Diagnostic Performance Of Sars-cov-2 Real-time Polymerase Chain Reaction Testing Assays And Some Platforms Available In Ethiopia For The Diagnosis Of Coronavirus Diseases -2019.
Abstract rnBackground: Laboratory has a key role for the management of coronavirus disease-2019 (COVID-19).rnSince the outbreak reported, many commercial Nucleic Acid Testing (NAT) assays have been developedrnall over the world, and real-time PCR detection has been the routine and standard method. However, duernto a number of NAATs were rapidly developed and quickly applied to clinical testing, diagnosticrnperformance testing for different detection assays and PCR platforms should be considered. rnObjective: To assess the diagnostic performance of SARS-CoV-2 real time polymerase chain reactionrn(RT-PCR) testing assays and some platforms available in Ethiopia for the diagnosis of COVID-19 inrnEthiopian public health institute from December 1 to December 30/2020. rnMethods: Comparative experimental study was conducted to assess the performance of four PCR testingrnassays and platforms by using Composite reference standard (CRS) as a reference method in EthiopianrnPublic Health Institute at National HIV Reference laboratory from December 1 to 30/2020. Sample sizernwas determined based on WHO recommendation for method evaluation, 164 samples were selected byrnsystematic random Sampling technique. Selected samples were extracted manually by using QIAamp®rnviral RNA mini kit (QIAGEN GmbH, Hilden, Germany) and Abbott DNA sample preparation systemrn(Abbott Molecular Inc. des Plaines, IL, USA) for automated extraction. Amplification and detection wasrndone on Abbott m2000, Roche 4800 and ABI 7500 RT-PCR platforms. Finally, the data was entered,rncleared and analyzed by using SPSS version 23. Sensitivity, specificity, positive and negative percentrnagreement was analyzed and kappa Estimator was employed to determine the strength of agreement ofrneach method with CRS. rnResults: A total of 164 samples included in the study, out of these the rate of positive and negativernCOVID-19 test was 59.1% (97) and 40.9% (67) respectively in the CRS. Rate of positivity/negativityrnassays with respective platforms were comparatively similar with CRS (p>0.05). However, SansurernBiotech result was comparatively different with CRS (p