EVALUATION OF POLYMERASE CHAIN REACTION (PCR) KITS
Last updated: 29 April 2021
As the National Reference Laboratory for Emerging and Re-Emerging Infectious Diseases (NRL-EREID), the Research Institute for Tropical Medicine (RITM) is mandated to perform verification of infectious disease test kits. In April 2020, RITM announced that it can evaluate PCR test kits for SARS-CoV-2, as part of its response to the COVID-19 pandemic.
The evaluation procedures performed at RITM serve to: (1) verify manufacturer claims for assay performance, using the detection system/s available within its evaluation laboratories, (2) determine clinical or diagnostic sensitivity and specificity.
RITM results for assay performance evaluation may guide end-user laboratories in selecting assays to be employed within their respective laboratories, in addition to other considerations, such as the assay’s target genes, compatibility with existing laboratory equipment, approval of regulatory bodies, cost-effectiveness and other laboratory adoption requirements. End-user laboratories are still advised to perform their own verification, prior to assay adoption for diagnostic testing, as the testing conditions (instruments, other reagents, consumables, practices, etc) may vary from that of RITM’s at the time of evaluation.
Read more about the guidelines on the evaluation of in vitro diagnostic medical devices and other related laboratory diagnostic supplies for COVID-19 here.
Performance evaluation involves comparison of the assay under evaluation and a reference assay.
The panel consists of nasopharyngeal and oropharyngeal swabs of known SARS-CoV-2 RT qPCR results, of sufficient volume for further testing and appropriately stored in -800C. A minimum of 30 positives and 30 negatives are typically included in each sample panel.
Extraction of RNA material from sample panels is carried out using either commercially available: 1) spin column-based extraction kits or 2) magnetic bead-based extraction kits.
For PCR kits to be used in COVID-19 testing, the World Health Organization recommends a clinical sensitivity of ≥95% and specificity of ≥99%.
For PCR kits to be procured by the DOH, the HTAC recommends a clinical sensitivity and specificity of >99%. This standard metric is explained in depth in Rapid Review: SARS-COV-2 RT PCR Test Kits for the Diagnosis of COVID-19 Cases published by HTAC in May 2020.
The Health Technology Assessment Council (HTAC) is an independent advisory body with the overall role of providing guidance to the Department of Health (DOH) and the Philippine Health Insurance Corporation (PhilHealth) on the coverage of health interventions and technologies to be funded by the government.
|#||PCR Kit||Manufacturer||Sensitivity (95% CI)||Specificity (95% CI)||Date Performed|
|1||A*STAR FORTITUDE KIT 2.0 COVID19 RT-PCR TEST||Accelerate Technologies PTE||100% (88.40-100%)||100% (88.40-100%)||April 01-02|
|2||Primerdesign Ltd COVID19 Genesig® Real-Time PCR Assay||Primerdesign LTD||96.67% (82.78-99.9%)||100% (88.40-100%)||April 15-16|
|3||Multiple Realtime PCR kit for detection of 2019-nCoV (Beijing Applied Biological Technologies Xabt)||Beijing Applied Biological Technologies Co, LTD||100% (88.4-100%)||100% (88.40-100%)||April 16-17|
|4||GenAmplify™ Corona Virus Disease 2019 (COVID19) rRT-PCR Detection Kit||Manila HealthTek Inc.||78.95% (54.43-93.95)||100% (84.56-100%)||April 02-21|
|5||DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection Kit||Solgent Co, LTD||100% (88.43 to 100%)||93.33% (77.93 to 99.18%)||April25-26|
|6||Allplex™ 2019-nCoV Assay||Seegene Inc.||100% (88.43 to 100%)||100% (88.43 to 100%)||April 29-30|
|7||Detection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA (PCR-Fluorescence Probing)||Da An Gene Co. Ltd of Sun Yat-sen University||100% (88.43 to 100%)||100% (88.43 to 100%)||May 04-05|
