AllCheck – COVID-19 Ag
Antigen rapid test · 20 tests per box
In vitro immunochromatographic test that detects the SARS-CoV-2 nucleocapsid protein in nasopharyngeal swab samples. Sensitivity 97.5%, specificity 100%, result in 10–15 minutes. Professional use and home testing.
In vitro diagnostic medical device — professional use and home testing
Description
AllCheck COVID-19 Ag is an in vitro diagnostic test that identifies the presence of the COVID-19 antigen (SARS-CoV-2 nucleocapsid protein) in nasopharyngeal swab samples by the immunochromatographic method, as an aid in the diagnosis of coronavirus infection. Manufactured in Korea by CALTH Inc.
The test cassette carries a control line (C) and a test line (T) on a nitrocellulose membrane. When the sample is applied, it moves along the conjugate pad, mobilises the gold conjugate and reacts with the antigen region: if the COVID-19 antigen is present, a coloured band forms in the test region; if not, the region stays uncoloured. The control line turns red or purple to show that the test has run correctly. The test is intended for professional use and for home testing, according to the instructions for use.
- Sensitivity 97.5%; specificity 100%
- Result in 10–15 minutes
- No additional reagents or further processing; visual reading of the result
- Shelf life 18 months; storage between 1 °C and 30 °C
Box contents. 20 individually sealed test cassettes, 20 sealed extraction buffer tubes, 20 filter caps and 20 sterile swabs for nasopharyngeal sampling.
Limitations (from the Romanian instructions for use). Test performance depends on the amount of antigen in the sample. False negative results are possible if the sample is collected, transported or handled incorrectly; samples should be tested as soon as possible after collection. A positive result does not rule out co-infection with other pathogens; a negative result does not rule out other viral or bacterial infections.
Intended use
- Medical practices and clinics
- Laboratories and point-of-care testing
- Home testing
Frequently asked questions
What does a valid test look like?
The control zone turns red or purple, showing that the test has run; a coloured band in the test region means the antigen was detected.
Does a negative result rule out infection?
No. The instructions state that false negatives are possible with incorrect sampling or handling, and a negative result does not rule out other infections.
Who may perform the test?
The test is intended for professional use and for home testing, following the manufacturer's instructions for use. In professional settings, sampling and interpretation are carried out by qualified medical staff.
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