PRODUCTION OF LIOPHILIZED QUALITY CONTROL SAMPLES FOR SEVERAL CLINICAL CHEMISTRY TEST

Nguyen Quynh Giao, Dang Quang Huy, Pham Thi Huong Trang, Dang Thi Ngoc Dung, Trinh Thi Phuong Dung

Tóm tắt


An essential part of medical laboratory quality assurance is statistical quality control (SQC) which requires the laboratory to analyse quality control materials. Our research focused on lyophilized quality control material that can be produced using materials from laboratory. Plasma samples, anticoagulated by heparin, that had common clinical chemistry parameters including creatinine, total cholesterol and AST, were collected from the Department of Medical Laboratory  at the Hanoi Medical University Hospital. All parameters were within the normal reportable range. The samples were lyophilized and tested for homogeneity and stability. Homogeneity and stability testing results for lyophilized and frozen control samples for creatinine, total cholesterol and AST showed no significant difference in 20 days across six assessment time points (p > 0.05). The results also indicated that despite the acceptable stability performance within 20 days. The procedure for production of lyophilized quality control material for several clinical chemistry tests showed initial success.

 


Từ khóa


Statistical quality control, quality control material, homogeneity, stabili

Toàn văn:

PDF

Tài liệu tham khảo


Ngo Thin Duy, Trinh Binh, Pham Duong Tuan, Do Phan Trung (2007). Research on development of fresh plasma lyophilization for clinical treatment using LY3-TTE/DM8 lyophilizer. Journal of Medical Research, 49(3).

ISO 15328 (2015). Statistical methods for use in proficiency testing by interlaboratory comparison.

Thompson M., Stephen LR Ellison., Wood R (2006). The international harmonized protocol for the proficiency testing of analytical chemistry laboratories (IUPAC Technical Report). Pure and Applied Chemistry, 78(1), 145 - 196.

ISO Guide 35 (2006). Reference materials -General and statistical principles for certification.

Jamtsho R (2013). Stability of Lyophilized Human Serum for Use as Quality Control Material in Bhutan. Indian J Clin Biochem, 28(4), 418 - 421.

Maurukas J (1978). Process for preparing biological compositions for use as reference controls in diagnostic analyses

Divya PD., Jayavardhanan KK (2010). Effect of Temperature and storage time on Hepatobiliary enzyme activities in Goat serum. Veterinary World, 3(6), 277 - 279.