EC Microbiology

Introduction: The sensitivity and specificity of a test is key in diagnostic accuracy, performance assay and analytical quality management. It is a fulcrum in which quality control (QC) procedures viz: quality design and planning rest. NIMR-made electrophoresis machines for the determination of the Haemoglobin (Hb) phenotype were tested against the standard (imported/foreign electrophoretic machines used in evaluation centres for routine work). The objective was to test the validity, usefulness and application in line with the Standards for Reporting of Diagnostic Accuracy Studies (STARD) protocol. STARD is a protocol that seeks to improve the completeness and transparency of reports of diagnostic accuracy studies in testing new equipment, fabricated equipment, new or modified method, reagents and or test kits.

Methods: NIMR-made haemoglobin electrophoretic machines were sent to eight selected secondary and tertiary laboratory centres for validation using standard test protocol.

Results: The sensitivity and specificity congruence between foreign-made brands used by these centres and NIMR-made electrophoretic machine was 100%, while the time of separation of the bands was also better with the NIMR-made electrophoretic machine (6.69 minutes) compared to foreign-made brands (11.54 min) (P = 0.001) However, neatness of band separation, the accuracy of band separation, the consistency of band separation, the ease of use of machine and the percentage agreement were not significantly different.

Conclusion: This study shows a 100% diagnostic agreement in terms of sensitivity and specificity based on STARD guidelines.

Keywords: Validity; Diagnostic Accuracy; Performance; NIMR-Made Electrophoretic Machine; Sensitivity; Specificity

1. Adeyemo OA and Soboyejo OB. "Frequency distribution 0f ABO, RH blood groups and blood genotypes among the cell biology and genetics students of University of Lagos, Nigeria”. African Journal of Biotechnology 22 (2006): 2062-2065.
2. Egesie OJ., et al. “Prevalence of Sickle Cell Trait and Glucose 6 Phosphate Dehydrogenase Deficiency among Blood Donors in a Nigerian Tertiary Hospital”. African Journal of Biomedical Research 16 (2013): 143.
3. Cohen JF., et al. “STARD 2015 guidelines for reporting diagnostic accuracy studies: explanation and elaboration”. British Medical Journal 6 (2016): e012799.
4. Erhabor OO., et al. “Effects of falciparum malaria on the indices of anaemia among pregnant women in the Niger Delta of Nigeria”. Journal of Clinical Medicine and Research3 (2010): 035-041.
5. Organization World Health. "Protocol for the laboratory evaluation of HCV molecular assays”. WHO/EMP/RHT/PQT/2018 (2018): V 4.0.
6. JAC Kirkwood BR and Sterne. “Essential medical statistics”. Malden, Massachusetts, USA.: Blackwell Publishing Company (2003).
7. Pennap GR., et al. “Frequency Distribution of Hemoglobin Variants, ABO and Rhesus Blood Groups among Students of African Descent”. British Microbiology Research Journal2 (2011): 33-40.