EVALUATION OF RAPID Ab TEST KITS
Last updated: 29 April 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.

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

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

STANDARDS

For Antibody Tests to be used in COVID-19 testing, the World Health Organization recommends a minimum sensitivity and specificity of > 98%. 

For Rapid Antibody Test Kits to be procured by the DOH,  HTAC recommends a minimum sensitivity and specificity of 98% 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. 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.

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 Performed
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 10, 2020
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
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 10, 2020
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
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 17, 2020
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 17, 2020
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
9 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
10 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) December 02, 2020
11 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) December 02, 2020
12 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 03, 2020
13 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 10, 2020
14 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 10, 2020
15 SARS-COV-2 IgGM/IgG Antibody Assay Kit (Colloidal Gold Method) Zybio, Inc. 92% (73.97 to 99.02) 84% (63.92 to 95.46) 80% (59.30 to 93.17) 85.33% (75.27 to 92.44) 100% (95.20 to 100) 76% (54.87 to 90.64) 68% (46.50 to 85.05) 84% (63.92 to 95.46) 76%( 64.75 to 85.11) 100% (95.20 to 100) 80.67% (73.43 to 86.65) 100% (97.57 to 100) January 26, 2021
16 SARS-CoV-2 Antibody Test (COLLOIDAL GOLD IMMUNOCHROMATOGRAPHY) Beijing Lepu Medical Technology Co., Ltd. 100% (86.28 to 100) 100% (86.28 to 100) 100% (86.28 to 100) 100% (95.20 to 100) 81.33% (70.67 to 89.40) 84% (63.92 to 95.46) 84% (63.92 to 95.46) 84% (63.92 to 95.46) 84% (63.92 to 95.46) 100% (95.20 to 100) 92% (86.44 to 95.80) 90.67% (84.84 to 94.80) January 27, 2021
17 COVID-19 IgG/IgM Rapid Test Cassette Hangzhou Biotest Biotech Co., Ltd. 100% (86.28 to 100) 100% (86.28 to 100) 100% (86.28 to 100) 100% (95.20 to 100) 98.67% (92.79 to 99.97) 84% (63.92 to 95.46) 80% (59.30 to 93.17) 92% (73.97 to 99.02) 85.33% (75.27 to 92.44) 98.67% (92.79 to 99.97) 92.67% (87.26 to 96.28) 98.67% (95.27 to 99.84) January 27, 2021
18 2019-nCOV/COVID-19 IgG/IgM Rapid Test Device Hangzhou Realy Tech Co., Ltd. 72% (50.61 to 87.93) 56% (34.93 to 75.60) 60% (38.67 to 78.87) 62.67% (50.73 to 73.57) 100% (95.20 to 100) 96% (79.65 to 99.99) 80% (59.30 to 93.17) 96% (79.65 to 99.90) 90.67% (81.71 to 96.16) 100% (95.20 to 100) 76.67% (69.07 to 83.18) 100% (97.57 to 100) January 27, 2021
19 2019 n-CoV IgG/IgM RAPID TEST CASSETTE Hangzhou Alltest Biotech Co., Ltd. 64% (42.52 to 82.03) 44% (24.40 to 65.07) 48% (27.80 to 68.69) 52% (40.15 to 63.69) 98.67% (92.79 to 99.97) 96% (79.65 to 99.90) 92% (73.97 to 99.02) 100% (86.28 to 100) 96% (88.75 to 99.17) 97.33% (90.70 to 99.68) 74% (66.21 to 80.81) 98% (94.27 to 99.59) February 10, 2021
