EC Microbiology

Research Article Volume 18 Issue 12 - 2022

Validation of Diagnostic Accuracy and Performance of NIMR-made Electrophoretic Machine in Determination of Haemoglobin Phenotype in Nigeria

Nkiruka Nnonyelum Odunukwe1, Akwaowo Bassey Orok2, Jane Ogoamaka Okwuzu1*, Adeniyi Adeneye3, Aigbe Gregory Ohihoin1, Esther Ngozi Ohihoin1, Ngozi Mirabel Otuonye4, Anazoeze Madu5, Lateef Salawu6, Abubakar Umar Musa7, Olusolape Temilola Kayode8, Samuel Akindele9, Jamiu Opeyemi Sulaiman10, Olakigbe Abiodun Kanmi3 and Babatunde Lawal Salako1

1Clinical Sciences Department, NIMR, Nigeria

2Biochemistry Department, NIMR, Nigeria

3Public Health Department, NIMR, Nigeria

4Central Research Laboratory, NIMR, Nigeria

5Haematology Department, UNTH Enugu, Nigeria

6Haematology Department, OAUTH, Nigeria

7Haematology Department, UDUTH Sokoto, Northwest Nigeria, Nigeria

8Haematology Department, FMC Ebutte Meta Yaba Lagos, Nigeria

9Clinical Diagnostic Laboratory NIMR, Nigeria

10Ijede General Hospital, Nigeria

*Corresponding Author: Jane Ogoamaka Okwuzu, Clinical Sciences Department, Nigerian Institute of Medical Research (NIMR), Yaba Lagos, Nigeria.
Received: October 19, 2022; Published: November 08, 2022

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

Nkiruka Nnonyelum Odunukwe., et al. “Validation of Diagnostic Accuracy and Performance of NIMR-made Electrophoretic Machine in Determination of Haemoglobin Phenotype in Nigeria”. EC Microbiology  18.12 (2022): 02-08.