EVALUATION OF POLYMERASE CHAIN REACTION (PCR) KITS
Last updated: 30 September 2022

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.

NoKit NameManufacturerSARS-Cov-2 Gene Target/sSensitivity (95% CI)Specificity (95% CI)Date Performed
1A*STAR FORTITUDE KIT 2.0 COVID19 RT-PCR TESTAccelerate Technologies PTEORF1ab100% (88.40-100%)100% (88.40-100%)April 01-02
2Primerdesign Ltd COVID19 Genesig® Real-Time PCR AssayPrimerdesign LTDSARS-CoV-2
(did not mention specific gene targets)
96.67% (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, LTDORF1AB, N, E100% (88.4-100%)100% (88.40-100%)April 16-17
4GenAmplify™ Corona Virus Disease 2019 (COVID19) rRT-PCR Detection KitManila HealthTek Inc.RdRp, E78.95% (54.43-93.95)100% (84.56-100%)April 02-21
5DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection KitSolgent Co, LTDORF1a, N100% (88.43 to 100%)93.33% (77.93 to 99.18%)April25-26
6Allplex™ 2019-nCoV AssaySeegene Inc.RdRP, N, E100% (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-930)Da An Gene Co. Ltd of Sun Yat-sen UniversityORF1AB, N100% (88.43 to 100%)100% (88.43 to 100%)May 04-05
8abTES™ COVID-19 qPCR I Kit (v1.0)AIT Biotech PTE, LTDNS1, NS2100% (88.43 to 100%)100% (88.43 to 100%)May 07-08
9Genefinder COVID-19 Plus RealAmp KitOsang HealthcareRdRp, N, E100% (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/SORF1ab100% (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.E, RdRp88.37% (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, PRCORF1ab, E, N96.23% (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 BiosystemsORF1ab, S, N100% (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 BiotechORF1ab, N100% (92.45% to 100%)100% (88.43% to 100%)July 22-24
15ProTect™ COVID-19 RT-qPCR KitJN Medsys, SingaporeN1, N2, N3100% (88.43% to 100%)100% (88.43% to 100%)September 1-4
16Standard M nCoV Real-Time Detection KitSD BiosensorORF1ab, E100% (88.43% to 100%)100% (88.43% to 100%)September 7-11
17Sentinel STAT-NAT® COVID-19 MULTISentinel DiagnosticsORF1ab, RdRp73.68% (60.34% to 84.46%)100% (89.11% to 100%)September 14-21
18PowerChek 2019-nCoV Real-time PCR KitKogene Biotech Co.E, RdRp98.31% (90.91% to 99.96%)100% (88.43% to 100%)October 6-19
19FTD SARS-CoV-2 (FTD-114-96)Siemens, Healthineers CompanyN, ORF1ab100% (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 ChinaE, ORF1ab, N79.31%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 ChinaE, ORF1ab, N87.93% (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 KoreaN, ORF1ab48.28% (4.95% 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., LtdORF1ab, N100% (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, GermanyORF1ab/S, E84.75% (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 13488RdRp, E96.55% (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, KoreaORF1ab, E96.55% (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/CoV2-96)Zybio Inc., ChinaORF1ab, N100% (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, ChinaORF1ab, N91.38% (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, ChinaORF1ab96.49% (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 4DGORF1ab, E89.29% (78.12% to 95.97%)100% (87.23% to 100%)April 20-28, 2021
31BIOMERIEUX ARGENE SARS-COV-2 R GENEbioMerieux SA, 376 Chemin de l’Orme, 69280 Marcy-l’Etoile-FranceN, RdRp98.18%(90.28% to 99.95%)100% (86.77% to 100.00%)May 10 - 20, 2021
32STAT-NAT®COVID-19 MULTI REF 1N041Sentinel DiagnosticsORF1ab/RdRp100% (94.04% to 100.00%)100% (87.66% to 100.00%)May 21- June 3, 2021
33MirXes Fortitude kit 2.1 COVID-19 RT-PCR testMiRXes Pte LdORF1ab Region 1,
ORF1ab Region 2
100% (88.43% to 100%)100% (88.43% to 100%)October 1 - 9, 2020
34Zybio SARS-CoV-2 Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) Cat No. 4080102Zybio Inc., ChinaN, RdRp, E90.74% (79.70% to 96.92%)100.00 % (88.43% to 100%)July 28 - August 11, 2021
35OPTI SARS-CoV-2 RT-PCR TEST KIT (Catalog no. 99-57004)Optimedical System, Inc., 235 Hembree Park Drive, Roswell, Georgia USASARS-Cov-2 (N1, N2)100% (94.04% to 100.00%)100% (88.43% to 100.00%)Aug 18-20, 2021
36KimForest SARS-CoV-2 Detection Kit v1 (Catalog number: KF2019CoV01)KimForest Enterprise Co. Ltd.
