Lomina SARS-CoV-2+ Influenza A/B Antigen LTX test

LOMINA SARS-CoV-2 + Influenza A/B Antigen Test is an antigen test kit designed for simultaneous qualitative detection of the SARS-CoV-2 and/or Influenza A/B infection in human nasal swab samples in vitro.

Intended Use:

LOMINA SARS-CoV-2 + Influenza A/B Antigen Test is an antigen test kit designed for simultaneous qualitative detection of the SARS-CoV-2 and/or Influenza A/B infection in human nasal swab samples in vitro. It is used as a supplementary detection indicator for suspected cases of SARS-CoV-2 causing disease COVID-19 and/or respiratory Flu infection A/B.

SARS-CoV-2+ Influenza A/B Antigen LTX Test :

The novel coronaviruses belong to the ß genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases. Influenza is a highly contagious, acute, viral infection of the respiratory tract. It is an infectious disease easily spreading through coughing and sneezing droplets containing live viruses. Type A viruses are typically more prevalent than type B viruses and are associated with most serious influenza epidemics, while type B infections are usually milder. Rapid diagnosis of influenza A/B has become more important due to the availability of effective antiviral therapy. Rapid diagnosis of influenza can reduce hospital stays, antimicrobial use and cost of hospital care

Available Packaging Variants:

Usable Biological Material:

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

Nasal swab

Major Parameters, Characteristics & Limits

Test duration: 15 min

IVD category: IVD other

COVID-19
Sensitivity: 97,04% (95% CI: 94,99%-98,41%)
Specificity: 99,80% (95% CI: 99,29%-99,98%)
Accuracy: 98,97 (95% CI: 98,31%-99,42%)

Influenza A
Sensitivity: 95,77% (95% CI: 88,14%-99,12%)
Specificity: >99,9% (95% CI: 98,46%-100%)
Accuracy: 99,03% (95% CI: 97,19%-99,80%)

Influenza B
Sensitivity: 95,12% (95% CI: 87,98%-98,66%)
Specificity: >99,9% (95% CI: 98,55%-100%)
Accuracy: 98,87% (95% CI: 96,97%-99,67%)

Principle:

The Lomina SARS-CoV-2 + Influenza A/B Antigen LTX test is a qualitative immunoassay for the detection of SARS-CoV-2 and/or Flu A/ B antigen in nasal swab specimens. Anti-SARS-CoV-2 antibody is coated in the test region of SARS-CoV-2. Anti-Influenza A antibody and anti-Influenza B antibody are coated in the test A region (A) and test B region (B) respectively. During testing, antigen in the specimen reacts with anti-SARS-CoV-2 antibody-coated particles and with anti-Influenza A antibody-coated particles as well as with anti-Influenza B antibody-coated particles in the reaction pad to produce the immune complex. The complex migrates along the membrane by capillary action to the test region. The complex then respectively reacts with the anti-SARS-CoV-2 antibody in the test region of SARS-CoV-2 and with anti-Influenza A antibody in the A region as well as with anti-Influenza B antibody in the B region. If the specimen contains SARS-CoV-2 antigen, a colored line will appear in the test region of SARS-CoV-2. If the specimen contains Influenza A/B, a colored line will appear in the test A/B region. If the specimen does not contain antigen of SARS-CoV-2, Influenza A/ B, no colored line will appear in the test region, indicating a negative result. To serve as a control, a colored line will always appear in the control region (C), indicating that the result is effective.

Interpretation:

A. Negative test result:

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

B. Positive test result:

One band/line appears in the control region „C“, and another band/line or lines appears in the „COV-2, Flu A or B“ region (picture A).

C. Invalid test result:

No band/line appears in the control region (C), whether a test bands „COV-2, Flu A or B“ are 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.

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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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