EVALUATION OF RAPID Ab TEST KITS
Last updated: 03 February 2021

The Research Institute for Tropical Medicine (RITM), as the National Reference Laboratory, is mandated to perform the evaluation of commercially-manufactured in vitro diagnostic medical devices, in collaboration with the Philippine Food and Drug Administration (FDA).

In support of the national COVID-19 response, the Institute has undertaken evaluation of laboratory test kits (PCR, rapid antibody, rapid antigen kits), nucleic acid extraction kits, as well as virus transport media and swabs.

Read more about the guidelines on the evaluation of in vitro diagnostic medical devices and other related laboratory diagnostic supplies for COVID-19 here.

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 Rapid Antibody Test Kits to be used in COVID-19 testing, HTAC recommends a minimum sensitivity and specificity of 98% (CI: 96-100%) for specimens collected 20 days or more after the appearance of first symptoms. This standard metric is explained in depth in the Guidance Document on the Technical Requirements for SARS-COV-2 Rapid Antibody Test Kits as an adjunct test for COVID-19 published by HTAC in July 2020.

results
# Rapid Antibody Test Kits Manufacturer IgM Clinical Sensitivity (95% CI) IgM Clinical Specificity (95% CI) IgG Clinical Sensitivity (95% CI) IgG Clinical Specificity (95% CI) OVERALL Date Submitted Date Performed TAT for testing
Day 8-14 Day 15-21 Day ≥ 22 TOTAL Day 8-14 Day 15-21 Day ≥ 22 TOTAL SENSITIVITY SPECIFICITY
1 Rapid 2019-nCOV IgM/IgG Combo Test Card – (Xiamen Boson Biotech) Xiamen Boson Biotech 41.67% (15.17 to 72.33) 69.67% (29.33 to 92.51) 69.67% (34.89 to 90.08) 88.89% (51.75 to 99.72) 64.29% (48.03 to 78.45) April 26-30, 2020
2 SARS-COV-2 Antibody Test (Lateral Flow Method) – (Guangzhou Wondfo Biotech Co. Ltd) Guangzhou Wondfo Biotech Co. Ltd. 100% (86.28 to 100) 100% (86.28 to 100) 100% (86.28 to 100) 100% (95.20 to 100) 100% (95.20 to 100) 100% (86.28 to 100) 100% (86.28 to 100) 100% (86.28 to 100) 100% (95.20 to 100) 100% (95.20 to 100) 100% (95.20 to 100) 100% (95.20 to 100) November 9, 2020 November 10, 2020 1
3 WANTAI SARS- CoV Ab Rapid Test Kit – (Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.) Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. 100% (86.28 to 100) 100% (86.28 to 100) 100% (86.28 to 100) 100% (95.20 to 100) 100% (95.20 to 100) 100% (86.28 to 100) 100% (86.28 to 100) 100% (86.28 to 100) 100% (95.20 to 100) 100% (95.20 to 100) 100% (95.20 to 100) 100% (95.20 to 100) November 10, 2020 N/A(DONATION)
4 2019-nCoV Antibody Test (Colloidal Gold) – (Innovita (Tangshan) Biological Technology Co., Ltd.) Innovita (Tangshan) Biological Technology Co., Ltd. 0% 0% 4.0% (0.10 to 20.35) 1.33% (0.03 to 7.21) 100% (95.20 to 100) 56% (34.93 to 75.60) 52% (31.31 to 72.20) 72% (50.61 to 87.93) 60% (48.04 to 71.15) 100% (95.20 to 100) 30.67% (23.41 to 38.71) 100% (97.57 to 100) November 7, 2020< November 10, 2020 3
5 COVID-19 IgG/IgM Rapid Test Kit – (Hangzhou Zheda Dixun Biological Gene Engineering Co. Ltd.) Hangzhou Zheda Dixun Biological Gene Engineering Co. Ltd. 80% (59.30 to 93.17) 92% (73.97 to 99.02) 92% (73.97 to 99.02) 88% (78.44 to 94.36) 98.67% (92.79 to 99.97) 80% (59.30 to 93.17) 72% (50.61 to 87.93) 88% (68.78 to 97.45) 80% (69.17 to 88.35) 100% (95.20 to 100) 84% (77.14 to 89.47) 99.33% (96.34 to 99.98) November 10, 2020 N/A(DONATION)
6 VivaDiag™ COVID-19 IgM/IgG Rapid Test – (Vivachek Biotech Hangzhou Co. Ltd.) Vivachek Biotech Hangzhou Co. Ltd. 100% (86.28 to 100) 84% (63.92 to 95.46) 92% (73.97 to 99.02) 92% (83.40 to 97.01) 98.67% (92.79 to 99.97) 92% (73.97 to 99.02) 84% (63.92 to 95.46) 100% (86.28 to 100) 92% (83.40 to 97.01) 100% (95.20 to 100) 92% (86.44 to 95.80) 99.33% (96.34 to 99.98) November 11, 2020 November 17, 2020 6
