Caveat emptor: Nearly half of rapid test kits approved by FDA not endorsed in China or US

Nearly half of the 39 rapid antibody test kits approved by the Food and Drug Administration (FDA) do not have the required regulatory approval from China and the United States.

This was revealed by a Politiko source who noted that one of the RTKs, onsite covid 19 by CTK Biotech, which claims to be Made in USA but is actually produced by a Chinese firm, is neither approved by the United States FDA or National Medical Products Administration (NMPA), China’s FDA.

Based on its guidelines, FDA is supposed to approve RTKs that were approved by foreign regulatory agencies in their home countries:

1) List of nucleic acid reagent test kits for COVID-19 approved by NMPA

2) Emergency use approval from the US-FDA

3) Emergency use approval from Korea Centers for Disease Control and
Prevention or Ministry of Food and Drug Safety from Korea

4) Provisional Authorization from Health Sciences Authority of Singapore

5) Therapeutic Good Administration (TGA) letter of inclusion from Australia

A quick scan of 39 RTKs approved by FDA showed that most of them did not meet this criteria. Aside from Onsite COVID-19 by CTK Biotech, other RTK products approved by FDA without US-FDA or China’s NMPA registration are:

1) Hangzhou Alltest Biotech Co. Ltd
2) Qingdao Hightop Biotech
3) Diagnosure COVID-19 by Hangzhou Biotest Biotech
4) Bioscience Chongqing
5) Zybio Inc.
6) Healgen Scientific Ltd
7) Zheijang Orient Gene Biotech
8) Maglumi 2019 NCOs by Shenzen New Industries Biomedical

9) VivaDiag by Vivachek Biotech Hangzhou
10) Shanghai Outdo Biotech
11) Beijing Lepu Medical Technology
12) Hecin Scientific Inc.
13) Shanghai Kehua Bio-Engineering
14) Diagnosure by Hengzhou Biotest Biotech Co.
15) Ortho Clinical Diagnostics
16) Medical System Biotechnology Co.
17) Clongene by Hangzhou Clongene Biotech co.
18)Wantai Sars-Cov by Beijing Wantai Biological

China is the biggest producer of PCR (Polymerase chain reaction (PCR) tests and RTKs in the world and its NMPA has endorsed only 23 firms that can export their products. Of these NMPA-endorsed firms, five Chinese RTKs were accredited by FDA:

1) Guangzhou Wondfo
2) Innovita Biological Technology Co. Ltd.
3) Guangdong Hecin
4) Vazyme Biotech Co. Ltd.
5) Zhuhai Livzon Diagnostics Ltd.

Source: Latest Politics News Today (Politics.com.ph)