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High accuracy rapid Covid-19 test, manufactured in Germany

A: Not for current challenges

Rapid Test is a chromatographic lateral flow immunoassay for the qualitative detection of anti-SARS-CoV-2 IgG and IgM in human whole blood, serum or plasma samples. It is important to note that in the early stages of the infection (3 to 7 days after symptoms first appear), anti-SARS-CoV-2 IgG and IgM may be below the detection limit of the test. The test is intended as an aid in the diagnosis of primary infections and possible secondary infections with SARS-CoV-2. The test procedure is not automated and requires no special training or qualification. Reduce the high dependencies on lab based tests and significantly reduce the overall costs of testing. 

Have you validated this method, if so, how and what were the results of the validation?

Clinical performance

Diagnostic sensitivity and specificity IgG/IgM Test was evaluated using clinical specimens from patients with symptoms of pneumonia or respiratory infections in comparison with a PCR.

Diagnostic sensitivity: 93.7% (86.0% - 97.3%)*
Diagnostic specificity: 99.1% (96.8% - 99.8%)*
Overall agreement: 97.7% (95.4% - 98.9%)*
*95% confidence interval

How quickly could this be deployed and what are the dependencies?

Manufactured in Germany, it is available now, with high quality control. With high accuracy. Guaranteed fast delivery.

Supplied as:

 25 IgG/IgM Test cassettes
 25 disposable pipettes (5 μL)
 1 buffer (3 mL)
 1 package insert

The factory has sufficient capacity to meet high volume orders.

What is the likely production volume?

100,000 per day.

What are the risks and barriers to using this at scale?

The Rapid Test is for professional in-vitro diagnostic use only. It should be used for the qualitative detection of anti-SARS-CoV-2 antibodies in human whole blood, serum or plasma specimens only.

Neither the quantitative value nor the rate of increase in the concentration of anti-SARS-CoV-2 antibodies can be determined with this qualitative test.

The Rapid Test only detects the presence of anti-SARS-CoV-2 antibodies in specimens and
should not be used as the sole criterion for a diagnosis of COVID-19.

As with all diagnostic tests, all results should be interpreted in conjunction with other clinical information available to the physician.

At the beginning of the disease, the concentration of anti-SARS-CoV-2 IgM may be below the detection limit of the test.

The continued presence or absence of antibodies cannot be used to determine the success or failure of therapy.

Results from immunosuppressed patients should be interpreted with caution.

A positive test result can also occur in case of negative PCR results because antibodies are still present in the blood after the illness and can be detected.

If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of a SARS-CoV-2 infection.

A high-dose hook effect may occur where the colour intensity of test lines decreases as the concentration of anti-SARS-CoV-2 IgM/IgG increases. If a high-dose hook effect is suspected, the dilution of specimens may increase the colour intensity of test lines.

Who are you already partnering with on this?

Mecotec Germany

edited on May 18, 2020 by Gopal Jeyasundra
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Bev Matthews May 23, 2020

Hello Gopal, your solution has been reviewed by the assessors and feel that it doesn't quite fit for this challenge at the moment. Please do look out for future challenges and thank you for your submission. Bev

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Bev Matthews May 23, 2020

Status label added: A: Not for current challenges

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