20 NADAL COVID-19 IgG/IgM Test Nal Von Minden Gmbh 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) 88% (68.78 to 97.45) 84% (63.92 to 95.46) 92% (73.97 to 99.02) 88% (78.44 to 94.36) 100% (95.20 to 100) 92.67% (87.26 to 96.28) 100% (97.57 to 100) February 10, 2021
21 SARS-CoV2(COVID-19) IgG/IgM Antibody Test (Colloidal Gold) Hangzhou Testsea Biotechnology Co., Ltd. 100% (86.28 to 100) 92% (73.97 to 99.02) 92% (73.97 to 99.02) 94.67% (86.90 to 98.53) 85.33% (75.27 to 92.44) 100% (86.28 to 100) 100% (86.28 to 100) 100% (86.28 to 100) 100% (95.20 to 100) 26.67% (17.11 to 38.14) 97.33% (93.31 to 99.27) 56% (47.67 to 64.09) February 10, 2021
22 COVID-19 IgG/IgM RAPID TEST CASSETTE Healgen Scientific Limited 100% (86.28 to 100) 100% (86.28 to 100) 100% (86.28 to 100) 100% (95.20 to 100) 96% (88.75 to 99.17) 100% (86.28 to 100) 100% (86.28 to 100) 100% (86.28 to 100) 100% (95.20 to 100) 97.33% (90.70 to 99.68) 100% (97.57 to 100) 96.67% (92.39 to 98.91) February 10, 2021
23 COVID-19 IgM Antibody Rapid Test Kit Hecin Scientific, Inc. 84% (63.92 to 95.46) 68% (46.50 to 85.05) 68% (46.50 to 85.05) 73.33% (61.86 to 82.89) 100% (95.20 to 100) 73.33% (61.86 to 82.89) 100% (95.20 to 100) February 10, 2021
24 SARS-CoV-2 IgG/IgM Rapid Test Zhuhai Encode Medical Engineering Co., Ltd. 84% (63.92 to 95.46) 72% (50.61 to 87.93) 88% (68.78 to 97.45) 81.33% (70.67 to 89.40) 100% (95.20 to 100) 92% (73.97 to 99.02) 76% (54.87 to 90.64) 96% (79.65 to 99.90) 88% (78.44 to 94.36) 97.33% (90.70 to 99.68) 84.67% (77.89 to 90.02) 98.67% (95.27 to 99.84) February 10, 2021
25 2019-nCoV IgG/IgM Rapid Test Dynamiker Biotechnology (Tianjin) Co., Ltd. 88% (68.78 to 97.45) 88% (68.78 to 97.45) 100% (86.28 to 100) 92% (83.40 to 97) 98.67% (92.79 to 99.97) 88% (68.78 to 97.45) 88% (68.78 to 97.45) 100% (86.28 to 100) 92% (83.40 to 97) 98.67% (92.79 to 99.97) 92% (86.44 to 95.80) 98.67% (95.27 to 99.64) March 2, 2021
26 GenBody COVID-19 IgG/IgM RAPID DIAGNOSTIC TEST Genbody Inc. 16% (4.54 to 36.08) 20% (6.83 to 40.70) 20% (6.83 to 40.70) 18.67% (10.60 to 29.33) 100% (95.20 to 100) 52% (31.31 to 72.20) 56% (34.93 to 75.60) 44% (24.40 to 65.07) 50.67% (38.86 to 62.42) 100% (95.20 to 100) 34.67% (27.09 to 42.86) 100% (97.57 to 100) March 2, 2021
27 Novel Coronavirus (2019nCoV) IgG/IgM Test Kit (Colloidal Gold) Genrui Biotech Inc. 72% (50.61 to 87.93) 64% (42.52 to 82.03) 72% (50.61 to 87.93) 69.33% (57.62 to 79.47) 98.67% (92.79 to 99.97) 68% (45.60 to 85.05) 92% (73.97 to 99.02) 96% (79.65 to 99.90) 85.33% (75.27 to 92.44) 100% (95.20 to 100) 77.33% (69.79 to 83.76) 99.33% (96.34 to 99.98) March 2, 2021
28 COVID-19 IgG/IgM RAPID TEST CASSETTE Zhejiang Orient Gene Biotech Co., Ltd. 92% (73.97 to 99.02) 100% (86.28 to 100) 96% (79.65 to 99.90) 96% (88.75 to 99.17) 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) 98.67% (92.79 to 99.97) 98% (94.27 to 99.59) 99.33% (96.34 to 99.98) March 2, 2021
29 QuickProfile COVID-19 IgG/IgM Combo Test Card Lumiquick Diagnostics Inc. 92% (73.97 to 99.02) 96% (79.65 to 99.90) 92% (73.97 to 99.02) 93.33% (85.12 to 97.80) 100% (95.20 to 100) 88% (68.78 to 97.45) 100% (86.28 to 100) 100% (86.28 to 100) 96% (88.75 to 99.17) 98.67% (95.79 to 99.97) 94.67% (89.76 to 97.67) 99.33% (96.34 to 99.98) March 3, 2021
