Evaluation of the stability of Cell Dyn® 16 tri LEVEL as a control material for laboratory external quality assessment scheme on hematology

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Abstract

The implementation of a laboratory test should always implement a laboratory quality control program, i.e internal quality control and external quality assessment. In an external quality assessment scheme, a control material that is stable over delivery until tested by the participating laboratory. In this study, we evaluated the stability of Cell Dyn 16 Tri Level (TL) control material at room temperature (26-32°C). stored in a transport vessel containing ice pack, and the precision and accuracy of the instrument Cell Dyn 1400. The control used was Cell Dyn 16 TL with low value (L), normal value (N) and high value (H). This study was done in the Clinical Pathology Department of FKUI-RSCM during February 2001 until May 2001. Control material was stored room in a transport vessel containing ice pack for 15 days, then analysed macroscopically, microscopically and evaluated for its stability. Test for precision and accuracy was done within run and for precision between day on Cell Dyn 1400. The result of this study showed a macroscopic change beginning on day 14 (L) day 12 (N) and day 15 (H). Microscopic change was observed on day 13 (L and N) and day 15 (H). Erythrocyte and hemoglobin level was stable until day 15. Changes in leukocyte was seen on day 14 (L), day 12 (N) and day 15 (H). Platelet showed instability on day 9 (L), day 10 (N and H). Mean erythrocyte volume was out of range on day 15 (L), but the N and H control was still stable. The precision and accuracy of Cell Dyn 1400 was in WHO recommended range. We concluded that the precision and accuracy of Cell Dyn 1400 is good. Cell Dyn 16 TL control material was stable until day 9, and its can be recommended to be used as a control material for external quality assessment scheme.

Original languageEnglish
Pages (from-to)115-123
Number of pages9
JournalSoutheast Asian Journal of Tropical Medicine and Public Health
Volume33
Issue numberSUPPL.2
Publication statusPublished - 1 Dec 2002

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