New Taipei City, Taiwan
RdRp92.86% (82.71% to 98.02%)100%(88.43% to 100.00%)Aug 31- Sep 8 2021
37U-TOP™COVID-19 Detection Kit Plus (Cat. no. SS-9950)SEASUN Biomaterials Inc.ORF1ab/RdRp, N, E, S100% (94.04% to 100.00%)96.3% (81.03% to 99.91%)Sep 3-10, 2021
38Real-Time PCR Kit for Novel Coronavirus 2019-nCoV (ORF1ab, N) (Item number: R030-20)Shenzhen Uni-medica Technology Co. LtdORF1ab, N100% (94.04% to 100.00%)100%(88.43% to 100.00%)Sep 10-14, 2021
39Allplex™ SARS-CoV-2 Assay (Cat no. RV10248X)Seegene, Inc. Taewon Bldg., 91 Ogeum-ro, Songpa-gu, Seoul 05548, Republic of KoreaE, RdRp/S, N98.31% (90.91% to 99.96%)100% (88.43% to 100.00%)Sep 11-15, 2022
40Ezplex SARS-COV-2 FAST G Kit (Catalog No. GNT2011)SML Genetree Co. LTD, Seoul Republic of KoreaRdRp, N71.67% (58.56% to 82.55%)100% (88.43% to 100.00%)Aug 28 - Sep 17, 2021
41RADI COVID-19 Detection Kit (Ref No. RV008)KH Medical Co., Ltd, Gyeonggi-do, Republic of KoreaS, RdRp90% (79.49% to 96.24%)100% (88.06% to 100.00%)Sep 22 - 24, 2021
42PCL COVID19 Speedy RT-PCR (Ref No. MD02)PCL Inc., #701, 99, Digital-ro 9-gil, Geumcheon-gu, Seoul, 08510, Republic of KoreaN, E91.38% (81.02% to 97.14%)100% (88.43% to 100.00%)Sep 29- Oct 4, 2021
43VereRT™ ZeroPrep™ COVID-19 PCR Kit (Catalog No. VRTC-CE200)Veredus Laboratories Pte Ltd.N95.00% (86.08% to 98.96%)96.67% (82.78% to 99.92%)Oct 1 - 5, 2021
44DirectDetect™ SARS-CoV-2 Detection Kit (PCR-Fluorescence Probe) Catalog No.: 6018000902/06/08Coyote Bioscience Co. Ltd.ORF1ab, N98.25% (90.61% to 99.96%)100.00% (88.43% to 100.00%)Oct 6 - 7, 2021
45Hunan Runmei Coronavirus COVID-19 Nucleic Acid Detection Kit (Fluorescent RT-PCR Method)Hunan Runmei, Gene Technology Co., LTDORF1ab, N95.00% (86.08% to 98.96%)100.00% (88.43% to 100.00%)Oct 20-25, 2021
46COVID-19 Real-Time PCR Kit (REF: HBRT-COVID-19)Chaozhou Hybribio Biochemistry LtdORF1ab, N100% (94.04% to 100.00%)100.00% (83.89% to 100.00%)Oct 20-25, 2021
47SARS-CoV-2 ELITe MGB® Kit
Cat. No. RTS170ING
ELITechGroup S.p.A. Corso Svizzera 185, 10149 Torino ItalyORF8, RdRp100% (94.04% to 100.00%)100.00% (88.43% to 100.00%)Oct 26 - Nov 4, 2021
48Molaccu COVID-19 Detection Kit Catalog Number: 40804101 and 40804102Zybio Inc., ChinaE, N96.77% (88.47% to 99.59%
)
100.00% (88.43% to 100.00%)Oct 28 - Nov 4, 2021
