Lomina SARS-CoV-2 Antigen LTX Test (nasopharyngeal / oropharyngeal swab)

The kit is used for the qualitative detection of new coronavirus nucleocapsid (N) antigen in human oropharyngeal and/or nasopharyngeal swab samples in vitro.

Intended Use:

The kit is used for the qualitative detection of new coronavirus nucleocapsid (N) antigen in human oropharyngeal and/or nasopharyngeal swab samples in vitro. It is used as a supplementary detection indicator for suspected cases of new coronavirus. It cannot be used as the only basis for the diagnosis and exclusion of pneumonitis infected by new coronavirus.  

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Available Packaging Variants:

Usable Biological Material:

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

Nasopharyngeal swab

Oropharyngeal swab

Major Parameters, Characteristics & Limits

Sensitivity: 94,17% (95% CI: 87,75% – 97,83%)

Specificity: 100% (95% CI: 98,54% – 100%)


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:

Document

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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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