SARS-COV-2 PLATE-BASED PCR

EVALUATION OF POLYMERASE CHAIN REACTION (PCR) KITS
Last updated: 31 May 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.

METHODS

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.

RITM technical evaluation standards for SARS-COV-2 PCR kits

STANDARDS

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 KitManufacturerSensitivity (95% CI) Specificity (95% CI)Date Performed
1A*STAR FORTITUDE KIT 2.0 COVID19 RT-PCR TESTAccelerate Technologies PTE100% (88.40-100%)100% (88.40-100%)April 01-02
2Primerdesign Ltd COVID19 Genesig® Real-Time PCR AssayPrimerdesign LTD96.67% (82.78-99.9%)100% (88.40-100%)April 15-16
3Multiple Realtime PCR kit for detection of 2019-nCoV (Beijing Applied Biological Technologies Xabt)Beijing Applied Biological Technologies Co, LTD100% (88.4-100%)100% (88.40-100%)April 16-17
4GenAmplify™ Corona Virus Disease 2019 (COVID19) rRT-PCR Detection KitManila HealthTek Inc.78.95% (54.43-93.95)100% (84.56-100%)April 02-21
5DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection KitSolgent Co, LTD100% (88.43 to 100%)93.33% (77.93 to 99.18%)April25-26
6Allplex™ 2019-nCoV AssaySeegene Inc.100% (88.43 to 100%)100% (88.43 to 100%)April 29-30
7Detection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA (PCR-Fluorescence Probing)Da An Gene Co. Ltd of Sun Yat-sen University100% (88.43 to 100%)100% (88.43 to 100%)May 04-05
8abTES™ COVID-19 qPCR I Kit (v1.0)AIT Biotech PTE, LTD100% (88.43 to 100%)100% (88.43 to 100%)May 07-08
9Genefinder COVID-19 Plus RealAmp KitOsang Healthcare100% (88.43 to 100%)100% (88.43 to 100%)May 24-25
10BGI Real-Time PCR fluorescent RT-PCR Kit for detecting 2019-nCoVBGI Europe A/S100% (88.78% to 100%)100% (88.78% to 100%)May 23-29
11GenAmplify Corona Virus Disease-2019 (COVID-19) rRT-PCR Detection Kit ver2.0Manila HealthTek Inc.88.37% (74.92%to 96.11%)96.88% (83.78% o 99.92%)June 13-15
12MACCURA SARS-CoV-2 Fluorescent PCRMaccura Biotechnology Co., Ltd., Chengdu, PRC96.23% (87.02 to 99.54%)100% (88.43% to 100%)June 27 – July 1
13TaqPath COVID-19 Combo Kit (Multiplex real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2Thermo Fisher Scientific, Applied Biosystems100% (92.45% to 100%)100% (88.43% to 100%)July 8-20
14Sansure Bioteh Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)Sansure Biotech100% (92.45% to 100%)100%(88.43% to 100%)July 22-24
15ProTect™ COVID-19 RT-qPCR KitJN Medsys, Singapore100% (88.43% to 100%)100% (88.43% to 100%)September 1-4
16Standard M nCoV Real-Time Detection KitSD Biosensor100% (88.43% to 100%)100% (88.43% to 100%)September 7-11
17Sentinel STAT-NAT® COVID-19 MULTISentinel Diagnostics73.68% (60.34% to 84.46%)100% (89.11% to 100%)September 14-21
18PowerChek 2019-nCoV Real-time PCR KitKogene Biotech Co.98.31% (90.91% to 99.96%)100% (88.43% to 100%)October 6-19
19FTD SARS-CoV-2 (FTD-114-96)Siemens, Healthineers Company100% (93.94% to 100%)100% (88.43% to 100%)October 6 - 14
202019-Novel Coronavirus (ORF1ab, E & N genes) nucleic acid test kit (Fluorescent Probe-
based real-time PCR assay)
Jiangsu Mole Bioscience Co. Ltd, Jiangsu Province China79.31%100%Nov 22 - Dec 21, 2020
212019-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 China87.93% (76.70% to 95.01%)100% (88.43% to 100%)February 1- 3, 2021
22A+CheQ COVID-19 High Speed RT-qPCR Detection Kit,AMSBIO, Seoul, Republic of Korea48.28% (34.95% to 61.78%)100% (88.43% to 100%)December 11-21, 2020
23Wantai SARS-CoV-2 RT-PCT Kit Ref. No. WS-1248Beijing Wantai Biological Pharmacy Enterprise Co., Ltd100% (93.94% to 100%)100% (88.06% to 100%)Feb 3 - 16, 2021
24Virella SARS-COV-2 seqc real-time RT-PCR Kit ref. no. G01128-96,Gerbion GmbH & Co. KG. Remsstr. 1, 70806 Kornwestheim, Germany84.75% (73.01% to 92.78%)100% (88.06% to 100%)Feb 3 - 16, 2021
25LabGun™ COVID-19 RT-PCR Kit (REF CV9032B)Labgenomics Co. Ltd, Gyeonggi-do, Korea 1348896.55% (88.09% to 99.58%)100% (88.43% to 100.00%)Feb 22 - Mar 4, 2021
26GenePro SARS-CoV-2 Test (REF CV002)Gencurix, Guro-gu, Seoul, Korea96.55% (88.09% to 99.58%)100% (88.43% to 100.00%)Feb 22 - Mar 4, 2021
27Zybio SARS-CoV-2 Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) (REF: CoV2-32)Zybio Inc., China100% (94.04% to 100%)100% (88.43% to 100.00%)Mar 3 - Mar 9, 2021
28CWBio Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing)CWBio, China91.38% (81.02% to 97.14%)100% (87.23% to 100.00%)Mar 30 - Apr 1, 2021
29BGI Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 (updated evaluation)BGI Genomics Co. Ltd., Shenzhen, China96.49% (87.89% to 99.57%)100% (86.28% to 100.00%)April 20-27, 2021
30Primerdesign Genesig Easy kit for 2019-nCoV for use on genesig q16 instrumentPrimerdesign Ltd, School Lane, Chandler’s Ford, UK, SO53 4DG89.29% (95% CI, 78.12% to 95.97%)100% (95% CI, 87.23% to 100%)April 20-28, 2021
31QIAstat-Dx Respiratory SARS-CoV-2 Panel for use on the QIAstat-Dx Analyzer 1.0Qiagen Str. 1, 40724 Hilden, Germany86.00% (95% CI, 73.26% to 94.18%)100% (95% CI, 86.28% to 100.00%)April 14 - May 20, 2021
32BIOMERIEUX ARGENE SARS-COV-2 R GENEbioMerieux SA, 376 Chemin de l’Orme, 69280 Marcy-l’Etoile-France98.18% (95% CI, 90.28% to 99.95%)100% (95% CI, 86.77% to 100.00%)May 10 - 20, 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.