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Journal of Clinical Microbiology, April 2009, p. 889-895, Vol. 47, No. 4
0095-1137/09/$08.00+0     doi:10.1128/JCM.02231-08
Copyright © 2009, American Society for Microbiology. All Rights Reserved.

Comparison of the Abbott RealTime Human Immunodeficiency Virus Type 1 (HIV-1) Assay to the Cobas AmpliPrep/Cobas TaqMan HIV-1 Test: Workflow, Reliability, and Direct Costs{triangledown}

Cari R. Sloma,1 Jeffrey J. Germer,1 Tara M. Gerads,1 Jayawant N. Mandrekar,2 P. Shawn Mitchell,1 and Joseph D. C. Yao1*

Division of Clinical Microbiology, Department of Laboratory Medicine and Pathology,1 Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota 559052

Received 19 November 2008/ Returned for modification 17 January 2009/ Accepted 28 January 2009

The Abbott RealTime human immunodeficiency virus type 1 (HIV-1) assay (ART) and the Cobas AmpliPrep/Cobas TaqMan HIV-1 test (CTM) are commercially available assays for quantification of HIV-1 RNA in plasma. We evaluated performance characteristics, workflow, throughput, reliability, and direct costs of these assays. Both assays yielded good correlation of quantitative results (r = 0.95) among clinical specimens, with a mean difference of –0.34 log10 copies/ml. Testing of healthy donor plasma specimens yielded "target not detected" results by ART, with "HIV-1 RNA detected, <40 copies/ml" results for 3.3% (3 of 90 samples) of these specimens by CTM. Both the m2000sp/m2000rt (ART) and docked CAP/CTM96 (CTM) instrument systems were capable of operating with continuous, uninterrupted workflow. When daily maintenance and cleaning were included, ART and CTM run durations (5 h 52 min and 6 h 4 min, respectively) and hands-on times (53 min and 46 min, respectively) were similar for a run batch size of 24. While ART was more flexible in terms of run batch size, CTM required fewer user interventions and consistently produced higher specimen throughput rates at 8, 16, and 24 h. Assay run failure rates were 6.3% (1 of 16 runs) and 4.2% (1 of 24 runs) for ART and CTM, respectively (P = 1.000), with invalid specimen result rates of 1.0% (5 of 495 specimens) and 2.8% (11 of 399 specimens), respectively (P = 0.073). Direct reagent and consumable costs for each assay were comparable (difference of <10%). In selecting an assay for implementation, laboratories should consider how various assay and instrument features might impact laboratory operation and patient care.

* Corresponding author. Mailing address: Mayo Clinic, Su 1-602, 200 First Street SW, Rochester, MN 55905-0002. Phone: (507) 266-4533. Fax: (507) 266-4341. E-mail: jdcyao{at}mayo.edu

{triangledown} Published ahead of print on 4 February 2009.

Journal of Clinical Microbiology, April 2009, p. 889-895, Vol. 47, No. 4
0095-1137/09/$08.00+0     doi:10.1128/JCM.02231-08
Copyright © 2009, American Society for Microbiology. All Rights Reserved.



This article has been cited by other articles:

  • Pyne, M. T., Konnick, E. Q., Phansalkar, A., Hillyard, D. R. (2009). Evaluation of the Abbott Investigational Use Only RealTime Hepatitis C Virus (HCV) Assay and Comparison to the Roche TaqMan HCV Analyte-Specific Reagent Assay. J. Clin. Microbiol. 47: 2872-2878 [Abstract] [Full Text]  


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