Efficacy of Pooled Serum Internal Quality Control in Comparison with Commercial Internal Quality Control in Clinical Biochemistry Laboratory

Abstract

Introduction With increasing automation in clinical laboratories, the requirements for quality control (QC) material have greatly increased in order to monitor performance. The constant use of commercial control material is not economically feasible for many countries because of nonavailability or the high-cost of those materials. Therefore, preparation and use of in-house QC serum will be a very cost-effective measure with respect to laboratory needs. Materials and Methods In-house internal quality control from leftover serum samples of master health checkup subjects, which have been screened negative for HIV, HCV and HBsAg antibodies was pooled in a glass jar with ethanediol as preservative and kept in deep freezer at − 20°C. From the pooled serum, 100 microliter thirty aliquots were prepared. Every day along with commercial internal QC (IQC), one aliquot of pooled serum was analyzed for 30 days for the following parameters: plasma glucose, blood urea, serum creatinine, total cholesterol, triglycerides (TGL), high-density lipoprotein, calcium, total protein, albumin, total bilirubin, AST, ALT, ALP, amylase. After getting 30 values for each parameter, mean, standard deviation (SD) and CV% were calculated for both IQC commercial sample and pooled serum sample. Results The mean, SD, and CV% of glucose, cholesterol, TGL, calcium, alanine aminotransaminase (ALT), aspartate aminotransferase (AST), amylase, and alkaline phosphatase (ALP) were statistically significant between pooled serum and commercial QC. Conclusion In-house QC prepared from pooled serum is better than commercial internal QC. The biochemical parameters were stable in pooled serum due to less matrix effect; also, variation was less in pooled serum IQC.

Validation of the efficacy of pooled serum for serum glucose inhouse quality control material in comparison with commercial internal quality control in clinical chemistry laboratory

“…This study demonstrated significant stability in in-house quality control material stored at −20 °C to −30 °C over eight months, evidenced by consistently lower variability in glucose measurements compared to other storage temperatures. These findings align with previously published data by Sweta et al [ 27 ], Eliezer et al [ 28 ], Andrea et al [ 29 ], and Berhanu et al [ 30 ], solidifying the potential of frozen storage for maintaining QC material integrity. The use of in-house pooled serum, prepared separately, has been identified as a viable alternative to conventional control materials in developing countries.…”

Efficacy of In-House Quality Control Material Compared to Commercially Available Quality Control for Thyroid Hormone

“…Khatri et al 16 has shown in their study by using the patient sample that the reliability and validity of test reports will be better when compared to commercial quality control. Kulkarni S et al 17 in their study reported that in house pooled quality control efficacy is better than commercial quality control. Hence in our study, we found that in-house QC can be used for hormone assay also.…”

Comparison between Pooled Sera and Coomercial Serum on the Accuracy of Triglyceride Assessment

“…Meanwhile, research by Haile B et al (2020) states that pooled sera is a good substitute for commercial serum, especially for developing countries. The same thing was also expressed by Kulkarni, Pierre & Kaliaperumal (2020), that internal Quality Control (QC) made from collected sera is better than commercial internal QC. Therefore, laboratory examination plays an important role in establishing a diagnosis, especially accuracy in triglyceride examination.…”