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Lomina SARS-CoV-2 Antigen LTX Selftest is a test kit designed for home use by lay persons for qualitative detection of the new coronavirus nucleocapsid (N) antigen in self-collected human nasal swab samples in vitro.

Intended Use:

Lomina SARS-CoV-2 Antigen LTX Selftest is a test kit designed for home use by lay persons for qualitative detection of the new coronavirus nucleocapsid (N) antigen in self-collected human nasal swab samples in vitro. It is used as a supplementary detection indicator for suspected cases of new coronavirus designed for virus detection from approximately 5th day after infection including asymptomatic cases. It should not be used as the only basis for the diagnosis and exclusion of pneumonitis caused by the new coronavirus. Lomina SARS-CoV-2 Antigen LTX Selftest is intended for self-testing of all age groups for adults or under adults supervision. Patients with limited abilities shall ask an assistance of a professional or for this purpose trained person.

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Available Packaging Variants:

Usable Biological Material:

The test is developed and tested for the use of nasopharyngeal or oropharyngeal samples.

Nasal swab

Major Parameters, Characteristics & Limits

Sensitivity: 97,04% (95% CI: 94,99% – 98,41%)

Specificity: >99,80% (95% CI: 99,29% – 99,98%)

 

Interpretation:

1. SARS-CoV-2 (COVID-19) Positive:

One band/line appears in the control region “C”, and another band/line appears in the “T” region (picture A).

2. Negative test:

Only one band/line appears in the control region “C” with no other bar sign elsewhere (picture B). 

3. Invalid result:

No band/line appears in the control region (C), whether a test band “T” is present or not. Repeat invalid tests with a new sample, new test device and reagent. Insufficient sample volume, inaccurate operating procedure or expired tests may yield an invalida result. Contact your local distributor if the problem continues. (picture C).  

Downloads:

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Instructions for use (IFU)

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Certificate of Conformity

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High sensitivity and specificity of tests

Quick test
evaluation

Tested in accredited laboratories

Simple
application

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