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COVID Antibody: Zydus Cadila gets nod for ICMR-NIV developed ELISA kit
New Delhi: In a major breakthrough, drugmaker Zydus Cadila has received validation from the National Institute of Virology (NIV), Pune for the first batch of indigenous anti-SARS-CoV-2A (Covid-19) human IgG ELISA test kit for antibody detection of the lethal virus.
As per the Indian Council of Medical Research (ICMR), ELISA Kit has a similar sensitivity of 98.7 percent and specificity of 100 percent. The kit is cost-effective, sensitive, rapid and a large number of samples can be tested at any level of a clinical setting, including public health centers and hospitals.
This comes days after the development of the technology at ICMR-NIV. The technology has been transferred to Zydus Cadila for mass production. Union Health Minister, Dr Harsh Vardhan confirmed the same through his social handle as;
#ELISA based testing is easily possible even at district level. The @icmr_niv technology has been transferred to #Zydus #Cadila for mass-scale production.
— Dr Harsh Vardhan (@drharshvardhan) May 10, 2020
The Drug Controller General has granted commercial production & marketing permission to Zydus. #COVID19Updates #SARS_CoV_2 pic.twitter.com/jFaAAerWtl
As per a recent IANS report, the Council is in the process of carrying out a national surveillance study with 24,000 individuals.
As of now, 42 antibody-based rapid tests have been validated, and the following were found to be satisfactory. 10 of these kits are manufactured in India.
S.No. | Kit Detail | Lot no./Batch no. |
1. | COVID-19 IgM IgG Rapid Test: BioMedomics (CE-IVD) | 20200226 |
2. | New Coronavirus (COVID-19) IgG/IgM Rapid Test: Voxtur Bio Ltd, India | PCCV200301S |
3. | COVID-19 IgM/IgG Antibody Detection Card Test: VANGUARD Diagnostics, India | RCOVID200301T |
4. | Make sure COVID-19 Rapid test: HLL Lifecare Limited, India | CVCT030420 CVCT0204203 CVCT0104202 |
5. | YHLO iFlash-SARS-CoV-2 IgM and IgG detection kit (additional equipment required): CPC Diagnostics | 20200206 |
6. | ACCUCARE IgM/IgG Lateral Flow Assay kit: LAB-CARE Diagnostics (India Pvt. Ltd) | CVC 200401 |
7. | Abchek COVID-19 IgM/IgG Antibody Rapid Test: NuLifecare | NUL/COV- 19/R&D/001 |
8. | One Step Corona Virus (COVID-19) IgM/IgG Antibody Test: ALPINE BIOMEDICALS | A10420 A20420 |
9. | COVID 19 IgM/IgG Rapid Test Kit; Medsource Ozone Biomedicals (ver 2.0) | COV-002 |
10. | Immuno Quick Rapid Test for Detection of Novel Coronavirus (COVID-19) IgM/IgG Antibodies: Immuno Science India Pvt. Ltd | E142001 |
11. | Standard Q COVID -19 IgM/IgG Duo test – One Step Rapid Antibody test: SD Biosensors | E054002 E054004 |
12. | COVID-19 IgG/IgM Rapid Test Kit Rafael Diagnostic: BMT Diagnostics | COV20030059 COV20030059-1 |
13. | One Step COVID-19 IgM/IgG Antibody: SIDAK Life Care Pvt. Ltd. | COVID19S004A COVID19S004B COVID19S004C |
Rapid antibody tests are not recommended for diagnosis of COVID-19 infection
-
ï‚· Can be done on blood/serum/plasma samples
-
ï‚· The test result is available within 30 minutes
-
ï‚· The test may come positive after 7-10 days of infection
-
ï‚· The test may remain positive for several weeks after infection
-
ï‚· A positive test indicates exposure to SARS-CoV-2
-
ï‚· A negative test does not rule out COVID-19 infection
These rapid antibody test kits have been validated in the laboratory. However, the performance of the kits may be subject to variation under field conditions. The above-listed kits are validated with the mentioned batch number only. Responsibility for the batch to batch, consistency lies with the manufacturer.
Guidance on rapid antibody kits for COVID-19
S.No. | Kit Detail | Lot no./Batch no. |
14. | SARS-CoV-2 Antibody test (Lateral flow method): Guangzhou Wondfo Biotech, Mylan Laboratories Limited (CE-IVD) Zydus Cadila | # W19500309 W19500302 W19500351 W19500338 |
15. | COVID-19 IgM/IgG Antibody Rapid Test: ZHUHAI LIVZON DIAGNOSTICS (CE- IVD) | # CK2003010410 |
# The marketing licenses to the distributors of these 2 companies have been canceled by the Central Drugs Standard Control Organization (CDSCO).
Antibody-based rapid tests which are CE-IVD approved
The complete list of CE-marked rapid SARS-CoV-2 antibody tests is available at (https://www.finddx.org/covid-19/pipeline/). CE-IVD approved kits can be used directly after due marketing approval from DCGI.
For the full details click on the following link:
https://medicaldialogues.in/pdf_upload/pdf_upload-128789.pdf
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751