Background: Kit lot change in clinical biochemistry labs leads to variations in patient results. This study planned to identify variations during 60 reagent lot changes in our laboratory during the period from June 2018 to May 2019.
Methods: A statistical analysis was performed to identify the difference between patient samples results variations and QC results. The long term drift was analyzed using a regression test.
Results: There was a significant difference between the patient and QC results in 16.7% of reagent lot changes. Moreover, the extent of variation in QC results was 3.3%. No long-term drift was seen in three analytes which were studied using regression analysis.
Conclusions: Our results showed that, during reagent kit lot change, along with QC material, the patient samples should also be run in order to identify the variation. However, this practice is presently ignored by most of the laboratories. There was no accumulated effect in our laboratory due to reagent kit lot change.
Uvod: Promena setova reagenasa u biohemijskim laboratorijama na klinikama dovodi do varijacija u rezultatima pacijenata. Plan ovog istraživanja je bio da identifikuje varijacije u toku šezdeset promena setova reagenasa u našoj laboratoriji u periodu od juna 2018. godine do maja 2019. godine.
Metode: Izvršena je statistička analiza kako bi se identifikovala razlika između varijacija u rezultatima pacijenata i rezultata kontrole kvaliteta (QC). Dugoročne promene su analizirane pomoću regresijskih testova.
Rezultati: Otkrivena je značajna razlika u rezultatima pacijenata i kontrole kvaliteta u 16,7% promena setova reagenasa. Takođe, opseg varijacije u rezultatima kontrole kvaliteta bio je 3,3%. Nisu pronađene dugoročne promene u tri analita koja su analizirana regresijskim testovima.
Zaključak: Naši rezultati ukazuju na to da bi prilikom zamene setova reagenasa, pored materijala za kontrolu kvaliteta, trebalo testirati i uzorke pacijenata kako bi se identifikovale varijacije. Međutim, većina laboratorija ovaj postupak ne primenjuje. Nije pronađen dugoročni uticaj usled nagomilavanja varijacija prilikom promene setova reagenasa u našoj laboratoriji.
Keywords: NABL; clinical chemistry; long term drift; quality control; reagent lot change; short term variation.
2021 Vivek Ambade, Pratibha Misra, Yaongamphi Vashum, Mukul Sharma, Bhasker Mukherjee, Kapil Bhatia, Manoj Puliyath, Ponnaiah Rasu, Prakash Berthwal Indra, Madathan Kandi Sibin, published by CEON/CEES.