PERFORMANCE OF COBAS 8000 : HOW TO DETERMINE

 

Introduction

The precision of laboratory results is important to help clinicians to diagnose and to monitor the patient treatment. The automated analyzer is used for analysis of the patient samples for routine chemistry and urine tests, immunology and immunoassay. The instrument must be precise to deliver the patient results. This is very important in patient management.

METHODOLOGY

PRELIMANARI PRECISION

·         Level 1 and level 2 quality control recommended by manufacturer were run triplicate per day for five day.

·         The mean, variance, standard deviation and coefficient variation experiment were calculated for repeatable and intermediate.

·         The repeatable and intermediate coefficient variation were compared with the repeatable and intermediate coefficient variation manufacturer followed by The Clinical Laboratory Standard Institute (CLSI EP 10).

If unacceptable for both or other one perform ,verification precision

 

VERIFICATION PRECISION

 ·         The standard deviation for repeatable manufacturer (SD_mnf) and/or standard deviation

       intermediate manufacturer(TSD_mnf) were calculated based on mean experiment and  

       coefficient variation manufacturer.

·         The standard deviation for repeatable and/or intermediated manufacturer were compared with the standard deviation experiment (repeatable and/or intermediate where applicable) followed by The Clinical Laboratory Standard Institute (CLSI EP 15)

·         If unacceptable, the troubleshooting were perform and repeat the preliminary precision

 

Results

The achievement of the analyzer for routine chemistry and urine tests, immunology and immunoassay for the level 1 QC based on the coefficient variation manufacturer claim were 54% for repeatable and 78% for intermediate at the preliminary precision. 46% of the level 1 QC for repeatable and 22 %  of the intermediate were acceptable at the verification precision.

For the level 2 QC results, the performance based on the coefficient variation of manufacturer claim is 56% and 77% for intermediate.  Therefore, 44% of the;level; 2 QC for repeatable and 23% of the intermediate were acceptable based on the verification precision.

Conclusion

Based on the studies, all the results of the routine chemistry and  urine tests, immunology and immunoassay are precised for patient management as long as maintenance schedule, the procedure of the pre-analytical as sample collection, transportation, time receiving and processing of samples are followed.