Categories | Rapid Test Kits |
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Brand Name: | HUACHENYANG |
Certification: | ISO13485,NMPA, |
Place of Origin: | Guangdong, China |
Safety standard: | None |
Packing: | Carton or according to customer's need |
Material: | Nylon Head, ABS Stick |
Application: | Antigen Rapid Test Kit |
OEM: | Support OEM |
25 Pack Antigen Rapid Test Kits Oropharyngeal Nasopharyngeal Swab Test
COVID-19 Antigen Rapid Test Kit (25-Pack): Oropharyngeal/Nasopharyngeal Swab Test
product description:
The COVID-19 Antigen Detection Kit (Transverse Chromatography) is
an immunochromatographic method for the rapid, qualitative
detection of SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab
samples, either directly or after swab collection. 2 nucleocapsid
protein antigens. Added to viral transmission media by individuals
suspected of having COVID-19 by a healthcare provider, testing is
limited to accredited laboratories that meet requirements to
perform moderate, high, or exempt complexity testing. The test is
authorized for use at the point of care (POC), which is an
inpatient care setting operating on the basis of a certificate of
exemption, certificate of compliance, or certificate of
accreditation. This test is used to identify SARS-CoV-2
nucleocapsid antigens that are commonly detected in upper
respiratory tract samples during the acute phase of infection. A
positive result indicates the presence of viral antigens, but
clinical correlation with the patient's medical history and other
diagnostic information is necessary to determine infection status,
and a positive result does not rule out bacterial infection or
co-infection with other viruses.
Notice:
Negative results should be considered presumptive, do not exclude
SARS-CoV-2 infection, and should not be used as the sole basis for
treatment or patient management decisions, including infection
control decisions. Negative results should be considered in
conjunction with the patient's recent exposure, medical history,
and the presence of clinical signs and symptoms consistent with
COVID-19, and confirmed by molecular analysis, if necessary, for
patient management.
Safety standard | None |
Packing | Carton or according to customer's need |
Material | Nylon Head, ABS Stick |
Application | Antigen Rapid Test Kit |
OEM | Sampling swab |
Support OEM | Place of Origin |
Product Usage:
This assay is used for the direct and qualitative detection of
SARS-CoV-2 antigens in nasopharyngeal and oropharyngeal secretion
specimens. Provides clinical results in 15 to 30 minutes, and
visual interpretation of results requires no special equipment.
Product Description:
The COVID-19 Antigen Detection Kit (Lateral Chromatography) is
intended for use by trained clinical laboratory personnel who have
been specifically instructed and trained in in vitro diagnostic
procedures and appropriate infection control procedure techniques,
as well as in point-of-care settings Individuals with similar
training.
Product Instructions:
Sample collection and preparation:
1. Set up the test
2. Remove one extraction tube and one COVID-19 Antigen Detection
Kit (Transverse Chromatography) cartridge from the foil bag
immediately before testing.
3. Label the test kit and extraction tube for each sample to be
tested. Place the labeled extraction tubes on the rack in the
designated area of the work area.
Nasal swab specimen collection:
When taking a nasal swab sample, carefully insert the swab
(attached in the kit) into the nostril where the most secretions
are visually observed. Gently rotate and push the swab to the point
of resistance of the turbinate (approximately 2.0-2.5 cm or 1 inch
near the nostril), then roll the swab about five times over the
nasal wall and remove.
Sample Preparation:
Immediately after specimen collection, immerse the swab in sample
extraction buffer.
For complete extraction of the sample, from the swab into the
buffer, rotate the swab against the tube wall repeatedly for 10
seconds, then hold the tube (the tube wall is semi-solid) with your
fingers and squeeze the swab several times while Slowly remove the
swab from the tube. The purpose of the swab against the tube wall
is important, as it keeps the liquid-containing specimen in the
tube as much as possible. After removing the swab and discarding it
into the biohazard waste container, place the nozzle (provided in
the kit) tightly on top of the extraction tube and gently shake the
tube to thoroughly mix the liquid inside.
Interpretation of results:
Positive Test Result: Visible color lines appear at both the "T"
and "C" sites, or a darker color if the "T" site is tested.
Negative test result: Only the "C" reference is colored, the "T"
position is blank.
Invalid result: If "C" is empty and no color is displayed, the test
result is invalid and the sample needs to be re-tested.
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