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Journal of Clinical Microbiology, December 2008, p. 3941-3945, Vol. 46, No. 12
0095-1137/08/$08.00+0     doi:10.1128/JCM.00754-08
Copyright © 2008, American Society for Microbiology. All Rights Reserved.

Performance of a Novel Human Immunodeficiency Virus (HIV) Type 1 Total Nucleic Acid-Based Real-Time PCR Assay Using Whole Blood and Dried Blood Spots for Diagnosis of HIV in Infants{triangledown}

Wendy Stevens,* Linda Erasmus, Matsidisho Moloi, Thabo Taleng, and Somaya Sarang

University of the Witwatersrand and the National Health Laboratory Services, Johannesburg 2000, South Africa

Received 21 April 2008/ Returned for modification 9 June 2008/ Accepted 3 October 2008

The new Cobas AmpliPrep/Cobas TaqMan HIV-1 Qual test offers advanced automation for the detection of human immunodeficiency virus type 1 (HIV-1) RNA and DNA in dried blood spots (DBS) and whole blood. An analytical evaluation using an HIV-1 secondary standard yielded limits of detection of 514, 710, and 1,090 HIV RNA copies/ml for EDTA plasma, whole blood, and DBS, respectively. The precision and reproducibility of HIV-1 detection was equivalent for DBS and whole blood. Inclusivity was demonstrated for a reference panel of HIV-1 subtypes A to N. A clinical evaluation of the Cobas AmpliPrep/Cobas TaqMan HIV-1 Qual test was performed at a center for routine diagnostics in Johannesburg, South Africa, using 1,013 clinical specimens from HIV-1 exposed children. The Amplicor HIV-1 DNA test v1.5 with the MagNApure DNA isolation procedure was used as the reference method. A total of 995 valid results for whole blood with both methods yielded 691 and 303 concordant negative and positive results for the Cobas AmpliPrep/Cobas TaqMan HIV-1 Qual test, respectively. For the 800 valid DBS specimen results, 495 and 300 concordant negative and positive results were obtained, respectively. The resulting clinical specificities and sensitivities of the new test were 100% and 99.7% for whole blood and DBS, respectively. The new test was characterized by its robustness, enhanced automation, and improved sample throughput. The Cobas AmpliPrep/Cobas TaqMan HIV-1 Qual test will support early, reliable diagnosis of HIV in children in routine laboratory settings.

* Corresponding author. Mailing address: 7 York Rd. Parktown, Johannesburg 2000, South Africa. Phone: 27-11-489-8505. Fax: 27-11-484-5812. E-mail: wendy.stevens{at}nhls.ac.za

{triangledown} Published ahead of print on 15 October 2008.

Journal of Clinical Microbiology, December 2008, p. 3941-3945, Vol. 46, No. 12
0095-1137/08/$08.00+0     doi:10.1128/JCM.00754-08
Copyright © 2008, American Society for Microbiology. All Rights Reserved.



This article has been cited by other articles:

  • Stevens, W. S., Noble, L., Berrie, L., Sarang, S., Scott, L. E. (2009). Ultra-High-Throughput, Automated Nucleic Acid Detection of Human Immunodeficiency Virus (HIV) for Infant Infection Diagnosis Using the Gen-Probe Aptima HIV-1 Screening Assay. J. Clin. Microbiol. 47: 2465-2469 [Abstract] [Full Text]  


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