About DIAKEY COVID-19 Antigen Rapid Test Kit
Intended use
The DIAKEY COVID-19 Ag Rapid Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider.
Principle of the assay
The DIAKEY COVID-19 Ag Rapid Test is based on the principle of the double antibody-sandwich technique to detect the presence of the nucleocapsid protein of SARS-CoV-2. When the test specimen is applied to the specimen well(S), a specimen migrates upward by capillary action. The SARS-CoV-2 antigens if present in the specimen will react with anti-SARS-CoV-2 antibody making an immune complex. The complex is then captured on the pre-coated anti-SARS- CoV-2 antibody making antigen-antibody color particle complex, and a visible colored line will show up in the test line region indicating a positive result.
Test Procedure
Result Interpretation
Clinical Performance
For the evaluation of diagnostic performance, 68 positive and 90 negative COVID-19 specimens were tested by the DIAKEY COVID-19 Ag Rapid Test. The sensitivity and specificity of the DIAKEY COVID-19 Ag Rapid Test was compared to an approved molecular assay.
Storage and Stability
Store as packaged in the sealed pouch at temperature (4 to 30°C or 40 to 86°F).
The kit is stable within the expiration date printed on the labeling.
Once open the pouch, the test should be used within one hour.
Prolonged exposure to the hot and humid environment will cause product deterioration.
Once open the pouch, the test should be used within one hour.
Prolonged exposure to the hot and humid environment will cause product deterioration.
Package and Order Information
Materials Provided
1.Device
2.Sterilized Swab
3.Package insert
4.Extraction Buffer Tube
5.Nozzle Cap
Distributed by Arey Solutions Sdn Bhd
Since 2018, Arey Solutions is focusing on distribution of medical supplies and providing radiation services to whole medical ecosystem in Malaysia.
On 2020, Arey Solutions Sdn Bhd has been appointed as the sole distributor for DIAKEY products from Shin Jin Medics Inc for Malaysia market.
On February 2021, Arey Solutions Sdn Bhd have received approval & recommendation letter from Medical Device Authority, Kementerian Kesihatan Malaysia to import, distribute & sell the product DIAKEY COVID-19 Antigen Test Kit for the whole Malaysia.
