Lomina SARS-CoV-2 Antigen LTX Test (saliva)

The kit is used for the qualitative detection of new coronavirus nucleocapsid (N) antigen in human saliva samples in vitro.

Intended Use:

 The kit is used for the qualitative detection of new coronavirus nucleocapsid (N) antigen in human saliva 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. 

Video

Available Packaging Variants:

Usable Biological Material:

The test is developed and tested for the use of saliva samples.

Saliva

Major Parameters, Characteristics & Limits

Sensitivity: 94,17% (95% CI: 90,82%-96,86%)

Specificity: 100% (95% CI: 98,82%-100%)

Interpretation:

 

The test results of the kit are to be only used for clinical auxiliary diagnosis, not as the only basis for clinical diagnosis. The test should be comprehensively judged in a combination with clinical symptoms and another detecting indicators.

Results is interpreted by presence of a visible strip the “T” area at the test card body /See picture bellow), the visual inspection results are following. 

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)

Negative test:

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

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 test may yield an invalid 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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