EVALUATION OF POLYMERASE CHAIN REACTION (PCR) KITS
Last updated: September 13, 2023
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.
| No | Kit Name | Manufacturer | SARS-Cov-2 Gene Target/s | Sensitivity (95% CI) | Specificity (95% CI) | Date Performed |
|---|---|---|---|---|---|---|
| 1 | A*STAR FORTITUDE KIT 2.0 COVID19 RT-PCR TEST | Accelerate Technologies PTE | ORF1ab | 100% (88.40-100%) | 100% (88.40-100%) | April 01-02 |
| 2 | Primerdesign Ltd COVID19 Genesig® Real-Time PCR Assay | Primerdesign LTD | SARS-CoV-2 (did not mention specific gene targets) | 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 | ORF1AB, N, E | 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. | RdRp, E | 78.95% (54.43-93.95) | 100% (84.56-100%) | April 02-21 |
| 5 | DiaPlexQÂ Novel Coronavirus (2019-nCoV) Detection Kit | Solgent Co, LTD | ORF1a, N | 100% (88.43 to 100%) | 93.33% (77.93 to 99.18%) | April25-26 |
| 6 | Allplex 2019-nCoV Assay | Seegene Inc. | RdRP, N, E | 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-930) | Da An Gene Co. Ltd of Sun Yat-sen University | ORF1AB, N | 100% (88.43 to 100%) | 100% (88.43 to 100%) | May 04-05 |
| 8 | abTESÂ COVID-19 qPCR I Kit (v1.0) | AIT Biotech PTE, LTD | NS1, NS2 | 100% (88.43 to 100%) | 100% (88.43 to 100%) | May 07-08 |
| 9 | Genefinder COVID-19 Plus RealAmp Kit | Osang Healthcare | RdRp, N, E | 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 | ORF1ab | 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. | E, RdRp | 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 | ORF1ab, E, N | 96.23% (87.02 to 99.54%) | 100% (88.43% to 100%) | June 27 Â 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 | ORF1ab, S, N | 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 | ORF1ab, N | 100% (92.45% to 100%) | 100% (88.43% to 100%) | July 22-24 |
| 15 | ProTect COVID-19 RT-qPCR Kit | JN Medsys, Singapore | N1, N2, N3 | 100% (88.43% to 100%) | 100% (88.43% to 100%) | September 1-4 |
| 16 | Standard M nCoV Real-Time Detection Kit | SD Biosensor | ORF1ab, E | 100% (88.43% to 100%) | 100% (88.43% to 100%) | September 7-11 |
| 17 | Sentinel STAT-NAT® COVID-19 MULTI | Sentinel Diagnostics | ORF1ab, RdRp | 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. | E, RdRp | 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 | N, ORF1ab | 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 | E, ORF1ab, N | 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 | E, ORF1ab, N | 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 | N, ORF1ab | 48.28% (4.95% 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 | ORF1ab, N | 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 | ORF1ab/S, E | 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 | RdRp, E | 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 | ORF1ab, E | 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/CoV2-96) | Zybio Inc., China | ORF1ab, N | 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 | ORF1ab, N | 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 | ORF1ab | 96.49% (87.89% to 99.57%) | 100% (86.28% to 100.00%) | April 20-27, 2021 |
| 30 | Primerdesign Genesig Easy kit for 2019-nCoV for use on genesig q16 instrument | Primerdesign Ltd, School Lane, ChandlerÂs Ford, UK, SO53 4DG | ORF1ab, E | 89.29% (78.12% to 95.97%) | 100% (87.23% to 100%) | April 20-28, 2021 |
