SARS-CoV-2 N-Protein Antigen Rapid test (Immunofluorescence)

The kit is used for the qualitative detection of new coronavirus SARS-CoV-2 nucleocapsid (N) antigen in human Oro and Nasopharyngeal swab samples in vitro (pharyngeal swab fluorencence assay)

Intended Use:

 The kit is used for the qualitative detection of new coronavirus SARS-CoV-2 nucleocapsid (N) antigen in human Oro and Nasopharyngeal swab samples in vitro.

It is used as a supplementary detection indicator for suspected cases of new coronavirus negative nucleic acid detection or used in conjunction with nucleic acid detection in the diagnosis of suspected cases. It cannot be used as a 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 for  the use of nasopharyngeal or oropharyngeal swab samples.

Nasopharyngeal

Oropharyngeal

Major Parameters, Characteristics & Limits

Sensitivity: 91,29% (CI 95%: 87,73%-94,09%)

Specificity: 98,61% (CI 95%: 97,99%-99,01%)

Interpretation:

1. 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 test:

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 invalid result. Contact your local distributor if the problem continues. (picture C). 

ALTERNATIVELY, USE LSLC-20 DETECTOR TO READ THE RESULTS

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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