Dejavu Medikal

Covid-19 Rapid Test Kit

INTENDED USE

The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum, or plasma as an aid in the diagnosis of primary and secondary SARS-CoV-2 infections.

Dejavu Medikal
Dejavu Medikal
Dejavu Medikal
PRINCIPLE

The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 antibodies in whole blood, serum, or plasma. This test consists of two components, an IgG component and an IgM component. In the IgG component, anti-human IgG is coated in IgG test line region. During testing, the specimen reacts with SARS-CoV-2 antigen-coated particles in the test cassette. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in IgG test line region. If the specimen contains IgG antibodies to SARS-CoV-2, a colored line will appear in IgG test line region. In the IgM component, anti-human IgM is coated in IgM test line region. During testing, the specimen reacts with anti-human IgM. IgM antibodies to SARS-CoV-2, if present in the specimen, reacts with the anti-human IgM and the SARS-CoV-2 antigen-coated particles in the test cassette, and this complex is captured by the anti-human IgM, forming a colored line in IgM test line region.

Therefore, if the specimen contains IgG antibodies to SARS-CoV-2, a colored line will appear in IgG test line region. If the specimen contains IgM antibodies to SARS-CoV-2, a colored line will appear in IgM test line region. If the specimen does not contain antibodies to SARS-CoV-2, no colored line will appear in either of the test line regions, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

Dejavu Medikal

PRODUCT CONTENTS

The test cassette contains to specific antigen conjugated gold colloid particles and anti-human IgM, anti-human IgG coated on the membrane.

Quick Result

Rapid Diagnostic Kit 5-10 min. it gives quick results in it.

%98,89 Precision Ratio

The test result will be 98,89% accurate.

Approved by the Ministry of Health

T.R. It is a sales kit approved by the Ministry of Health.

WARNINGS AND PRECAUTIONS
  • For professional in vitro diagnostic use only. Do not use after expiration date.
  • For single use only.
  • Apply the specimen dropping right exactly into specimen well (S) carefully to be sure that all specimen is transferred into strip inside the cassette.
  • Use micropipette for adding of specimen to dispense exact amount of specimen.
  • Do not eat, drink, smoke, or apply cosmetics where immunodiagnostic materials are being handled and tests are being performed.
  • Do not pipette by mouth.
  • Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens.
  • The used tests, specimens and potentially contaminated material should be discarded according to the local regulations.
  • Wear protective clothing such as laboratory coats, disposable gloves, and eye protection when specimens are assayed.
  • Humidity and temperature can adversely affect results.
  • After bringing the pouch (containing the test kit) to room temperature, use the test cassette within one hour of removal from the pouch at a relative humidity of ≤ 60% .
    • Documents (PDF)
    CATALOG USER GUIDE

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