30 Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit Biohit Healthcare (Hefei) Co., Ltd. 96% (79.65 to 99.90) 100% (86.28 to 100) 100% (86.28 to 100) 98.67% (92.79 to 99.97) 98.67% (92.79 to 99.97) 96% (79.65 to 99.90) 100% (86.28 to 100) 100% (86.28 to 100) 98.67% (92.79 to 99.97) 100% (95.20 to 100) 98.67% (95.27 to 99.84) 99.33% (96.34 to 99.98) March 10, 2021
31 SARS-CoV-2 IgG/IgM Kit Goldsite Diagnostics Inc. 64% (42.52 to 82.03) 52% (31.31 to 72.20) 64% (42.52 to 82.03) 60% (48.04 to 71.15) 100% (95.20 to 100) 96% (79.65 to 99.90) 100% (86.28 to 100) 100% (86.28 to 100) 98.67% (92.79 to 99.97) 97.33% (90.70 to 99.68) 79.33% (71.97 to 85.51) 98.67% (95.27 to 99.84) March 10, 2021
32 SGTi-flex COVID-19 IgM/IgG Sugentech Inc. 96% (79.65 to 99.90) 92% (73.97 to 99.02) 100% (86.28 to 100) 96% (87.75 to 99.17) 100% (95.20 to 100) 84% (63.92 to 95.46) 92% (73.97 to 99.02) 96% (79.65 to 99.90) 90.67% (81.71 to 96.16) 98.67% (92.79 to 99.97) 93.33% (88.08 to 96.76) 99.33% (96.34 to 99.98) March 10, 2021
33 COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test Kit Wuhan Easydiagnosis Biomedicine Co., Ltd. 96% (79.65 to 99.90) 100% (86.28 to 100) 96% (79.65 to 99.90) 97.33% (90.70 to 99.68) 100% (95.20 to 100) 68% (46.50 to 85.05) 88% (68.78 to 97.45) 88% (68.78 to 97.45) 81.33% (70.67 to 89.40) 100% (95.20 to 100) 89.33% (83.26 to 93.78) 100% (97.57 to 100) March 10, 2021
34 Anti-SARS-CoV-2 Rapid Test B-Bio, Co., Ltd. 84% (63.92 to 95.46) 76% (54.87 to 90.64) 84% (63.92 to 95.46) 81.33% (70.67 to 89.40) 100% (95.20 to 100) 56% (34.93 to 75.60) 72% (50.61 to 87.93) 64% (42.52 to 82.03) 64% (52.09 to 74.77) 100% (95.20 to 100) 72.67% (64.80 to 79.62) 100% (97.57 to 100) March 10, 2021
35 Humasis COVID-19 IgG/IgM Antibody Test Humasis Co., Ltd. 88% (68.78 to 97.45) 88% (68.78 to 97.45) 100% (86.28 to 100) 92% (83.40 to 97.01) 98.67% (92.79 to 99.97) 88% (68.78 to 97.45) 92% (73.97 to 99.02) 100% (86.28 to 100) 93.33% (85.12 to 97.80) 98.67% (92.79 to 99.97) 92.67% (87.26 to 96.28) 98.67% (95.27 to 99.84) March 10, 2021
36 COVID-19 IgG/IgM Rapid Test Kit Nantong Egens Biotechnology Co Ltd 92% (73.97 to 99.02) 100% (86.28 to 100.00) 100% (86.28 to 100.00) 97.33% (90.70 to 99.68) 100% (95.20 to 100.00) 100% (86.28 to 100.00) 100% (86.28 to 100.00) 100% (86.28 to 100.00) 100% (95.20 to 100.00) 97.33% (90.70 to 99.68) 98.67% (95.27 to 99.84) 98.67% (95.27 to 99.84) March 17, 2021
37 SARS-CoV-2 Rapid Antibody Test SD Biosensor Inc. (Roche) 88% (68.78 to 97.45) 96% (79.65 to 99.90) 84% (63.92 to 95.46) 89.33% (80.06 to 95.28) 100% (95.20 to 100.00) 92% (73.97 to 99.02) 96% (79.65 to 99.90) 96% (79.65 to 99.90) 94.67% (86.90 to 98.53) 100% (95.20 to 100.00) 92% (86.44 to 95.80) 100% (97.57 to 100.00) March 18, 2021
38 (2019-nCoV) New coronavirus Antibody Test (Colloidal Gold) Nantong Diagnos Biotechnology Co., Ltd. 92% (73.97 to 99.02) 92% (73.97 to 99.02) 96% (79.65 to 99.90) 93.33% (85.12 to 97.80) 97.33% (90.70 to 99.68) 76% (54.87 to 90.64) 92% (73.97 to 99.02) 100% (86.28 to 100.00) 89.33% (80.06 to 95.28) 97.33% (90.70 to 99.68) 91.33% (85.64 to 95.30) 97.33% (93.31 to 99.27) March 24, 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.