| 31 | BIOMERIEUX ARGENE SARS-COV-2 R GENE | bioMerieux SA, 376 Chemin de lÂOrme, 69280 Marcy-lÂEtoile-France | N, RdRp | 98.18%(90.28% to 99.95%) | 100% (86.77% to 100.00%) | May 10 - 20, 2021 |
| 32 | STAT-NAT®COVID-19 MULTI REF 1N041 | Sentinel Diagnostics | ORF1ab/RdRp | 100% (94.04% to 100.00%) | 100% (87.66% to 100.00%) | May 21- June 3, 2021 |
| 33 | MirXes Fortitude kit 2.1 COVID-19 RT-PCR test | MiRXes Pte Ld | ORF1ab Region 1, ORF1ab Region 2 | 100% (88.43% to 100%) | 100% (88.43% to 100%) | October 1 - 9, 2020 |
| 34 | Zybio SARS-CoV-2 Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) Cat No. 4080102 | Zybio Inc., China | N, RdRp, E | 90.74% (79.70% to 96.92%) | 100.00 % (88.43% to 100%) | July 28 - August 11, 2021 |
| 35 | OPTI SARS-CoV-2 RT-PCR TEST KIT (Catalog no. 99-57004) | Optimedical System, Inc., 235 Hembree Park Drive, Roswell, Georgia USA | SARS-Cov-2 (N1, N2) | 100% (94.04% to 100.00%) | 100% (88.43% to 100.00%) | Aug 18-20, 2021 |
| 36 | KimForest SARS-CoV-2 Detection Kit v1 (Catalog number: KF2019CoV01) | KimForest Enterprise Co. Ltd. New Taipei City, Taiwan | RdRp | 92.86% (82.71% to 98.02%) | 100%(88.43% to 100.00%) | Aug 31- Sep 8 2021 |
| 37 | U-TOPÂCOVID-19 Detection Kit Plus (Cat. no. SS-9950) | SEASUN Biomaterials Inc. | ORF1ab/RdRp, N, E, S | 100% (94.04% to 100.00%) | 96.3% (81.03% to 99.91%) | Sep 3-10, 2021 |
| 38 | Real-Time PCR Kit for Novel Coronavirus 2019-nCoV (ORF1ab, N) (Item number: R030-20) | Shenzhen Uni-medica Technology Co. Ltd | ORF1ab, N | 100% (94.04% to 100.00%) | 100%(88.43% to 100.00%) | Sep 10-14, 2021 |
| 39 | Allplex SARS-CoV-2 Assay (Cat no. RV10248X) | Seegene, Inc. Taewon Bldg., 91 Ogeum-ro, Songpa-gu, Seoul 05548, Republic of Korea | E, RdRp/S, N | 98.31% (90.91% to 99.96%) | 100% (88.43% to 100.00%) | Sep 11-15, 2022 |
| 40 | Ezplex SARS-COV-2 FAST G Kit (Catalog No. GNT2011) | SML Genetree Co. LTD, Seoul Republic of Korea | RdRp, N | 71.67% (58.56% to 82.55%) | 100% (88.43% to 100.00%) | Aug 28 - Sep 17, 2021 |
| 41 | RADI COVID-19 Detection Kit (Ref No. RV008) | KH Medical Co., Ltd, Gyeonggi-do, Republic of Korea | S, RdRp | 90% (79.49% to 96.24%) | 100% (88.06% to 100.00%) | Sep 22 - 24, 2021 |
| 42 | PCL COVID19 Speedy RT-PCR (Ref No. MD02) | PCL Inc., #701, 99, Digital-ro 9-gil, Geumcheon-gu, Seoul, 08510, Republic of Korea | N, E | 91.38% (81.02% to 97.14%) | 100% (88.43% to 100.00%) | Sep 29- Oct 4, 2021 |
| 43 | VereRT ZeroPrep COVID-19 PCR Kit (Catalog No. VRTC-CE200) | Veredus Laboratories Pte Ltd. | N | 95.00% (86.08% to 98.96%) | 96.67% (82.78% to 99.92%) | Oct 1 - 5, 2021 |
| 44 | DirectDetect SARS-CoV-2 Detection Kit (PCR-Fluorescence Probe) Catalog No.: 6018000902/06/08 | Coyote Bioscience Co. Ltd. | ORF1ab, N | 98.25% (90.61% to 99.96%) | 100.00% (88.43% to 100.00%) | Oct 6 - 7, 2021 |
| 45 | Hunan Runmei Coronavirus COVID-19 Nucleic Acid Detection Kit (Fluorescent RT-PCR Method) | Hunan Runmei, Gene Technology Co., LTD | ORF1ab, N | 95.00% (86.08% to 98.96%) | 100.00% (88.43% to 100.00%) | Oct 20-25, 2021 |
| 46 | COVID-19 Real-Time PCR Kit (REF: HBRT-COVID-19) | Chaozhou Hybribio Biochemistry Ltd | ORF1ab, N | 100% (94.04% to 100.00%) | 100.00% (83.89% to 100.00%) | Oct 20-25, 2021 |