7 Cellex qSARS-COV-@ IgG/IgM Casette Rapid Test – (Cellex Inc.) Cellex Inc. 88% (68.78 to 97.45) 80% (59.30 to 93.17) 76% (54.87 to 90.64) 81.33% (70.67 to 89.40) 98.67% (92.79 to 99.97) 100% (86.28 to 100) 96% (79.65 to 99.90) 96% (79.65 to 99.90) 97.33% (90.70 to 99.68) 100% (95.20 to 100) 89.33% (83.26 to 93.78) 99.33% (96.34 to 99.98) November 16, 2020 November 17, 2020 1
8 Abbott Panbio™ COVID-19 lgG/lgM Rapid Test Device – (Abbot Rapid Diagnostics Jena GmbH) Abbot Rapid Diagnostics Jena GmbH 76% (54.87 to 90.64) 92% (73.97 to 99.02) 72% (50.61 to 87.93) 80% (69.17 to 88.35) 98.67% (92.79 to 99.97) 96% (79.65 to 99.90) 76% (54.87 to 90.64) 96% (79.65 to 99.90) 89.33% (80.06 to 95.28) 100% (95.20 to 100) 84.67% (77.89 to 90.02) 99.33% (96.34 to 99.98) November 17-23, 2020 N/A(DONATION)
9 Platelia SARS-CoV-2 Total Ab Bio-Rad Laboratories 100% (86.28 to 100) 84% (63.92 to 95.46) 92% (73.97 to 99.02) 92% (83.40 to 97.01) 100% (95.20 to 100) 100% (86.28 to 100) 84% (63.92 to 95.46) 92% (73.97 to 99.02) 92% (83.40 to 97.01) 100% (95.20 to 100) 92% (83.40 to 97.01) 100% (95.20 to 100) November 19, 2020
10 Camtech COVID-19 IgM/IgG – (Camtech Biomedical Pte. Ltd) Camtech Biomedical Pte. Ltd. 88% (68.78 to 97.45) 72% (50.61 to 87.93) 88% (68.78 to 97.45) 82.67 (72.19 to 90.43) 98.67% (92.79 to 99.97) 84% (63.92 to 95.46) 72% (50.61 to 87.93) 92% (73.97 to 99.02) 82.89% (72.53 to 90.57) 100% (95.20 to 100) 82.67% (75.64 to 88.35 99.33% (96.34 to 99.98) December 02, 2020 December 02, 2020 0
11 HIGHTOP COVID-19 IgM/IgG Ab Rapid Test Kit Qingdao Hightop Biotech Co. Ltd. 48% (27.80 to 68.69) 48% (27.80 to 68.69) 52% (31.31 to 72.20) 49.33% (37.58 to 61.14) 100% (92.50 to 100) 92% (73.97 to 99.02) 80% (59.30 to 93.17) 100% (86.28 to 100) 90.67% (81.71 to 96.16) 48% (27.80 to 68.69) 70% (61.99 to 77.20) 100% (97.57 to 100) November 16, 2020 December 02, 2020 16
12 CLUNGENE COVID-19 IgG/IgM Rapid Test Cassette Hangzhou Clongene Biotech Co Ltd 96% (79.65 to 99.90) 88% (68.78 to 97.45) 84% (63.92 to 95.46) 89.33% (80.06 to 95.28) 100% (92.50 to 100) 92% (73.97 to 99.02) 92% (73.97 to 99.02) 100% (86.28 to 100) 94.67% (86.90 to 98.53) 100% (92.50 to 100) 92% (86.44 to 95.80) 99.33% (96.34 to 99.98) November 16, 2020 December 02, 2020 16
13 COVID-19) IgM/IgG Test Kit (Dry Fluorescence Immunoassay) Lansion Biotechnology Co., Ltd. 76% (54.87 to 90.64) 76% (54.87 to 90.64) 68% (46.50 to 85.05) 73.33% (61.86 to 82.89) 92% (83.40 to 97.01) 80% (59.30 to 93.17) 72% (50.61 to 87.93) 72% (50.61 to 87.93) 74.67% (63.3 to 84.01) 100% (95.20 to 100) 74% (66.21 to 80.81) 96% (91.50 to 98.52) December 1, 2020 December 03, 2020 2
14 Covid-19 IgG/IgM Rapid Test Zhuhai Livzon Diagnostic Inc. 88% (68.78 to 97.45) 80% (59.30 to 93.17) 84% (63.92 to 95.46) 84% (73.72 to 91.45) 100% (95.20 to 100) 80% (59.30 to 93.17) 64% (42.52 to 82.03) 88% (68.78 to 97.45) 77.33% (66.21 to 86.21) 100% (95.20 to 100) 80.67% (73.43 to 86.65) 100% (97.57 to 100) December 03, 2020 December 10, 2020 7
15 Anti-SARS-CoV-2 Rapid Test Autobio Diagnostic Co., Ltd. 96% (79.65 to 99.90) 92% (73.97 to 99.02) 88% (68.78 to 97.45) 92% (83.40 to 97.01) 97.33% (90.70 to 99.68) 92% (73.97 to 99.02) 100% (86.28 to 100) 100% (86.28 to 100) 97.33% (90.70 to 99.68) 94.67% (86.90 to 98.53) 94.67% (89.76 to 97.67) 96% (91.50 to 98.52) December 03, 2020 December 10, 2020 3

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.