EVALUATION OF RAPID Ab TEST KITS
Last updated: 17 May 2023
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 | 2019-nCoV Antibody Test (Colloidal Gold) | 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 |
| 3 | WANTAI SARS- CoV Ab Rapid Test Kit | 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 | SARS-COV-2 Antibody Test (Lateral Flow Method) | 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 |
| 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 | 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 |
| 10 | 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 |
| 11 | 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 |
| 12 | Camtech COVID-19 IgM/IgG | 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 |
| 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 |
| 39 | FREND COVID-19 total Ab | Nanoentek, Inc. | 88% (68.78 to 97.45) | 96% (79.65 to 99.90) | 100% (86.28 to 100.00) | 94.67% (86.90 to 98.53) | 98.67% (92.79 to 99.97) | 88% (68.78 to 97.45) | 96% (79.65 to 99.90) | 100% (86.28 to 100.00) | 94.67% (86.90 to 98.53) | 98.67% (92.79 to 99.97) | 94.67% (86.90 to 98.53) | 98.67% (92.79 to 99.97) | May 4, 2021 |
| 40 | ichroma™ COVID-19 Ab | Boditech Med Inc.’s Technical Services | 84% (63.92 to 95.46) | 92% (73.97 to 99.02) | 92% (73.97 to 99.02) | 89.33% (80.06 to 95.28) | 97.33% (90.70 to 99.68) | 96% (79.65 to 99.90) | 100% (86.28 to 100.00) | 100% (86.28 to 100.00) | 98.67% (92.79 to 99.97) | 94.67% (86.90 to 98.53) | 94.00% (88.92 to 97.22) | 96.00% (91.50 to 98.52) | June 10, 2021 |
| 41 | Rapid Immunochromatographic Test for Detection of IgG/IgM Antibodies to Coronavirus 2019-nCoV | Xiamen Biotime Biotechnology Co. | 96% (79.65 to 99.90) | 100% (86.28 to 100.00) | 100% (86.28 to 100.00) | 98.67% (92.79 to 99.97) | 100% (95.20 to 100.00) | 88% (68.78 to 97.45) | 96% (79.65 to 99.90) | 100% (86.28 to 100.00) | 94.67% (86.90 to 98.53) | 98.67% (92.79 to 99.97) | 96.67% (92.39 to 98.91) | 99.33% (96.34 to 99.98) | April 15, 2021 |
| 42 | GenSureTM COVID-19 IgG/IgM Rapid Test | Hebei Gensure Biotech Inc. | 96% (79.65 to 99.90) | 100% (86.28 to 100.00) | 100% (86.28 to 100.00) | 98.67% (92.79 to 99.97) | 88% (78.44 to 94.36) | 96% (79.65 to 99.90) | 96% (79.65 to 99.90) | 100% (86.28 to 100.00) | 97.33% (90.70 to 99.68) | 100% (95.20 to 100.00) | 98.00% (94.27 to 99.59) | 94.00% (88.92 to 97.22) | April 15, 2021 |
| 43 | Aria COVID-19 IgG/IgM Rapid Test | CTK Biotech, Inc. | 96% (79.65 to 99.90) | 100% (86.28 to 100.00) | 100% (86.28 to 100.00) | 98.67% (92.79 to 99.97) | 98.67% (92.79 to 99.97) | 68% (46.50 to 85.05) | 88% (68.78 to 97.45) | 96% (79.65 to 99.90) | 84.00% (73.72 to 91.45) | 100.00% (95.20 to 100.00) | 91.33% (85.64 to 95.30) | 99.33% (96.34 to 99.98) | October 15, 2021 |
| 44 | Nanjing Vazyme 2019-nCoV IgG/IgM Detection Kit | Nanjing Vazyme Medical Technology Co., Ltd | 36% (17.97 to 57.48) | 36% (17.97 to 57.48) | 44% (24.40 to 65.07) | 38.67% (27.64 to 50.62) | 100% (95.20 to 100.00) | 92% (73.97 to 99.02) | 88% (68.78 to 97.45) | 100% (86.28 to 100.00) | 93.33% (85.12 to 97.80) | 100.00% (95.20 to 100.00) | 66% (57.83 to 73.53) | 100% (97.57 to 100.00) | July 6, 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.