Lomina Strep A throat swab test

The Lomina Strep A Test is a rapid test that qualitatively detects the presence of Strep A antigens in throat swab samples and provides results within 5 minutes. The test uses antibodies specific for whole-cell Lancefield group A streptococci to selectively detect Strep A antigens in throat swab samples. If you have a sore throat and the rapid test comes out positive for Strep A, you definitely need to see a doctor!

Intended Use:

The Lomina Strep A Test is a rapid chromatographic immunoassay test designed for the qualitative detection of Strep A antigens from throat swab samples to aid in the diagnosis of group A streptococcal infection.

Strep A rapid test

The Lomina Strep A Test is a qualitative membrane immunoassay for the detection of Strep A carbohydrate antigen in throat swabs. The membrane is pre-coated with anti-StrepA antibody in the test area. During testing, the sample reacts with the anti-StrepA coated particle. The mixture of sample and reagents migrates across the membrane where an immunochemical reaction occurs during capillary migration and reacts with the anti-StrepA on the membrane to form a colored band. The presence of the coloured band in the test area indicates a positive result, while its absence indicates a negative result. As a check on the procedure, a colored band always appears in the control area, indicating that the correct volume of sample has been added and membrane activation has occurred.

Available Packaging Variants:

Usable Biological Material:

The test was developed and tested for the detection of Strep A in throat swabs.

Throat swab

Major Parameters, Characteristics & Limits

Test duration: 10 min

IVD category: IVD other

Sensitivity: 95.10% (95%CI: 89.60%-98.20%)

Specificity: 97.80% (95%CI*: 95.80%-99.99%)

Accuracy: 97.10% (95%CI*: 95.30%-98.40%)

Interpretation:

A. Negative test result:

A single coloured line appears in the control area (C). No coloured line appears in the test area (T).

B. Positive test result:

Two coloured lines appear. One colour line should be in the control area (C) and the other colour line should be in the test area (T). The intensity of the colour in the test area (T) will vary depending on the concentration of Strep A present in the sample. Therefore, any shade of colour in the test area (T) should be considered positive.

C. Invalid test result:

The control line is not displayed. The most likely cause of control line failure is insufficient sample volume or incorrect procedures. Check the procedure and repeat the test with a new cartridge. If the problem persists, stop using the test kit immediately and contact your local distributor.

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Instructions for use (IFU)

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CE Certificate

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High sensitivity and specificity of tests

Quick test
evaluation

Tested in accredited laboratories

Simple
application

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