| ABSTRACT
Polymerase chain reaction (PCR) methods are extensively used in diverse clinical laboratories due to high reliability, high sensitivity and productivity. The purpose of this validation is to transit the related cytomegalovirus (CMV) by qualitative PCR and CMV DNA quantitation by PCR assays from the ABI Prism 7900HT (ABI7900) using the Promega Protocol to the QuantStudio™ 12K Flex Real-Time PCR System (QuantStudio) using Protocol l. Limit of detections (LODs) of CMV in whole blood , plasma, serum, CSF, BAL, bone marrow, DBS, ocular fluid, saliva and urine were the same on both QuantStudio and ABI7900. In amniotic fluid, QuantStudio had a lower LOD than the ABI7900. The accuracy of QuantStudio had a 100% agreement with the ABI7900. The intra-run precision and inter-run precision were also comparable and less than 5% on both analyzers. Therefore, CMVPCR and CMV quantitation assays can be successfully performed using the QuantStudio. |