Company Checklist for Rapid COVID Tests

Contact details

Company name

Company website

Product name

Product objective (i.e. Antigen test or Anti-body test)

If Anti-body test, please specify what you are testing for; gA, IgG, IgM

Person completing document

Contact email

Has your test been part of the Porton Down - Oxford University study?

If yes, which phase of validation has it reached?

Validation protocol

Reference standard/test used

Type of specimen used

Delay between sample collection & test execution

Number of days since symptom onset

Were asymptomatic cases tested? (please specify number)

Number of subjects enrolled

Number of people tested

Genders

Age ranges

Ethnicity/ies

Prevalence of tested population

Is the study internal-corporate / sponsorship funded / independent

Reported Performance of Test

Could you please provide the information needed to create a 2x2 table for (i) symptomatic people and (ii) Asymptomatics

Symptomatics - Gold standard test (e.g. PCR)

COVID Positive

COVID Negative

Symptomatics - Your rapid test

COVID Positive

COVID Negative

Asymptomatics - Gold standard test (e.g. PCR)

COVID Positive

COVID Negative

Asymptomatics - Your rapid test

COVID Negative

COVID Positive

Regulatory Status

Please specifiy the regulatory approval/s your test has received

Is your test on the World Health Organisation Emergency Use Listing?

Is your test approved / regulated for use in the United Kingdom?

Technical support

Do you possess an app to support an individual "passport" of test results?

What technical support does your company provide?

What technical support is not provided?

Manufacturing & Further Evidence of Quality

What other range of products are offered by your company (especially, lateral flow tests for other diseases)

What regulatory approvals do you have for non-emergency diagnostic products?

Shipping & Storage

What is the target shelf life at 30° to 40°C?

Specimen Collection Requirements

Specimen type

Number of processing steps

Time to perfom 1 individual test (including set up time, specimen collection + analysis to reporting time)

Processing time for multiple testing. How long to test a squad of 30 players?

How are results displayed?

Is training required to perform the test?

Is calibration required? If so, how often and how long?

Contents of test kit

What is not provided in the test kit but essential to carrying out testing?

Cost of the Test

Cost of testing unit/machine (GBP £)

Cost per test (GBP £)

Additional costs (GBP £)

Please read before submitting your information

“Thank you for providing the [above] information for the purposes of the club assessing the suitability of your company’s proposed supply of goods/services.

By providing this information, you confirm that you have any necessary rights and permissions for you to do so. You also acknowledge that if we elect (in our sole discretion) to discuss your proposal and/or submitted material further, this does not constitute an offer by us to procure any goods and/or services from you, or give rise to any right for you to receive any form of remuneration or other compensation from us in connection with such discussions (which will be subject to you and us entering into a full written contract). You agree to keep any such discussions strictly confidential.”

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