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

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....

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Bibliographic Details
Published in:Journal of Clinical Microbiology 2009-08, Vol.47 (8), p.2465-2469
Main Authors: Stevens, Wendy S, Noble, Lara, Berrie, Leigh, Sarang, Somaya, Scott, Lesley E
Format: Article
Language:English
Subjects:
Automation
Biological and medical sciences
Blood - virology
Fundamental and applied biological sciences. Psychology
HIV Infections - diagnosis
HIV Infections - virology
HIV-1 - genetics
HIV-1 - isolation & purification
Human immunodeficiency virus 1
Human viral diseases
Humans
Infant
Infectious diseases
Mass Screening - methods
Medical sciences
Microbiology
Miscellaneous
Molecular Diagnostic Techniques - methods
RNA, Viral - genetics
Sensitivity and Specificity
South Africa
Viral diseases
Viral diseases of the lymphoid tissue and the blood. Aids
Virology
Virology - methods
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Summary: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.
ISSN:0095-1137
1098-660X
DOI:10.1128/JCM.00317-09