CORONAVIRUS INFORMATION

SARSCOV-2 RAPID TESTSARSCOV-2 RAPID TEST

AN EFFECTIVE SCREENING

POINT-OF-CARE TEST

When the body has been exposed to the SARS-CoV-2 virus, it produces IgM and IgG antibodies in an attempt to defend itself against infection. By measuring the concentration of these particular antibodies, the SARS-CoV-2 Rapid Test can determine in 20 minutes whether you have been exposed to the virus within the past 4 to 24 days or even longer ago.

The test kit is for single use only and is disposable.

RELIABLE RESULTS

The appearance of a purplish-red line at the IgM line alone indicates the presence of the IgM antibody, suggesting an early infection stage (within the past 4 to 10 days).

A purplish-red line appearing at the IgG line (alone or in addition to IgM) indicates the presence of IgG, suggesting a later infection phase (within the past 11 to 24 days or a past infection longer ago).

Even the slightest staining of the test lines means a positive result.

A visible purplish-red line must appear in the control region “C” for the test results to be valid.

Negative compliance rate

99,8% conformance rate (specificity) for 272 negative controls with subjects not infected with SARS-CoV-2.

Positive compliance rate sensitivity

Early infection stage (day 4-10):       IgM70.0%

Late infection stage (day 11 – 24):  IgM 92.3%

Late infection stage (day 11 – 24):    IgG 98.6%

APPLICATION OF THE

“CoV-2 RAPID TEST” KIT

The test should be performed by a health care provider.

The test is very simple.  Two drops of blood are taken from a patient’s fingertip and placed in the specimen window of a test cassette, along with two drops of buffer solution. Results are available in 20 minutes.

If only the control band (“C”) has a purplish-red line, no antibodies were detected and the patient most likely has not been infected.  If no line appears at “C”, the test is invalid and must be performed again with a new kit.  If a purplish-red line (even a faint one), appears at the IgM line, the patient is likely in an early stage of infection (4-10 days).  If a purplish-line (even a faint one) appears at the IgG line,  the patient is likely in a later stage of infection (11-24 days, or longer).

The evaluation is based on the following graph, which illustrates the course of the COVID-19 infection:

kit

Video

041720 IFU CoV-2 Rapid Test - EN - EUROPE - V3.61
200414_BfArM_Sonderzulassung_Anschreiben_V1.04_Full Document_sign
CORONA VIRUS TEST KIT. USER MANUEL IN CC