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    Mar 03, 2021
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    Opportunities to improve storage and transportation of blood specimens for CD4 testing in a rural district in Zimbabwe using BD vacutainer CD4 stabilization tubes: a stability and diagnostic accuracy study

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    Fajardo et al - 2014 - Opportu ...
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    Authors
    Fajardo, Emmanuel
    Metcalf, Carol
    Mbofana, Elton
    van Vyve, Charlotte
    Munyaradzi, Dhodho
    Simons, Sandra
    Kuhudzayi, Misheck
    Bygrave, Helen
    Issue Date
    2014-10-22
    
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    Journal
    BMC Infectious Diseases
    Abstract
    BackgroundCD4+ T-cell testing of blood specimens collected in standard EDTA Vacutainer tubes and transported at ambient temperature, must be completed within 48 hours with the BD FACSCount¿ flow cytometer, restricting specimen collection in remote clinics with no on-site testing and limited specimen transport services. We conducted a study in Buhera District, Zimbabwe, to assess the stability and accuracy of CD4+ T-cell results of samples collected in Stabilization Tubes (ST) and stored at ambient temperature for varying time periods.MethodsPaired EDTA and ST samples were collected from 51 HIV-positive patients aged 18 years and older. CD4+ T-cell testing was done on arrival in the laboratory (Day 0). ST samples were retested on Days 3, 5, and 7. Nineteen ST samples were stored for an additional week and retested on Day 14.ResultsThere was a strong correlation between absolute CD4+ T-cell counts measured in the EDTA Day 0 reference sample and Day 7 ST sample (Spearman¿s rho: 0.9778; mean difference: ¿4.9 cells/¿L and limits of agreement (LOA): 98.5 and 88.7 cells/¿L); and the reference sample and Day 14 ST sample (Spearman¿s rho: 0.9632; mean difference 5.1 cells/¿L and LOA: ¿99.6 and 109.8 cells/¿L. Using a 350 cells/¿L threshold, the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were all 100% on Day 7, and 83.3%, 100%, 100% and 92.9% on Day 14. Using a 500 cells/¿L threshold, the sensitivity, specificity, PPV and NVP were 100%, 88.5%, 88.5% and 100% on Day 7 and 88.9%, 80.0%, 80.0% and 88.9% on Day 14.ConclusionsCD4 ST can be used and stored up to 7 days as a reliable alternative to standard EDTA tubes in settings where CD4+ T-cell testing within 48 hours is not feasible. Despite the small sample size, results suggest that ST may be stored up to 14 days at room temperature for CD4 testing, without compromising accuracy. However, further studies with larger sample sizes are needed to confirm this preliminary finding.
    Publisher
    BioMed Central
    URI
    http://hdl.handle.net/10144/334902
    DOI
    10.1186/s12879-014-0553-9
    PubMed ID
    25330812
    Language
    en
    ISSN
    1471-2334
    ae974a485f413a2113503eed53cd6c53
    10.1186/s12879-014-0553-9
    Scopus Count
    Collections
    HIV/AIDS

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