Abstract
We conducted a systematic review of quantitative studies that evaluated the accuracy of nucleic acid amplification testing technologies (NAAT) compared their cost effectiveness and evaluated minipool NAAT against individual donor testing NAAT. PubMed, Cochrane and Google Scholar were used to identify relevant peerâreviewed journal articles published in English language between 1999 (when NAAT was introduced) and 2013. MeSH key words included: Human immunodeficiency virus OR HIV AND nucleic acid amplification techniques OR pooled NAAT AND blood donors. Additional filters include: minipool-NAAT and individual donor testing-NAAT. After screening for duplication and relevance, 50 out of 4,181 articles were selected. Thirty six (36) studies which included 5 review article, 5 retrospective cohort studies, 20 cross sectional studies, 2 statistical modeling’s, 2 national guidelines and 2 prospective cohort studies were further synthesized. Articles were further sub-divided into 8 groups based their focus area which includes: prevalence, clinical sensitivity of the assay, analytical sensitivity, test technology, testing algorithm, limit of detection and cost effectiveness. Four of six studies with pool sizes of 10 to 50 donor plasmas with standard centrifugation recorded a clinical sensitivity of 100% while the remaining two whose plasma pool size of 96 and128 had sensitivities of 92.3% and 95.3%, respectively. All four studies that focused on analytical sensitivity using different samples and controls, including cadaveric samples reported 100% analytical sensitivity using various pool sizes. We recommend minipool NAAT testing after running a third generation ELISA as highly sensitive and cost effective algorithm for low income countries.
Highlights
The prevalence of transfusion-transmissible infections (TTIs) in blood donations in developed countries is somewhat lower than in under-developed and developing nations
The 3rd generation HIV antibody enzyme linked immunosorbent assay (ELISA) tests increased the sensitivity of the assay by including the detection of anti-HIV IgM as well as IgG antibodies in serum or plasma samples and the 4th generation HIV antibody and p24 ELISA tests detect early or acute HIV infection by including detection of p24 antigen in plasma/serum samples
We reviewed the cost effectiveness of mini-pool nucleic acid amplification testing technologies (NAAT) against Individual donor NAAT, third generation ELISA, and fourth generation ELISA respectively
Summary
Background The prevalence of transfusion-transmissible infections (TTIs) in blood donations in developed countries is somewhat lower than in under-developed and developing nations. The prevalence of HIV in blood donations in high income countries is 0.003%, in comparison with 0.1% and 0.6% in middle and low income countries respectively [1]. This explains the difference in prevalence amongst eligible donors from these populations, the type of donors (such as voluntary nonrenumurated blood donors from low risk groups) and the effectiveness of donor selection mechanisms [1]. The 1st generation HIV antibody ELISA was designed using viral lysate to detect anti-HIV-1 IgG antibodies in plasma or serum samples. The 2nd generation HIV antibody ELISA tests used recombinant antigens to detect anti-HIV-1 and HIV-2 IgG antibodies in plasma or serum samples. The nucleic acid amplification tests are the most sensitive for the detection of acute HIV infection, after ruling out established HIV infections using HIV antibody detecting ELISA
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