SARS-CoV-2 Antigen Rapid Test

SARS-CoV-2 Overview
The new coronavirus belongs to the genus SARS-CoV-2 is an acute respiratory infectious disease. Individuals are generally susceptible. Currently, patients infected with the new coronavirus are the main source of infection; asymptomatic infected persons may also be an infectious source. According to current epidemiological investigations, the incubation period is 1 to 14 days, mainly 3 to 7 days. The main manifestations are fever, fatigue and dry cough. In some cases, nasal congestion, nasal discharge, sore throat, myalgia and diarrhea are observed. The antigen is usually detectable in upper respiratory tract specimens during the acute phase of infection. Rapid diagnosis of SARS-CoV-2 infection will help healthcare professionals to treat patients and manage 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 and no equiptment needed
★ High sensitivity and specificity
Contents
• 20 Test cassettes
• 20 Sterile swabs
• 20 sample extraction tube
• 2 Buffer
• 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.
Specifification
Information Time to result Storage Shelf life Specimen type
InDetail 15 minutes 4-30℃ 12 months nasopharyngeal swab or oropharyngeal swab
Performance Characteristics
SARS-CoV-2 Antigen Rapid Test Performance against with Comparator Method(nasopharyngeal swab/oropharyngeal swab)
SARS-CoV-2 Antigen Rapid Test Comparator Method Total
Positive Negative
Positive 95 1 96
Negative 5 399 404
Total 100 400 500
PPA: 95.00% (95%CI: 88.83%-97.85%)
NPA: 99.75% (95%CI: 98.60%-99.96% )
OPA: 98.80% (95%CI: 97.41%-99.45%)

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
CI: Confidence Interval

Test Procedure & Interpretation
Specimen collection

Use the nasopharyngeal swab or oropharyngeal swab supplied in the kit.

1.Nasopharyngeal swab collection method

01.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.
02.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.

2.Collection method of oropharyngeal swab

01.The head of the person to be collected is slightly tilted and his mouth is wide open, exposing the pharyngeal tonsils on both sides.
02.Wipe the swab across the root of the tongue. 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.

Sample preparation
Add 500μl (~20 drops) of sample extract to the 0.5 mark of the sampling tube, dip the swab after collecting the sample into the sample extract, make the sample extract fully permeate the swab, rotate and squeeze the swab 10 times, then pull out the swab, and take the stranded liquid as the sample to be tested.

Test procedure & interpretation of results

Ordering Information
Product Description Specimen Catalog No. Format Kit Size
SARS-CoV-2 Antigen Rapid Test nasopharyngeal swab or oropharyngeal swab H100G Cassette 20 Tests/Kit