A systematic review and meta-analysis on efficacy of pooled serum versus commercial serum internal quality control in clinical biochemistry laboratory

Background: Internal Quality Control (IQC) is a critical operation that includes discovering analytical flaws during patient sample analysis to enhance the accuracy and reliability of test results and improve patient care. Scarcity and exorbitant expense of commercial IQC material disadvantage many developing nations. Pooled serum can be a potential alternate for IQC material. The study's goal was to assess the effectiveness of pooled serum and commercial IQC materials in clinical laboratory. Material and Methods: A comprehensive search was conducted for data published in hospital settings between 2019 and June 2024 using data sources like Cochrane, PubMed, and Google scholar. The published articles selected were all pooled serum compared with commercial IQC in terms of efficacy, stability & cost effectiveness. Studies with incomplete data for meta-analysis were excluded. The data extraction was done as per pre-established checklist. RevMan 5.4 software was used to analyse the odds ratio for the coefficient of variation of pooled serum and commercial IQC. Results: Seven relevant publications were included in meta-analysis that compared the biochemical parameters of creatinine, urea, glucose, aspartate transaminase, triglyceride, alanine transaminase, total protein, total bilirubin, Alkaline Phosphatase (ALP), albumin, cholesterol, albumin, cholesterol, and calcium between pooled serum and commercial IQC. Apart from ALP, which significantly affected IQC (95% CI 0.10-0.40, P = 0.03) with a p value < 0.00001, there was no statistically significant difference between pooled serum and commercial serum parameters, and a significant Q statistic showed the absence of heterogeneity (I = 0%). Conclusion: Our study found that the pooled serum performed better than commercial IQC in clinical biochemistry laboratory and also showed that in-house pooled serum had more stable biochemical characteristics than commercial IQC material.