49BioGerm Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence
Probing) Catalog number: ZC-HX-201-2-JCX
Shanghai BioGerm Medical Technology Co., Ltd.ORF1ab, N100% (94.04% to 100.00%)100.00% (88.43% to 100.00%)Nov 3-4, 2021
50GeneFinder™COVID-19 Plus RealAmp Kit
Catalog number: IMFR-45
OSANG Healthcare Co., LtdRdRp, E, N100% (94.04% to 100.00%)100.00% (88.43% to 100.00%)Nov. 5-10, 2021
51Freeze-dried Novel Coronavirus (COVID-19) Nucleic Acid Detection Kit (Fluorescence PCR
method), Cat. No. PR2019-D
BioTeke Corporation (Wuxi) Co., LtdORF1ab, N95.00% (86.08% to 98.96%)100.00% (88.43% to 100.00%)Nov. 6-11, 2021
522019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection KitNanjing Vazyme Medical Technology Co., Ltd.ORF1ab, N100% (94.04% to 100.00%)100.00% (88.43% to 100.00%)Nov. 10-15, 2021
531copy™ COVID-19 qPCR 4plex Kit (Cat. No. M24MD100T)1drop Inc.,N, E, RdRp100.00% (93.73% to 100.00%)100% (88.43% to 100.00%)Nov 16-22, 2021
54DaAnGene Detection Kit for 2019-nCoV (PCR Fluorescence) (Cat No. DA0992/ DA0990)DAAN Gene Co.,ORF1ab, N100% (94.04% to 100.00%)100.00% (88.43% to 100.00%)Nov 17-22, 2021
55CoviPath™ COVID-19 RT-PCR Kit (Cat. No. A50780)Invitrogen Bioservices Private Ltd.ORF1ab, N100% (93.40% to 100.00%)100.00% (88.43% to 100.00%)November 26-December 2, 2021
56Zeesan SARS-CoV-2 Test Kit (Cat. No. 801302)Zeesan Biotech Co., Ltd.ORF1ab, N100.00% (93.28% to 100.00%)100.00% (88.43% to 100.00%)December 6-9, 2021
57"SARAGENE™ Corona Virus (2019 NCV) Test kit
Catalog number: CVD011-00001"
COSARA DIAGNOSTIC PRIVATE LIMITEDRdRP93.33% (83.80% to 98.15%)100.00% (88.43% to 100.00%)December 11-13, 2021
58TaqPathTM COVID-19, FluA, FluB Combo Kit (Cat. No. A49868)ThermoFisher Scientific, Life Technologies CorporationS, N100% (94.04% to 100.00%)100.00% (88.43% to 100.00%)December 20-24, 2021
59SARS-CoV-2, Influenza A Virus and Influenza B Virus Nucleic Acid Detection (Fluorescence RT-PCR Method)Hunan Runmei Gene Technology Co., LtdUnknown80.00% (67.67% to 89.22%)100.00% (88.43% to 100.00%)January 4-10, 2022
60TaqPathTM COVID-19 CE-IVD RT-PCR KitThermoFisher Scientific, Life Technologies CorporationORF1ab, N, S100% (94.04% to 100.00%)100.00% (88.43% to 100.00%)January 5-13, 2022
61Bio-Rad Reliance SC2/FluA/FluB RT-PCR Kit (IVD)Bio-Rad Laboratories, Inc.
