Product

Seroscreening kit

What’s inside?

Each box includes 25 seroscreening kits, containing the test cassette, a one-use sterile lancet, a pipette to extract a drop of blood, an alcohol towelette and a small bottle of buffer solution.

How are they used?

The kits are simple to use: a health professional pricks the patient’s finger with a sterile lancet and discards the first drop of blood. They use the enclosed pipette to extract the blood and then deposit 2-3 drops of blood in the test well followed by two drops of buffer solution. Then they wait 15 minutes before reading the results. That’s how easy it is.

Seroscreeing SARS-CoV-2 kits should only be used by professional personnel. Protective systems should be in place to adequately protect the test takers from contagion.

Reading the results

After 15 minutes, the results can be read. Positive results, both for IgM or IgG, appear as a purple/red line. Because of the technology used, the line may be very faint, but should nevertheless be considered a positive result. The C control line must always be visible. Otherwise, the test should be considered invalid.

Actions

In the first, “baseline” round, the test indicates if the subject has been exposed to the virus but it does not determine how long ago the infection occurred (up to five weeks for IgM+).

In the second, or “precision” round, the appearance of a positive result which was negative in the first round is an indicator that the individual was infected in the past 10 days.

In the later control rounds, the objective is to confirm if all of the cases have been detected and isolated, and thus that there are no additional possible asymptomatic carriers.


Reliability

Linkcare has completed validation tests with Hospital NS de Meritxell in Andorra.

Combined
Validation details

Linkcare’s assays have also been validated by three different hospitals in China: Wuhan Hangyun Hospital, The First Affiliated Hospital of Guangzhou Medical University, and Third People’s Hospital Hubei Province.

Validation

Certificates

The kits have all the necessary certificates for their commercialization in the European Union. Their sensitivity and specificity have been validated both in Europe and in China.


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