CoVard COVID-19 Hızlı Antijen Test Kiti
Transcript of CoVard COVID-19 Hızlı Antijen Test Kiti
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