COVID-19 Antigen Rapid Test Kit
SKU: PDRTKTA-U
Overview
The novel corona viruses belong to the β genus. SARSCoV-2 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel corona virus 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 diarrhoea 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 and no equipment needed
- High sensitivity and specificity
Kit contents
- Test cassette
- Sterile swab
- Extraction tube
- Antigen extraction buffer
Organisations and businesses who already are or wish to implement a test tracking program, please click on the link below to download the Panodyne COVID-19 Antigen Test declaration form for subjects to sign and for your records. The declaration form can be used for research and consent form purposes only.
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
- Time to result: 15 minutes
- Storage: 2-30˚C
- Shelf life: 24 months
- Specimen type: 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 Test | Positive | Negative | Total |
Positive | 206 | 3 | 209 |
Negative | 3 | 306 | 309 |
Total | 209 | 309 | 518 |
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 / Tota
Nasopharyngeal swab collection method:
- The operator holds the swab by the right hand and holds the head of the person firmly with the left hand. Insert the swab down towards the bottom of the nasal cavity and penetrate slowly and gently. Do not overexert to avoid traumatic haemorrhage.
- Swab should reach depth equal to distance from nostrils to outer opening of the ear. Gently rub and roll the swab. Leave swab in place for several seconds to absorb secretions. Slowly remove swab while rotating it.
Oropharyngeal swab collection method:
- The head of the person should be slightly tilted and their mouth 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 three times, and then wipe up and down the posterior pharyngeal wall for at least three times. Avoid touching teeth and gums.
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.
Interpretation of results
Add 2-3 drops to the sample well and wait 15 minutes for the results.
Since its establishment in August 2020, the joint UK Health Security Agency (UKHSA) Porton Down and University of Oxford SARS-CoV-2 lateral flow antigen test validation cell has evaluated over 160 lateral flow devices that have been referred by the Department of Health and Social Care.
Read further information about Panodyne COVID-19 ANTIGEN RAPID TEST KIT passing phase 3 validation:
