DIAGNOSTIC KIT FOR COVID-19 ANTIGEN TEST
    Publish time 2021-10-06 21:58    
ANTIGEN TEST(COLLOIDAL GOLD)
[PRODUCT NAME]
Diagnostic Kit for COVID-19 Antigen Test(Colloidal Gold)
[PACKAGE SIZE]
25 Tests/Kit
[INTRODUCTION]
Since the COVID-19 pandemic, laboratories have been using nucleic acid amplification testing
(NAAT) to detect the SARS-CoV-2 virus that causes the disease, such as real-time reverse transcription
polymerase chain reaction (rRT PCR). It is challenging to use this method (rRT PCR) in many countries.
It is urgent to a rapid method for detecting SARS -CoV-2 antigen in respiratory secretions.
At present, different brands of antigen detection data show that the detection performance of antigen
detection reagents is relatively good in patients who are usually appear in the early symptomatic phases
of the illness (1-3 days after symptom onset and within the first 5-7 days of illness). This provides an
opportunity for early diagnosis and for blocking transmission by targeted isolation and concentration
of the most infectious patients and their close contacts. Patients who present more than 5-7 days after
the onset of symptoms may have lower viral load, which may lead to false negative results of antigen
detection reagents.
[INTENDED USE]
The kit is a rapid chromatographic immunoassay for the qualitative detection of specific antigens to
SARS-CoV-2 present in human nasopharynx. This test is for administration by healthcare workers
and laboratory professional only, as an aid to early diagnosis of SARS-CoV-2 infection in patient with
clinical symptoms with SARS-CoV-2 infection. It provides only an initial test result. This product is
strictly for medical professional use only and not intended for personal use. The administration of the test
and the interpretation of the results should be done by a trained health professional. The result of this test
should not be the sole basis for the diagnosis; confirmatory testing is required.
[PRINCIPLES OF PROCEDURE]
Diagnostic Kit for COVID-19 Antigen Test (Colloidal Gold) has two pre-coated lines, “C” control
line, “T” test line on the surface of the nitrocellulose membrane. Anti-SARS-CoV-2 antibody is
coated on the test line region and anti-chicken IgY antibody is coated on the control line region.
Anti-SARS-CoV-2 antibody conjugated with color particles are used as detectors for SARS-CoV-2
antigen device. During the test, SARS-CoV-2 antigen in the specimen interact with monoclonal
anti-SARS-CoV-2 antibody conjugated with color particles making antigen-antibody color particle
complex. This complex migrates on the membrane via capillary action until the test line, where it
will be captured by the anti-SARS-CoV-2 antibody. A colored test line would be visible in the result
window if SARS-CoV-2 antigens are present in the specimen. The intensity of colored test line
will vary depending upon the amount of SARS-CoV-2 antigen present in the specimen. If SARS
CoV-2 antigens are not present in the specimen, then no color appears in the test line. Chicken IgY
conjugated with color particles are used as detectors for control line. The control line is used for
procedural control, and should always appear if the test procedure is performed properly and the test
reagents of the control line are working.
[MATERIALS PROVIDED]
1.Test strip and test tube
1×25 pieces
2.Extraction solution
6ml×2 bottles
3.Nasopharyngeal swab
1×25 pieces
4.Instructions for use
1 piece
5.Sponge base
1 piece
[MATERIALS REQUIRED BUT NOT PROVIDED]
Clock, timer or stopwatch
[STORAGE AND SHELF-LIFE]
Store kit at 4-30°C until expiration date. The shelf-life is 12 months temporarily.
Do not use frozen and expired devices.
Production date and expiry date please refer to packing label.
Test strip and test tube should be used immediately upon opening the pouch.
[SPECIMEN COLLECTION]
Only the nasopharyngeal swab provided in the kit is to be used for nasopharyngeal swab collection.
To collect a nasopharyngeal swab sample, carefully insert the swab into the nostril. Using gentle
rotation, push the swab until resistance is met at the level of the turbinates. Rotate the swab at least 5
times against the nasopharyngeal wall then slowly remove from the nostril.
[SPECIMEN TRANSPORT AND STORAGE]
Do not return the nasopharyngeal swab to the original paper packaging.
For best performance, direct nasopharyngeal swabs should be tested as soon as possible after collection.
If immediate testing is not possible, to maintain best performance and avoid possible contamination, it
is highly recommended the nasopharyngeal swab is placed in a clean, unused plastic tube labeled with
patient information, preserving sample integrity, and capped tightly at room temperature (18-26°C) for up
to 1 hour prior to testing. If greater than 1 hour delay occurs, the sample cannot be used.

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