| 47 | SARS-CoV-2 ELITe MGB® Kit Cat. No. RTS170ING | ELITechGroup S.p.A. Corso Svizzera 185, 10149 Torino Italy | ORF8, RdRp | 100% (94.04% to 100.00%) | 100.00% (88.43% to 100.00%) | Oct 26 - Nov 4, 2021 |
| 48 | Molaccu COVID-19 Detection Kit Catalog Number: 40804101 and 40804102 | Zybio Inc., China | E, N | 96.77% (88.47% to 99.59% ) | 100.00% (88.43% to 100.00%) | Oct 28 - Nov 4, 2021 |
| 49 | BioGerm 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, N | 100% (94.04% to 100.00%) | 100.00% (88.43% to 100.00%) | Nov 3-4, 2021 |
| 50 | GeneFinderÂCOVID-19 Plus RealAmp Kit Catalog number: IMFR-45 | OSANG Healthcare Co., Ltd | RdRp, E, N | 100% (94.04% to 100.00%) | 100.00% (88.43% to 100.00%) | Nov. 5-10, 2021 |
| 51 | Freeze-dried Novel Coronavirus (COVID-19) Nucleic Acid Detection Kit (Fluorescence PCR method), Cat. No. PR2019-D | BioTeke Corporation (Wuxi) Co., Ltd | ORF1ab, N | 95.00% (86.08% to 98.96%) | 100.00% (88.43% to 100.00%) | Nov. 6-11, 2021 |
| 52 | 2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit | Nanjing Vazyme Medical Technology Co., Ltd. | ORF1ab, N | 100% (94.04% to 100.00%) | 100.00% (88.43% to 100.00%) | Nov. 10-15, 2021 |
| 53 | 1copy COVID-19 qPCR 4plex Kit (Cat. No. M24MD100T) | 1drop Inc., | N, E, RdRp | 100.00% (93.73% to 100.00%) | 100% (88.43% to 100.00%) | Nov 16-22, 2021 |
| 54 | DaAnGene Detection Kit for 2019-nCoV (PCR Fluorescence) (Cat No. DA0992/ DA0990) | DAAN Gene Co., | ORF1ab, N | 100% (94.04% to 100.00%) | 100.00% (88.43% to 100.00%) | Nov 17-22, 2021 |
| 55 | CoviPath COVID-19 RT-PCR Kit (Cat. No. A50780) | Invitrogen Bioservices Private Ltd. | ORF1ab, N | 100% (93.40% to 100.00%) | 100.00% (88.43% to 100.00%) | November 26-December 2, 2021 |
| 56 | Zeesan SARS-CoV-2 Test Kit (Cat. No. 801302) | Zeesan Biotech Co., Ltd. | ORF1ab, N | 100.00% (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 LIMITED | RdRP | 93.33% (83.80% to 98.15%) | 100.00% (88.43% to 100.00%) | December 11-13, 2021 |
| 58 | TaqPathTM COVID-19, FluA, FluB Combo Kit (Cat. No. A49868) | ThermoFisher Scientific, Life Technologies Corporation | S, N | 100% (94.04% to 100.00%) | 100.00% (88.43% to 100.00%) | December 20-24, 2021 |
| 59 | SARS-CoV-2, Influenza A Virus and Influenza B Virus Nucleic Acid Detection (Fluorescence RT-PCR Method) | Hunan Runmei Gene Technology Co., Ltd | Unknown | 80.00% (67.67% to 89.22%) | 100.00% (88.43% to 100.00%) | January 4-10, 2022 |
| 60 | TaqPathTM COVID-19 CE-IVD RT-PCR Kit | ThermoFisher Scientific, Life Technologies Corporation | ORF1ab, N, S | 100% (94.04% to 100.00%) | 100.00% (88.43% to 100.00%) | January 5-13, 2022 |
| 61 | Bio-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 |
| 62 | Standard M nCoV Real-Time Detection Kit (Ref No. 11NCO010-ML) | SD Biosensor, Inc. | ORF1ab, E | 100% (93.94% to 100.00%) | 100.00% (88.43% to 100.00%) | Feb 4 - 11, 2022 |
| 63 | Ezplex® SARS-CoV-2 FAST Kit | SML Genetree Co. LTD, Seoul Republic of Korea | RdRp, N | 100.00% (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, Pleasanton | ORF1ab, N, S | 100.00% (94.04% to 100.00%) | 100.00% (87.66% to 100.00%) | March 25-29, 2022 |
| 65 | LightMix Modular SARS-CoV-2 E+N UBC (Catalog number: 40-0770-96) | TIB MOLBIOL | E, N | 100.00% (94.04% to 100.00%) | 100.00% (85.18% to 100.00%) | March 31 - April 04, 2022 |
