ASSESSMENT OF COMPARISONS BETWEEN REALTIME PCR DEVICES USED IN THE QUALITY OF DIAGNOSTIC PRODUCTS

Abstract

Diagnostic kits based on Realtime PCR assay are commonly used in laboratory testing. A equipment, chemicals, and other items were necessary to prepare Realtime PCR experiments. Today, there are many types of Realtime PCR machine, which differ in the amplification hardware and the fluorogenic detections. As a result, the outcome of the same exam may differ depending on the system. The validity of molecular diagnostic tests may be impacted by this oscillation. This study evaluates the equipment similarities of 04 Realtime PCR systems being used at the National Institute for Control of Vaccines and Medical Biologicals (NICVB) including ABI7500; Realtime PCR CFX96 Touch Bio- Rad; abCyclerQ (AIT biotech) and QuantStudio^TM5.The study was carried out with the aim of comparing the results of the detection limit on 04 different real-time PCR systems on the same standard samples and biological chemicals. Methods and results were calculated according to the standard procedure of the Department of Medical Biologicals, NICVB.The LOD results of 04 equipment systems are 5.2 RNA copies/reaction (95%CI: 3.3-8.0 RNA copies/reaction), 10.77 RNA copies/reaction (95% CI: 3.3-8.0 RNA copies/reaction), respectively. CI: 7.62-15.24 RNA copies/reaction), 14.86 RNA copies/reaction (95% CI: 10.71-20.64 RNA copies/reaction), 10.04 RNA copies/reaction response (95%CI: 7.06-14.30 RNA copies/reaction). The LOD of 04 Realtime devices is in the range of 1-3xLOD compared to the reference LOD. Through the research results, it shows that 04 real-time PCR equipment systems give similar results. Therefore, it is possible to use interchangeably in 04 ABI7500 equipment systems; QuantStudioTM5; Realtime PCR system CFX96 Touch Bio-Rad and abCyclerQ (AIT biotech) in evaluating the quality of diagnostic biological products using Realtime PCR technique.