After screening more than 1,100 independently assessed, point-of-care COVID-19 tests, researchers at NSF International and Novateur Ventures have identified 5 direct (antigen/RNA) tests for detection of acute infection and 6 indirect (antibody) tests for detection of prior infection that meet the recently published World Health Organization (WHO) "desirable" Target Product Profile (TPP) criteria.

The researchers hope their work will help communities and healthcare systems make more informed decisions when choosing rapid, point-of-care COVID-19 tests.

TPPs outline the desired characteristics of a product aimed at a specific disease. The WHO TPPs can be used to compare key features of COVID-19 tests and select products that best respond to the public health needs of each region.

The study, COVID-19 Point-of-Care Diagnostics That Satisfy Global Target Product Profiles, appears in the January 2021 issue of the journal Diagnostics, an international peer-reviewed, open-access journal published monthly by the Multidisciplinary Publishing Institute (MDPI).

The researchers screened more than 300 COVID-19 diagnostic tests that have obtained U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA), and more than 850 tests listed on the Switzerland-based Foundation for Innovative New Diagnostics (FIND) database.

From those tests, they analyzed two types of COVID-19 point-of-care (POC) tests: direct (antigen/RNA) tests to detect acute infection and indirect (antibody) tests to detect past infection.

Top Performing COVID-19 POC Tests
According to the study, the following COVID-19 POCTs met the WHO TPP "desirable" criteria for clinical sensitivity/specificity, limit of detection (LoD), 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
• Hangzhou Biotest Biotech RightSign COVID-19 IgG/IgM Rapid Test
• Hangzhou AllTest Biotech AllTest COVID-19 IgG/IgM Rapid Test
• NG Biotech NG IgG/IgM Rapid Test
• Sugentech SGTi-flex COVID-19 IgG
• VivaChek Biotech COVID-19 IgM/IgG Rapid Test

 
NSF International is an independent, global public health organization. NSF's health sciences services include training and education, consulting, clinical research, international regulatory guidance, corporate compliance, testing methods validation, and, separately, auditing, QMS (ISO 13485), GMP and GLP analytical testing, certification and R&D for the pharma biotech, medical device, dietary supplement and bottled water/beverage industries throughout the product lifecycle. In addition, NSF has CRO capabilities to help bring COVID-19 IVDs to market.

Novateur is an established global life science advisory with extensive experience related to business development and product development of therapeutics, medical devices and digital health products.