|8||abTES™ COVID-19 qPCR I Kit (v1.0)||AIT Biotech PTE, LTD||100% (88.43 to 100%)||100% (88.43 to 100%)||May 07-08|
|9||Genefinder COVID-19 Plus RealAmp Kit||Osang Healthcare||100% (88.43 to 100%)||100% (88.43 to 100%)||May 24-25|
|10||BGI Real-Time PCR fluorescent RT-PCR Kit for detecting 2019-nCoV||BGI Europe A/S||100% (88.78% to 100%)||100% (88.78% to 100%)||May 23-29|
|11||GenAmplify Corona Virus Disease-2019 (COVID-19) rRT-PCR Detection Kit ver2.0||Manila HealthTek Inc.||88.37% (74.92%to 96.11%)||96.88% (83.78% o 99.92%)||June 13-15|
|12||MACCURA SARS-CoV-2 Fluorescent PCR||Maccura Biotechnology Co., Ltd., Chengdu, PRC||96.23% (87.02 to 99.54%)||100% (88.43% to 100%)||June 27 – July 1|
|13||TaqPath COVID-19 Combo Kit (Multiplex real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2||Thermo Fisher Scientific, Applied Biosystems||100% (92.45% to 100%)||100% (88.43% to 100%)||July 8-20|
|14||Sansure Bioteh Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)||Sansure Biotech||100% (92.45% to 100%)||100%(88.43% to 100%)||July 22-24|
|15||ProTect™ COVID-19 RT-qPCR Kit||JN Medsys, Singapore||100% (88.43% to 100%)||100% (88.43% to 100%)||September 1-4|
|16||Standard M nCoV Real-Time Detection Kit||SD Biosensor||100% (88.43% to 100%)||100% (88.43% to 100%)||September 7-11|
|17||Sentinel STAT-NAT® COVID-19 MULTI||Sentinel Diagnostics||73.68% (60.34% to 84.46%)||100% (89.11% to 100%)||September 14-21|
|18||PowerChek 2019-nCoV Real-time PCR Kit||Kogene Biotech Co.||98.31% (90.91% to 99.96%)||100% (88.43% to 100%)||October 6-19|
|19||FTD SARS-CoV-2 (FTD-114-96)||Siemens, Healthineers Company||100% (93.94% to 100%)||100% (88.43% to 100%)||October 6 - 14|
|20||2019-Novel Coronavirus (ORF1ab, E & N genes) nucleic acid test kit (Fluorescent Probe-|
based real-time PCR assay)
|Jiangsu Mole Bioscience Co. Ltd, Jiangsu Province China||79.31%||100%||Nov 22 - Dec 21, 2020|
|21||2019-Novel Coronavirus (ORF1ab, E & N genes) nucleic acid test kit (Fluorescent Probe-|
based real-time PCR assay) - Re-analysis using new IFU
|Jiangsu Mole Bioscience Co. Ltd, Jiangsu Province China||87.93% (76.70% to 95.01%)||100% (88.43% to 100%)||February 1- 3, 2021|
|22||A+CheQ COVID-19 High Speed RT-qPCR Detection Kit,||AMSBIO, Seoul, Republic of Korea||48.28% (34.95% to 61.78%)||100% (88.43% to 100%)||December 11-21, 2020|
|23||Wantai SARS-CoV-2 RT-PCT Kit Ref. No. WS-1248||Beijing Wantai Biological Pharmacy Enterprise Co., Ltd||100% (93.94% to 100%)||100% (88.06% to 100%)||Feb 3 - 16, 2021|
|24||Virella SARS-COV-2 seqc real-time RT-PCR Kit ref. no. G01128-96,||Gerbion GmbH & Co. KG. Remsstr. 1, 70806 Kornwestheim, Germany||84.75% (73.01% to 92.78%)||100% (88.06% to 100%)||Feb 3 - 16, 2021|
|25||LabGun™ COVID-19 RT-PCR Kit (REF CV9032B)||Labgenomics Co. Ltd, Gyeonggi-do, Korea 13488||96.55% (88.09% to 99.58%)||100% (88.43% to 100.00%)||Feb 22 - Mar 4, 2021|
|26||GenePro SARS-CoV-2 Test (REF CV002)||Gencurix, Guro-gu, Seoul, Korea||96.55% (88.09% to 99.58%)||100% (88.43% to 100.00%)||Feb 22 - Mar 4, 2021|
|27||Zybio SARS-CoV-2 Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) (REF: CoV2-32)||Zybio Inc., China||100% (94.04% to 100%)||100% (88.43% to 100.00%)||Mar 3 - Mar 9, 2021|
|28||CWBio Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing)||CWBio, China||91.38% (81.02% to 97.14%)||100% (87.23% to 100.00%)||Mar 30 - Apr 1, 2021|
|29||BGI Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 (updated evaluation)||BGI Genomics Co. Ltd., Shenzhen, China||96.49% (87.89% to 99.57%)||100% (86.28% to 100.00%)||April 20-27, 2021|
Results of RITM evaluations do not, in any way or form, represent a Certificate of Product Registration or Certificate of Authorization issued by the Philippine Food and Drug Administration (FDA).
The Institute is making this information available for public good and does not serve to endorse companies, manufacturers, or product brands for commercial purposes.