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Journal of Clinical Microbiology, August 2009, p. 2465-2469, Vol. 47, No. 8
0095-1137/09/$08.00+0     doi:10.1128/JCM.00317-09
Copyright © 2009, American Society for Microbiology. All Rights Reserved.

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{triangledown}

Wendy S. Stevens,1* Lara Noble,1 Leigh Berrie,2 Somaya Sarang,1 and Lesley E. Scott1

Department of Molecular Medicine and Haematology, University of the Witwatersrand, and National Health Laboratory Services, Johannesburg, South Africa,1 Ilex, SA, Johannesburg, South Africa2

Received 12 February 2009/ Returned for modification 24 April 2009/ Accepted 21 May 2009

The early diagnosis of human immunodeficiency virus (HIV) infection in infants is critical to ensure the initiation of treatment before significant immunological compromise. Each year an estimated 300,000 HIV-exposed infants in South Africa require access to tests for the diagnosis of HIV infection. Currently, testing is performed at several facilities by using PCR amplification of HIV DNA at 6 weeks of age by the use of dried blood spots (DBSs) and whole blood (WB). The Gen-Probe Aptima HIV type 1 (HIV-1) screening assay (the Aptima assay) is a qualitative nucleic acid test based on transcription-mediated amplification (TMA), a technology routinely used in blood banks in South Africa. The performance characteristics of Gen-Probe's TMA technology compared well to those of the Roche Amplicor HIV-1 DNA (version 1.5) assay. The sensitivity of the assay with WB and DBS samples was 100%, and the specificities were 99.4% and 99.5% for DBSs and WB, respectively. The detection of HIV by the Aptima assay at greater levels of dilution in samples negative by the comparator assay indicates an improvement in sensitivity by the use of the TMA technology. The ability to process 1,900 samples in a 24-h period on the Tigris instrument makes the Aptima assay an attractive option for high-volume, centralized laboratories.

* Corresponding author. Mailing address: Department of Molecular Medicine and Haematology, University of the Witwatersrand, 7 York Rd., Parktown, Johannesburg, 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 27 May 2009.

Journal of Clinical Microbiology, August 2009, p. 2465-2469, Vol. 47, No. 8
0095-1137/09/$08.00+0     doi:10.1128/JCM.00317-09
Copyright © 2009, American Society for Microbiology. All Rights Reserved.





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