COVID-19 Disposable Antigen Test Kit ISO CE Colloidal Gold Medical Use

Immunochromatographic Assay (GICA) technology which is
intended for the in vitro qualitative detection of the SARS-CoV-2
virus antigen nucleocapsid (N) protein in human nasal swab,
nasopharyngeal swab, oropharyngeal swab samples.
SARS-CoV-2 with envelope and round or oval particles is a new
type of coronavirus within the genus of betacoronaviruses.
Respiratory droplet transmission and contact transmission are the
main transmission routes. The population is generally susceptible,
the incubation period is generally 3 to 7 days, a few cases exceed
14 days, and there is infectiousness during the incubation period.
Nucleocapsid protein (NP) is an important conserved structural
protein of SARS-CoV-2. It plays a key role in the process of virus
assembly, replication and protein translation. It can usually be
detected in upper respiratory tract specimens in the acute phase of
infection. This kit can be used for the clinical diagnosis of patients
with the novel coronavirus infection. A negative result needs to be
supplemented by PCR testing and is not the only criterion for
clinical diagnosis.
【Test Principle】
This kit uses Colloidal Gold Immunochromatographic Assay
(GICA) technology, which is composed of mouse anti-SARS-CoV-2
NP antibody nitrocellulose membrane and NP antibody labeled the
gold labeling pad and other reagents. During detection, if
SARS-CoV-2 is present in the sample, after the sample is processed,
will specifically bind to the SARS-CoV-2 NP to form a complex.
This complex moves forward along the test strip due to the
chromatographic effect and is captured by the mouse anti-NP
antibody in the testing line.
where forms a sandwich complex and agglomerates to develop
color.
If it is a negative specimen, it cannot form a complex and
cannot be captured by a specific antibody in the detection area, so
it does not develop color. Regardless of whether there is
SARS-CoV-2 in the sample, a colored bar will appear at the
quality control line (C) as an internal control standard for whether
the chromatography process is normal and whether the reagent is
invalid.
【Main Components】
1.Test strips individually foil pouched with a desiccant
2.Sample Processing Solution (SPS), 1 bottle.
3.Disposable Extraction tubes .
4.Disposable Extraction tube cap.
5.Sample Collecting Swab
Note: Components in different batches of reagent kits are not
interchangeable, otherwise there will be mistakes.
【Storage Conditions & Shelf Life】
1.The kit should be stored at 2~30°C and keep away from light.
The validity period is 18 months.
2.If the test card is unused, it must be immediately put back into
the packaging bag with desiccant and sealed for storage.
3.Production date and expiration date are shown on the label.
【Sample Requirements】
1.This kit is limited to the detection of human nasal swabs,
nasopharyngeal swabs, oropharyngeal swabs, etc.
2.Collection requirements:
Nasal Swab: Carefully insert the swab into one nostril of the
patient. The swab tip should be inserted up to 2-4 cm until
resistance is met. Roll the swab 5 times along the mucosa inside
the nostril to ensure that
both mucus and cells are
collected. Using the same
swab, repeat this process
for the other nostril to
ensure that an adequate
sample is collected from
both nasal cavities.
Withdraw the swab from
the nasal cavity.
Nasopharyngeal swab:
The subject cleans the nasal
cavity in advance. After
gently insert the
nasopharyngeal swab
through the subject’s
nostrils, it goes deep
perpendicular to the surface
of the head or face, from
the lower nasal passage to
the posterior wall of the
nasopharynx. The nasopharyngeal swab should be twisted on
the nasopharyngeal mucosa, and kept for 10-15 seconds, and
then take it out.
Oropharyngeal swab: The
subject cleans the nasal
cavity/oral cavity in
advance. Use a tongue
depressor (spatula) to
depress the tongue. The
swab crosses over the
subject’s tongue to the
posterior wall of
pharyngeal and the crypts
and sidewalls of tonsil etc.
Repeatedly wipe 3 to 5 times to collect mucosal cells.
3.Open the disposable extraction tube, place the swab in the
extraction tube. The head of the swab should be completely
immersed in the extraction tube. Stir 3~5 times for 1 minute.
Take out the swab and tighten the extraction tube cover.
4.The sample can be stored at room temperature for 8 hours. If
it’s not available for testing immediately, it can be stored at
2~8 ℃ for 7 days. Samples over 7 days are not applicable.