N 100% (94.04% to 100.00%)100.00% (88.43% to 100.00%)January 18-21, 2022
62Standard M nCoV Real-Time Detection Kit (Ref No. 11NCO010-ML)SD Biosensor, Inc.ORF1ab, E100% (93.94% to 100.00%)100.00% (88.43% to 100.00%)Feb 4 - 11, 2022
63Ezplex® SARS-CoV-2 FAST KitSML Genetree Co. LTD, Seoul Republic of KoreaRdRp, N100.00% (93.73% to 100.00%)100.00% (88.43% to 100.00%)January 14 - February 21, 2022
64"Taqpath COVID-19 Combo Kit
Catalog number: A47814"
ThermoFisher Scientific, Life Technologies Corporation, 6055 Sunol Blvd, PleasantonORF1ab, N, S100.00% (94.04% to 100.00%)100.00% (87.66% to 100.00%)March 25-29, 2022
65LightMix Modular SARS-CoV-2 E+N UBC (Catalog number: 40-0770-96)TIB MOLBIOL E, N100.00% (94.04% to 100.00%)100.00% (85.18% to 100.00%)March 31 - April 04, 2022
66Real-Time Fluorescent RT-PCR Kit for detecting SARS-CoV-2, Influenza A Virus and Influenza B VirusBGI PathoGenesis Pharmaceutical Technology Co., Ltd.ORF1ab, Influenza A, Influenza B100.00 % (94.04% to 100.00%)100.00% (88.43% to 100.00%)March 17 - April 25, 2022
67Logix Smart™ Coronavirus Disease (COVID-19) Kit (Cat. No. COVID-K-001)Co-Diagnostics, Inc.RdRP96.61% (88.29% to 99.59%)100.00% (88.43% to 100.00%)April 1 - 11, 2022
68Real-Q 2019-nCOV Detection Kit (Cat. no. BS7nCoV)BioSewoomRdrp, E100.00% (94.04% to 100.0%)100.00% (88.43% to 100.00%)April 05 - 11, 2022
69Genepath CoviQuick v2.0 RT-qPCR KitBome TrivitronRdrp, N, E100.00% (94.04% to 100.0%)100.00% (88.43% to 100.00%)May 19 - June 9, 2022
70GenAmplify PCR kit 2.0Manila HealthTek Inc.E, Rdrp93.33% (83.80% to 98.15%)100.0% (88.43% to 100.0%)May 26 - June 02, 2022
71TATA MD CHECK RT-PCR OMISURETATA Medical and Diagnostics Limited,Rdrp, S gene, SGMA100.00 % (94.04% to 100.00%)100.00% (88.43% to 100.00%)June 8 - 14, 2022
72Promotor® SARS-CoV-2 RT-PCR Test KitBIOSITE MEDICAL INSTRUMENTSORF1ab, N, E100.00 % (94.04% to 100.00%)100.00% (88.43% to 100.00%)May 26 - June 23, 2022
73ViroKeyTM SARS-CoV-2 RT-PCR TestTOTAL POWERORF1ab, N, 100.00 % (94.04% to 100.00%)100.00% (88.43% to 100.00%)June 28 - July 05, 2022
74BGI Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2BGI Genomics Co. Ltd.ORF1ab, N gene 100.00 % (94.04% to 100.00%)100.00% (88.43% to 100.00%)July 4-7, 2022
75abTES COVID-19 qPCR Kit version 4AITbiotech Pte Ltds NS1, NS2100.00 % (94.04% to 100.00%)100.00% (88.43% to 100.00%)July 6-14, 2022
76Veri-Q nCoV-QM COVID-19 Multiplex Detection KitMiCo BioMed Co., LtdORF3a, N gene92.73% (82.41% to 97.98%)100% (88.43% to 100%)April 27, July 18, 2022
77STAT-NAT SARS-CoV-2 KitSentinel CH S.p.AN Gene, RdRP Gene, and E Gene100% (94.04% to 100.00%)100% (88.43% to 100.00%)July 18-28, 2022
78Resolute 2.0Alliance Biomed Pte ltd.N gene, E gene100.00% (94.04% to 100.00%)100.00% (88.43% to 100.00%)Aug 12 - Sept 06, 2022
79Zybio SARS-CoV-2 Assay KitZybio Inc., ChinaN gene, RdRP gene, S gene100.00% (93.94% to 100.00%)100.00% (87.66% to 100.00%)Sept 02-16, 2022
80Molaccu Fast SARS-CoV-2 RT-qPCR Detection KitZybio Inc., ChinaORF1ab gene, N gene100.00% (94.04% to 100.00%)100.00% (88.43% to 100.00%)Sept 02-16, 2022

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.