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Test report

Test Report

The COVID-19 IgM/IgG Antibody {IgM/IgG) Combined Test is a qualitative, lateral flow immunoassay for the detection of IgM&IgG antibody to SARS-CoV-2 in human serum, plasma or whole blood. In this test, a monoclonal anti-human IgM antibody and a monoclonal anti-human IgG antibody is separately coated on the test line regions of the test device. During testing, the specimen reacts with the SARS-CoV-2 recombinant antigens that are labeled onto latex particles. The mixture migrates up the membrane to react with the antibodies to human IgM and/or human IgG on the membrane and generate one or two colored lines in the lest regions. The presence of this colored line in either or both of the test regions indicates a positive result. To serve as a procedural control, a colored line will always appear in the control region if the test has performed properly.

ANALYSIS METHOD

Refer to the reference range and test results of the clinical diagnostic results, divide all
above
clinical specimens to two groups: normal group and nonnormal group. In the
nonnormal group, count the number of positive result as the True Positive (Abbr. as TP)
and the number of negative result
as the False Negative (Abbr. as FN); In the normal
group
, count the number of positive result as the True Negative (Abbr. as TN) and the
number of negative result as the False Positive (Abbr. as FP),
The clinical sensitivity is calculated according to the following formula:
The clinical specificity is calculated according to the following formula:
K value is calculated by SPSS 19.0.

RESULT

A total of 300 samples of 703 cases were tested in this clinical study. Among the SOOsamples, a total of 40 samples from 19 cases with incomplete information or repeated test are excluded. As a result, 760 samples from 689 cases were included in the statistics.
Details are listed in the below.

Result Analysis

The sensitivity is 97.90 %, the specificity is 91.77% and the total consistent is 94.08%.
The K value of Kappa analysis is 0,877, which means the test results of the kit are inreasonable comparability with the confirmed / excluded results.

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