Description
The novel coronaviruses belong to the \u001f genus. SARS-CoV-2
is an acute respiratory infectious disease. People are generally
susceptible. Currently, the patients infected by the novel coronavirus are
the main source of infection; asymptomatic infected people can also be
an infectious source. Based on the current epidemiological investigation,
the incubation period is 1 to 14 days, mostly 3 to 7 days. The main
manifestations include fever, fatigue and dry cough. Nasal congestion,
runny nose, sore throat, myalgia and diarrhea are found in a few cases.
Antigen is generally detectable in upper respiratory specimens during the
acute phase of infection. Rapid diagnosis of SARS-CoV-2 infection will
help healthcare professionals to treat patients and control the disease
more efficiently and effectively.
Benefits
Rapid testing for SARS-CoV-2 antigen within 15 minutes
Facilitates patient treatment decisions quickly
Simple, time-saving procedure
All necessary reagents provided & no equipment needed. High
sensitivity and specifificity
Contents
• 1 Test cassette
• 1 Sterile swab
• 1 Sample extraction tube
• 1 Dropper tip
• 1 Package insert
Intended Use
The SARS-CoV-2 Antigen Rapid Test is
intended for in vitro qualitative detection
to SARS-CoV-2 antigen in human
nasopharyngeal swab or oropharyngeal
swab samples.
Specification
Performance Characteristics
SARS-CoV-2 Antigen Rapid Test Performance with Comparator Method
(nasopharyngeal swab/oropharyngeal swab)
Information Time to result Storage Shelf life Specimen type
In detail 15 minutes 2-30°C 24 months Nasopharyngeal swab or
oropharyngeal swab
PPA: 90.91% (95%CI: 76.43%-96.86%)
NPA: 99.02% (95%CI: 94.66%-99.83%)
OPA: 97.04% (95%CI: 92.63%-98.84%)
EXPLANATION OF TERMS:
PPA: Positive Percent Agreement = True Positives / True Positives + False Negatives
NPA: Negative Percent Agreement = True Negatives / True Negatives + False Positives.
OPA: Overall Percent Agreement = True Positives + True Negatives / Total
SARS-CoV-2
Test Procedure & Interpretation
Specimen collection
Use the nasopharyngeal swab or oropharyngeal swab supplied in the kit.
For 3
seconds
Double
nostril
sampling
1. Nasopharyngeal swab collection method:
2. Collection method of oropharyngeal swab:
The operator holds the swab by
the right hand and holds the
head of the subject fixedly by left
hand. Putting the swab downing
backwards the bottom of the
nasal cavity and penetrate slowly
and gently. Do not overexert to
avoid traumatic hemorrhage.
When the cusp of the swab touching the paries
posterior of the pharyngonasal cavity, letting the
swab remain in the place for a few seconds
(about 3 seconds) and rotating the swab gently
for one cycle, and then remove the swab slowly.
The head of the person to be
collected is slightly tilted and his
mouth is wide open, exposing
the pharyngeal tonsils on both
sides.
Wipe the pharyngeal tonsils on both sides of
the person to be collected back and forth with a
little force for at least 3 times, and then wipe up
and down the posterior pharyngeal wall for at
least 3 times.
Both sides of the
pharyngeal tonsils at
least 3 times, up
and down the
posterior pharyngeal
wall at least 3 times
1. 2.
1. 2.
Specifications
Brand
Own Brand