Manufacturers of Serological Based Testing Kits: Submission Form
National Biomedical Resource Indigenisation Consortium NBRIC was constituted by the Department of Biotechnology, Ministry of Science and Technology, Government of India as a Public Private Partnership to drive indigenous innovation focused on developing reagents, diagnostics, vaccines and therapeutics for COVID19.
NBRIC is announcing a Mapping of the manufacturing capacity of COVID-19 Serological Based Testing Kits and the corresponding demand for reagents and consumables.
NBRIC will convey this information to government agencies or organisations that are in need of these and who may in turn connect with you. This information will also form part of a ready repository of companies that can provide these when required.
Data Privacy: Information submitted using this form will be shared with Government of India departments/organisations/private companies/institutes/diagnostic labs for the purpose stated above, as well as be made available in the public domain or the NBRIC Portal; however, if you have any concerns, kindly write to us at nbric[at]
ccamp.res.in
.
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Email address
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Your email
Company/Organization Name
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Your answer
Company/Organization Address
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Your answer
City/Town
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Your answer
State
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Your answer
Name
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Your answer
Designation
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Present designation in the company/organization
Your answer
Which testing kit are you manufacturing?
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ELISA
Rapid Diagnostic (LFA)
Both
Other:
What stage is your Testing Kit at?
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In developmental stage
Approved by regulatory bodies
Which approvals have you obtained:
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Test Kit approval from ICMR
Marketing approval from CDSCO
Manufacturing approval from CDSCO
CDSCO approval for outsourced manufacturing partner
US FDA
CE
Other:
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How many Serological based test kits can you manufacture in a month
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Your answer
This is equivalent to how many samples tested per month (1 test = 1 sample)
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Your answer
Specificity and sensitivity of the serology assay/kit. (Specificity and sensitivity in percentage)
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Please mention the specificity and sensitivity in terms of percentage
Your answer
Please mention the serology assay throughput and time required to complete the tests.
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Your answer
Please mention the matrix compatibility (serum, plasma, cell lysates, culture media, etc.)
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Your answer
Reagents that are required by your company: Antigen and Specify the Name of the Antigen S, N or RBD Protein (Please do not input only numbers. Specify your quantities in Units or Tests for example 1000 tests/ 1000ml/1000mg etc.)
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Quantity required per month in Tests or Units e.g. Litre, mL, gm, mg, Kg, Kits, Units; please mention units
Your answer
What is the purity of antigen (COA)?
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Your answer
Antibody (Anti human IgG) - HRP or Alkaline Phosphatase (Please do not input only numbers. Specify your quantities in Units or Tests for example 1000 tests/ 1000ml/1000mg etc)
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Quantity required per month in Tests or Units e.g. Litre, mL, gm, mg, Kg, Kits, Units; please mention units
Your answer
Antibody (Anti human IgM) - HRP or Alkaline Phosphatase (Please do not input only numbers. Specify your quantities in Units or Tests for example 1000 tests/ 1000ml/1000mg etc)
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Quantity required per month in Tests or Units e.g. Litre, mL, gm, mg, Kg, Kits, Units; please mention units
Your answer
Is your antigen tagged? (e.g. His Tag, Fc Tag, etc.). Please specify.
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Your answer
Positive Control Specify what Positive Control you have (Please do not input only numbers. Specify your quantities in Units or Tests for example 1000 tests/ 1000ml/1000mg etc)
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Quantity required per month in Tests or Units e.g. Litre, mL, gm, mg, Kg, Kits, Units; please mention units
Your answer
Negative Control : Specify what Negative control you have and the origin of the negative control (Please do not input only numbers. Specify your quantities in Units or Tests for example 1000 tests/ 1000ml/1000mg etc)
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Please mention the origin of negative control and the quantity in tests or units
Your answer
Protein A (Please do not input only numbers. Specify your quantities in Units or Tests for example 1000 tests/ 1000ml/1000mg etc)
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Quantity required per month in Tests or Units e.g. Litre, mL, gm, mg, Kg, Kits, Units; please mention units
Your answer
Substrate (Please do not input only numbers. Specify your quantities in Units or Tests for example 1000 tests/ 1000ml/1000mg etc)
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Quantity required per month in Tests or Units e.g. Litre, mL, gm, mg, Kg, Kits, Units; please mention units
Your answer
Colloidal Gold Conjugate (Please do not input only numbers. Specify your quantities in Units or Tests for example 1000 tests/ 1000ml/1000mg etc)
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Quantity required per month in Tests or Units e.g. Litre, mL, gm, mg, Kg, Kits, Units; please mention units
Your answer
Stop Solution (Please do not input only numbers. Specify your quantities in Units or Tests for example 1000 tests/ 1000ml/1000mg etc)
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Quantity required per month in Tests or Units e.g. Litre, mL, gm, mg, Kg, Kits, Units; please mention units
Your answer
Any other reagents used in COVID-19 Serological based Testing Kit and not mentioned in the above list, please list them below
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Quantity required per month in Tests or Units e.g. Litre, mL, gm, mg, Kg, Kits, Units; please mention units
Your answer
To double your monthly output of test kits, which reagents/consumables are you falling short of?
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List all ; specify units e.g. Litre, mL, gm, mg, Kg, Kits, Units
Your answer
Any other challenges related to manufacturing capacity expansion. List all
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Your answer
A copy of your responses will be emailed to the address you provided.
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