Indian Journal of Microbiology Research


Is commercial control necessary as a third party internal control for HIV – antibody ELISA testing? A comparative study in NABL accredited laboratory


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Author Details: RV Shinde, RV Mohite, AR Shinde, ST Mohite, GS Karande

Volume : 4

Issue : 2

Online ISSN : 2394-5478

Print ISSN : 2394-546X

Article First Page : 144

Article End Page : 149


Abstract

Aims & Objectives: To assess and compare the feasibility, availability, affordability, stability of In-house and commercial third party internal control of HIV antibody ELISA test.
Methods: A comparative study was conducted in NABL Accredited Diagnostic Laboratory at Krishna Institute of Medical Sciences Karad during June 2014 to July 2016. Sample size includes total of 457 ELISA tests which were carried out on 11425 patients along with internal, external commercial and in-house control as per NACO guidelines. Descriptive and inferential statistical tests were applied to find out significant difference between in-house and commercial control.
Results: There is significant difference in mean values of positive kit control and commercial positive control (p<0.05). There is also significant difference observed in mean values of commercial positive control and in-house positive control (p<0.05). The coefficient variance of positive in -house control is better (3.32) than commercial positive control (4.60) which indicates, in-house control is more precise than commercial control. The kit cut off values remains constant throughout the month indicates best technical competence, less environmental influences and reagent stability. The average cost of screening for HIV with ELISA and in-house control was Rs. 57/ per person.
Conclusion: There is no significant difference in mean values of positive kit control and in-house positive control, the diagnostic cost, feasibility and percentage CV% is better observed in in-house control as compared to commercial control indicating in-house control could be considered as third party internal control for HIV antibody ELISA test.

Keywords:
In-house control, Third party internal controls, Commercial controls, ELISA test