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
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Can be done on blood/serum/plasma samples
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The test result is available within 30 minutes
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The test may come positive after 7-10 days of infection
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The test may remain positive for several weeks after infection
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A positive test indicates exposure to SARS-CoV-2
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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
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