About Us Tenders

EOI: Indian Council of Medical Research- COVID-19 testing

Posted on: April 11, 2020 | Back | Print

Indian Council of Medical Research, Department of Health Research, Government of India New Delhi invites techno-commercial offer for procurement of following items related to COVID-19 testing.

Specifications:
Viral RNA Extraction
-Kit should work with silica membrane column / magnetic bead-based technology
allowing extraction of Viral RNA From Human Samples (Plasma, CSF, Urine, Other
cell-free body fluids and Cell-culture supernatants.
-The Viral RNA extracted using this kit should be used for downstream applications
like PCR, qPCR, real-time PCR
- Kit should extract Viral RNA using sample volume between 100μl - 200μl and
Elution volume between 40 μl - 80 μl
-The process of extraction using the kit should be either centrifugation/vacuum
based/magnetic bead based.
-Carrier RNA should be used in the kit to capture maximum amount of the Viral RNA
from sample and carrier RNA Should help viral RNA to escape from degradation by
RNases
- Time per extraction should be 30-60Min
- Yield of the Viral RNA should be >90% recovery
- The Elution buffer should have necessary components to prevent microbial growth
and contamination with Rnases.
- Should be optimized for use with biological fluids and cell-free samples such as
serum, plasma, swabs, and cell culture medium.
- The extraction kit should be able to work on manual as well as automated platform
both.
RT-PCR Kits for COVID-19
- Should be approved by European CE-IVD or US-FDA
- If not approved by CE-IVD/US-FDA, validation by ICMR Institutes such as NIV
Pune is mandatory.
- Company should have obtained marketing licence for RT PCR test kits from Drug
Controller General India.
- Real time PCR test protocol with fluorescent probe based chemistry.
- Compatible for multiple RT- PCR platforms
- Compatible with different viral RNA extraction kits available in the market.
- Test should be based on at least two viral gene targets along with internal control
which validates sample quality, RNA extraction and RT PCR reaction.
a. Screening Assay : Gene specific for sub genus Sarbeco + Internal Control
b. Confirmatory assay : One or more gene targets specific to SARS CoV-2
Antibody IgM and IgG Rapid Test Kit for COVID-19
- Should be approved by European CE-IVD or US-FDA
- If not approved by CE-IVD/US-FDA, validation by ICMR Institutes such as NIV
Pune is mandatory.
- Company should have obtained marketing licence for Rapid test kits from Drug
Controller General India.
- The kits should be able to differentiate IgM and IgG separately for COVID-19.
Viral Transport Medium
- 10-15 ml volume screw-cap, leak-proof tube
- Two sterile synthetic fiber swabs ( polyester, rayon, or dacron) with plastic shafts or
Wire shaft (flexible shaft): In general ICMR recommends two swabs i.e. NP and OP
specimens should be combined at collection into a single vial.
- Should contains 3 ml of viral transport media
- 1 Ziplock specimen bag containing absorbent pad
- Labeling stickers
- It should be in the volume of 3ml viral transport medium in 10-15 ml centrifuge tube.
- It should contain a protective protein antibiotics to control microbial contamination
and buffers to control the pH.
- The medium also contains a cryoprotectant which helps in preserving the viruses, if
specimens are frozen for prolonged storage.
- The medium should be stable at room temperature.
- pH 7.3 +- 0.3.
- Osmolality in mOsm/Kg H2O 500.00 - 600.00


Interested suppliers may submit their quotations through the email head.rbmh@gmail.com AND sharmav1.del.cca@gov.in by 14th April, 2020 not later than 02:30 PM Indian Standard Time.

CORRIGENDUM 12 Apr 2020

" 1. DCGI permission is not a precondition and may be submitted before delivery.
2. The certification of US-FDA, CE-IVD is desirable. However the CE from  the country of origin will also be considered subject to approval by  ICMR.
Other terms and conditions will remain same."

https://icmr.nic.in/sites/default/files/upload_documents/EOI_Specifications_Corrigendum_VTM.pdf | https://icmr.nic.in/sites/default/files/upload_documents/EOI_Specifications_Corrigendum_VTM.pdf

Please find attached document for more details.