A new study has revealed the top-performing point-of-care COVID-19 tests that meet the recently published World Health Organization (WHO) “desirable” Target Product Profile (TPP) criteria.
Researchers at NSF International and Novateur Ventures screened more than 1,100 independently assessed point-of-care COVID-19 tests, identifying five direct antigen/RNA tests that detect acute COVID-19 infection and six indirect antibody tests for detection of prior infection.
The researchers hope the study, which appears in the journal Diagnostics, will help communities and healthcare systems make more informed decisions when choosing rapid, point-of-care COVID-19 tests.
Getting the best results
The researchers screened more than 300 COVID-19 diagnostic tests that have obtained US Food and Drug Administration (FDA) Emergency Use Authorization (EUA), and more than 850 tests that are listed on the Switzerland-based Foundation for Innovative New Diagnostics (FIND) database.
Robyn Meurant, Executive Director of Health Sciences at NSF International, said: “As communities around the world consider expanding existing COVID-19 testing strategies to include large-scale, rapid point-of-care tests, it’s essential for them to understand which tests work best in different situations.
“Our previous research found significant variability in performance and features of commercially available point-of-care tests, which makes it difficult to select and procure an appropriate test for a specific use case.”
According to the study, the following COVID-19 POCTs met the WHO TPP “desirable” criteria for clinical sensitivity/specificity, limit of detection, and time to results:
Direct (Antigen/RNA) POC Tests
- DetectaChem MobileDetect Bio BCC19 Test (RT-LAMP)
- Mammoth Biosciences SARS-CoV-2 Detectr Test (RT-LAMP/CRISPR)
- Quidel Sofia-2 Flu+SARS Antigen Test
- Seasun Biomaterials AQ-TOP Plus COVID-19 Rapid Test (RT-LAMP)
- Shenzhen Bioeasy Biotechnology Bioeasy Diagnostic Kit COVID-19 Antigen Test
Indirect (Antibody) POC Tests
- Guangzhou Wondfo Biotech Wondfo SARS-CoV-2 Ab Test 1
- Hangzhou Biotest Biotech RightSign COVID-19 IgG/IgM Rapid Test
- Hangzhou AllTest Biotech AllTest COVID-19 IgG/IgM Rapid Test 1
- NG Biotech NG IgG/IgM Rapid Test
- Sugentech SGTi-flex COVID-19 IgG
- VivaChek Biotech COVID-19 IgM/IgG Rapid Test
Study co-author Ali Ardakani, Founder & Managing Director at Novateur Ventures, said: “The COVID-19 pandemic will continue to pose a major public health threat until vaccination mediated herd immunity is achieved. Most projections predict vaccines will reach a large subset of the population in late 2021 or early 2022. Until then, there will continue to be a need for fast and accurate COVID-19 testing.”
Meurant added: “A few weeks have passed since we conducted our research in December 2020, so it is likely that additional tests have undergone independent assessment and can meet the WHO criteria now.
“The most important takeaway from this study is that purchasers of point-of-care COVID tests should do their research and make sure they are selecting a test that meets the WHO TPP criteria for their specific use case.”