SARS-COV-2 Polymerase Chain Reaction (PCR)

EVALUATION OF POLYMERASE CHAIN REACTION (PCR) KITS
Last updated: 03 March 2020

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.

METHODS
Performance evaluation involves comparison of the assay under evaluation and a reference assay.

The panel are comprised 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 are carried out using either commercially available: 1) spin column-based extraction kits or 2) magnetic bead-based extraction kits.

STANDARDS
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.

For PCR kits to be used in COVID-19 testing, 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.

results
PCR Kit Manufacturer Lot Number Sensitivity Specificity Date Performed
Virella SARS-COV-2 seqc real-time RT-PCR Kit ref. no. G01128-96, Gerbion GmbH & Co. KG. Remsstr. 1, 70806 Kornwestheim, Germany Lot no. VCOVs111120, VCOVs012220 84.75% (95% CI: 73.01% to 92.78%) 100% (95% CI: 88.06% to 100%) Feb 3 – 16, 2021
Wantai SARS-CoV-2 RT-PCT Kit Ref. No. WS-1248 Beijing Wantai Biological Pharmacy Enterprise Co., Ltd Lot. No. nCOVp20201110 100% (95% CI: 93.94% to 100%) 100% (95% CI: 88.06% to 100%) Feb 3 – 16, 2021
A+CheQ COVID-19 High Speed RT-qPCR Detection Kit, AMSBIO, Seoul, Republic of Korea 20O08A/ 20N19A 48.28%
(95% CI: 34.95% to 61.78%)
100%
(95% CI: 88.43% to 100%)
December 11-21, 2020
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 Lot No. 20200818/20201015 79.31%
(95% CI: 66.65% to 88.83%)
100%
(95% CI: 88.43% to 100%)
November 22 – December 21, 2020
FTD SARS-CoV-2 (FTD-114-96) Siemens, Healthineers Company SC20-32-05, SC20-96-08 100%
(95% CI: 93.94% to 100%)
100%
(95% CI: 88.43% to 100%)
October 6 – 14
PowerChek 2019-nCoV Real-time PCR Kit Kogene Biotech Co. 200801 98.31%
(95% CI: 90.91% to 99.96%)
100%
(95% CI: 88.43% to 100%)
October 6-19
Sentinel STAT-NAT® COVID-19 MULTI Sentinel Diagnostics 00477 73.68%
(95% CI: 60.34% to 84.46%)
100%
(95% CI: 89.11% to 100%)
September 14-21
Standard M nCoV Real-Time Detection Kit SD Biosensor MNCO0120011 100%
(95% CI: 88.43% to 100%)
100%
(95% CI: 88.43% to 100%)
September 7-11
ProTect™ COVID-19 RT-qPCR Kit JN Medsys, Singapore RD202004-03 100%
(95% CI: 88.43% to 100%)
100%
(95% CI: 88.43% to 100%)
September 1-4
Sansure Bioteh Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) Sansure Biotech 2020063 100%
(95% CI: 92.45% to 100%)
100%
(95% CI: 88.43% to 100%)
July 22-24
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 2220319, 2004020 100%
(95% CI: 92.45% to 100%)
100%
(95% CI: 88.43% to 100%)
July 8-20
MACCURA SARS-CoV-2 Fluorescent PCR Maccura Biotechnology Co., Ltd., Chengdu, PRC 0420151 96.23%
(95% CI: 87.02 to 99.54%)
100%
(95% CI:88.43% to 100%)
June 27 – July 1
GenAmplify Corona Virus Disease-2019 (COVID-19) rRT-PCR Detection Kit ver2.0 Manila HealthTek Inc. PO2020-03014 88.37%
(95% CI: 74.92%to 96.11%)
96.88%
(95% CI: 83.78% o 99.92%)
June 13-15
BGI Real-Time PCR fluorescent RT-PCR Kit for detecting 2019-nCoV BGI Europe A/S 6220200432 100%
(95% CI: 88.78% to 100%)
100%
(95% CI: 88.78% to 100%)
May 23-29
Genefinder COVID-19 Plus RealAmp Kit Osang Healthcare 2003-R45-02 100%
(95% Cl: 88.43 to 100%)
100%
(95% Cl: 88.43 to 100%)
May 24-25
abTES™ COVID-19 qPCR I Kit (v1.0) AIT Biotech PTE, LTD L141-11 100%
(95% Cl: 88.43 to 100%)
100%
(95% Cl: 88.43 to 100%)
May 07-08
Detection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA (PCR-Fluorescence Probing) Da An Gene Co. Ltd of Sun Yat-sen University 2020007 100%
(95% Cl: 88.43 to 100%)
100%
(95% Cl: 88.43 to 100%)
May 04-05
Allplex™ 2019-nCoV Assay Seegene Inc. RP4520C24 100%
(95% Cl: 88.43 to 100%)
100%
(95% Cl: 88.43 to 100%)
April 29-30
DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection Kit Solgent Co, LTD SO76EZ 100%
(95% Cl: 88.43 to 100%)
93.33%
(95% Cl: 77.93 to 99.18%)
April25-26
GenAmplify™ Corona Virus Disease 2019 (COVID19) rRT-PCR Detection Kit Manila HealthTek Inc. L2020-COVID002 78.95%
(95%Cl: 54.43-93.95)
100%
(95% Cl: 84.56-100%)
April 02-21
Multiple Realtime PCR kit for detection of 2019-nCoV (Beijing Applied Biological Technologies Xabt) Beijing Applied Biological Technologies Co, LTD 20200308 100%
(95% Cl: 88.4-100%)
100%
(95% Cl: 88.40-100%)
April 16-17
Primerdesign Ltd COVID19 Genesig® Real-Time PCR Assay Primerdesign LTD JN-02780-0005 96.67%
(95% Cl: 82.78-99.9%)
100%
(95% Cl: 88.40-100%)
April 15-16
A*STAR FORTITUDE KIT 2.0 COVID19 RT-PCR TEST Accelerate Technologies PTE 200207R 100%
(95% Cl: 88.40-100%)
100%
(95% Cl: 88.40-100%)
April 01-02

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.