward R. Ashwood,1,2 and David R. Hillyard1,2

ARUP Institute for Clinical and Experimental Pathology,1 Department of Pathology, University of Utah Health Sciences Center, Salt Lake City, Utah2

Received 25 April 2001/ Accepted 21 December 2001

The COBAS Amplicor Hepatitis C Virus (HCV) Monitor assay, version 2.0, which reports in international units per milliliter, was compared to the assay reported in copies per milliliter by analyzing dilution series and clinical plasma samples by both methods. In addition, the Amplicor international unit assay was compared to the National Genetics Institute HCV Superquant assay. The dilution series ranged from <100 to 5,000,000 HCV RNA copies/ml and consisted of 32 points, assayed in triplicate in each assay. Thirty clinical samples ranging from 1,000 to 1,000,000 HCV RNA copies/ml were assayed in duplicate. Deming regression analysis comparing the Amplicor HCV RNA international units-per-milliliter and copies-per-milliliter assays was calculated as follows: (Amplicor international units per milliliter) = 1.030(Amplicor copies per milliliter) - 0.392; R2 = 0.981; n = 28; Sy/x (standard error of the estimate) = 0.129. The linearity of the Amplicor international units-per-milliliter assay was as follows: observed = 0.886(expected) + 0.437; R2 = 0.983; n = 30. The linearity of the Superquant assay was as follows: observed= 0.918 (expected) + 0.436; R2 = 0.986; n = 32. Deming regression analysis comparing the Amplicor and Superquant assays was calculated as follows: Superquant = 1.066(Amplicor) - 0.0197; R2 = 0.908; Sy/x = 0.308; n = 28. The Amplicor and Superquant assays were linear through the range of 600 to 600,000 IU of HCV RNA/ml and ~300 to 5,000,000 HCV RNA copies/ml, respectively. The narrow range of the Amplicor assay means that some samples will require dilution and retesting for accurate quantification above 600,000 IU of HCV RNA/ml. The Amplicor and Superquant assays agreed well within the range of 600 to 600,000 IU of HCV RNA/ml (~1,000 to ~1,000,000 HCV RNA copies/ml). Overall, the Amplicor and Superquant assays agree well, and results obtained in one assay could be expected to compare well with results from the other when reported in copies per milliliter.

* Corresponding author. Mailing address: ARUP Institute for Clinical and Experimental Pathology, University of Utah Health Sciences Center, 500 Chipeta Way, Salt Lake City, UT 84108. Phone: (801) 583-2787, ext. 2225. Fax: (801) 584-5207 E-mail: KonnicE{at}ARUPLab.com.

Journal of Clinical Microbiology, March 2002, p. 768-773, Vol. 40, No. 3
0095-1137/02/$04.00+0     DOI: 10.1128/JCM.40.3.768-773.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.



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