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CoVard COVID-19 Hızlı Antijen Test Kiti

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CoVard COVID-19 Rapid NasalAntigen Test Kit

CoVard Covid-19 Rapid Antigen (Ag) Test is a lateral flow sandwich test

designed for qualitative detection of nucleocapsid protein antigen directly

from SARS-CoV-2 in nasal swabsamples.

CoVard COVID-19 Rapid NasalAntigen Test Kit

Assay Format

Test Type

InstrumentSample Type

Target Antigen

Readout Time

Sensitivity

Specificity

Storage Temperature 2 – 30 °C

%99,6

%97,57

15 Minutes

Nucleocapsid (N)

Nasal

Device-free

QualitativeLateralFlowTest

Instant Virus Antigen Detection

Ultra Fast

High Specificity and Sensitivity

CE-IVD Certificated

%100 Domestic Production

Storage at room temperature

For Professional In Vitro Diagnostic Use.

Materials Providedwith Test Kits:

Test CassettesSample Collection andLysis TubesSwabsDropper CapSilica Gel User Guide

Sensitivity and SpecificitySamples from 605 RT-PCR-identifiedpositive patients were processed withthis test kit and 603 samples wereidentified as positive; on the other hand,513 samples were detected as negative insamples taken from 498 RT-PCR-identified negative patients.

PCR TotalResultResult Positive Negative

Positive 603 2 605Negative 15 498 513

Total Result 618 500 1118

Sensitivity: 608/618 97.57% (95% CI: 95.82%-98.51%)Specificity: 498/500 99.6% (95% CI: 97.81%-99.69%)

AG+ AG-

Positive Negative InvalidPositive Result

If both the (C) and (T) lines become visible within 15 minutes, the test result is

positive and valid.

Negative ResultIf the test area (T)

line has no color and the control area

shows a colored line, the result is negative

and valid.

Invalid ResultIf a colored line does not

appear in the control region (C), the test

result in invalid. The test must be repeated

using a new test casette.

Interpretation of Test Results