| 66 | Real-Time Fluorescent RT-PCR Kit for detecting SARS-CoV-2, Influenza A Virus and Influenza B Virus | BGI PathoGenesis Pharmaceutical Technology Co., Ltd. | ORF1ab, Influenza A, Influenza B | 100.00 % (94.04% to 100.00%) | 100.00% (88.43% to 100.00%) | March 17 - April 25, 2022 |
| 67 | Logix Smart™ Coronavirus Disease (COVID-19) Kit (Cat. No. COVID-K-001) | Co-Diagnostics, Inc. | RdRP | 96.61% (88.29% to 99.59%) | 100.00% (88.43% to 100.00%) | April 1 - 11, 2022 |
| 68 | Real-Q 2019-nCOV Detection Kit (Cat. no. BS7nCoV) | BioSewoom | Rdrp, E | 100.00% (94.04% to 100.0%) | 100.00% (88.43% to 100.00%) | April 05 - 11, 2022 |
| 69 | Genepath CoviQuick v2.0 RT-qPCR Kit | Bome Trivitron | Rdrp, N, E | 100.00% (94.04% to 100.0%) | 100.00% (88.43% to 100.00%) | May 19 - June 9, 2022 |
| 70 | GenAmplify PCR kit 2.0 | Manila HealthTek Inc. | E, Rdrp | 93.33% (83.80% to 98.15%) | 100.0% (88.43% to 100.0%) | May 26 - June 02, 2022 |
| 71 | TATA MD CHECK RT-PCR OMISURE | TATA Medical and Diagnostics Limited, | Rdrp, S gene, SGMA | 100.00 % (94.04% to 100.00%) | 100.00% (88.43% to 100.00%) | June 8 - 14, 2022 |
| 72 | Promotor® SARS-CoV-2 RT-PCR Test Kit | BIOSITE MEDICAL INSTRUMENTS | ORF1ab, N, E | 100.00 % (94.04% to 100.00%) | 100.00% (88.43% to 100.00%) | May 26 - June 23, 2022 |
| 73 | ViroKeyTM SARS-CoV-2 RT-PCR Test | TOTAL POWER | ORF1ab, N, | 100.00 % (94.04% to 100.00%) | 100.00% (88.43% to 100.00%) | June 28 - July 05, 2022 |
| 74 | BGI Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2 | BGI Genomics Co. Ltd. | ORF1ab, N gene | 100.00 % (94.04% to 100.00%) | 100.00% (88.43% to 100.00%) | July 4-7, 2022 |
| 75 | abTES COVID-19 qPCR Kit version 4 | AITbiotech Pte Ltd | s NS1, NS2 | 100.00 % (94.04% to 100.00%) | 100.00% (88.43% to 100.00%) | July 6-14, 2022 |
| 76 | Veri-Q nCoV-QM COVID-19 Multiplex Detection Kit | MiCo BioMed Co., Ltd | ORF3a, N gene | 92.73% (82.41% to 97.98%) | 100% (88.43% to 100%) | April 27, July 18, 2022 |
| 77 | STAT-NAT SARS-CoV-2 Kit | Sentinel CH S.p.A | N Gene, RdRP Gene, and E Gene | 100% (94.04% to 100.00%) | 100% (88.43% to 100.00%) | July 18-28, 2022 |
| 78 | Resolute 2.0 | Alliance Biomed Pte ltd. | N gene, E gene | 100.00% (94.04% to 100.00%) | 100.00% (88.43% to 100.00%) | Aug 12 - Sept 06, 2022 |
| 79 | Zybio SARS-CoV-2 Assay Kit | Zybio Inc., China | N gene, RdRP gene, S gene | 100.00% (93.94% to 100.00%) | 100.00% (87.66% to 100.00%) | Sept 02-16, 2022 |
| 80 | Molaccu Fast SARS-CoV-2 RT-qPCR Detection Kit | Zybio Inc., China | ORF1ab gene, N gene | 100.00% (94.04% to 100.00%) | 100.00% (88.43% to 100.00%) | Sept 02-16, 2022 |
| 81 | Sansure Biotech SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) | Sansure Biotech | ORF1ab, N gene | 100.00% (94.04% to 100.00%) | 100.00% (88.43% to 100.00%) | Oct 3 - 18, 2022 |
| 82 | ANDiS FAST SARS-CoV-2 RT-qPCR Detection Kit | 3D Biomedicine Science & Technology Co., Limited | ORF1ab gene, N gene, E gene | 100.00% (94.04% to 100.00%) | 100.00% (88.43% to 100.00%) | Oct 24-26, 2022 |
| 83 | ANDis SARS-CoV-2 and Influenza A/B RT-qPCR Detection Kit | 3D Biomedicine Science & Technology Co., Limited | ORF1ab, E gene, N gene | 100.00% (94.04% to 100.00%) | 100.00% (88.43% to 100.00%) | Nov 9-16, 2022 |
| 84 | MiRXES Fortitude Kit 4.0 | MiRXES Pte Ltd | ORF1ab, N gene | 100.00% (94.04% to 100.00%) | 100.00% (88.43% to 100.00%) | Jan 12-27, 2023 |
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.