COVID-19 Test KitsCOVID-19 Test Kits

COVID-19 RAPID ANTIGEN SELF-TESTING KITS

RightSign rapid test for the qualitative detection of COVID-19 antigen in Nasal Swab in symptomatic individuals. The COVID-19 Antigen Rapid Test Cassette
(Nasal Swab) is a rapid chromatographic immunoassay for the qualitative detection of COVID-19 antigen in Nasal Swab. The results are used to identify the
SARS CoV-2 antigen test within the first 7 days of symptom onset when viral shedding/viral load is at its highest. Individuals who test positive should
confirm the results with a laboratory PCR test, self-isolate and notify their healthcare provider.

This product is currently not permitted to be sold in South Australia or Western Australia.

QUICK REFERENCE GUIDE

Quick Reference GuideQuick Reference Guide

INSTRUCTIONS FOR USE

Instructions For UseInstructions For Use

FREQUENTLY ASKED QUESTIONS

How accurate is the test?

A clinical evaluation was conducted comparing the results obtained using the COVID-19 Antigen Rapid Test Cassette (Nasal Swab) to PCR. Specimens were considered positive if PCR indicated a positive result.

For 103 cases of PCR positive, the Relative Sensitivity the COVID-19 Antigen Rapid Test Cassette (Nasal Swab) is 93.2% (96/103).

For 250 cases of PCR negative, the Relative Specificity of COVID-19 Antigen Rapid Test Cassette (Nasal Swab) is 99.2% (248/250).

For 103 cases of PCR positive and 250 cases of PCR negative, the Relative Accuracy of COVID-19 Antigen Rapid Test Cassette (Nasal Swab) is 97.5% (344/353).

A usability study was performed by lay person, 150 subjected were enrolled and self-tested with package insert and quick reference guide only, relative sensitivity was 93.75% (30/32), relative specificity was 99.12% (112/113). The results showed that the labeling provided with the test kit was comprehensive for its intended population, the ease of use was suitable for its intended population.

Detection Limit: The detection limit for the COVID-19 Antigen Rapid Test Cassette (Nasal Swab) is 1000 TCID50 /mL.

Will other diseases affect the result?

No cross reactivity has been observed on testing by following commonly found respiratory/ oropharyngeal pathogens:

Influenza A virus, Influenza B virus, Adenovirus, Coxsackie virus, Parainfluenza Virus Type1, Parainfluenza Virus Type2, Parainfluenza Virus Type3, Parainfluenza Virus Type4a, Enterovirus, Mumps virus, Respiratory syncytial virus, Rhinovirus, Bordetella pertussis, Haemophilus parainfluenzae, Staphylococcus aureus, Streptococcus agalactiae, Neisseria meningitides, Streptococcus sp. group A, Streptococcus sp. group B, Streptococcus sp. group C, Candida albicans, Human Metapneumovirus (hMPV), Legionella pneumophila, Mycobacterium tuberculosis, Mycoplasma pneumoniae, Pneumocystis jirovecii(PJP)-S cerevisiae Recombinant, Pseudomonas aeruginosa, Staphylococcus epidermis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus salivarius, Human coronavirus 229E, Human coronavirus OC43, Human coronavirus NL63 and MERS-coronavirus positive specimens.

However, a false result due to presence of these organisms at a level higher than tested cannot be ruled out.

Will this test hurt?

No, the nasal swab is not sharp and it should not hurt. Sometimes the swab can feel slightly uncomfortable or tickly. If you feel pain, please stop the test and seek advice from a healthcare provider.

I have a nosebleed after swabbing my nose. What should I do?

In the unlikely event your nose starts bleeding, apply pressure to your nose until the bleeding stops and consult a healthcare professional. Do not insert the Swab again.

How do I know that the test was run properly?

A procedural control is included in the test. A colored line appearing in the control line region (C) is considered an internal procedural control. It confirms adequate membrane wicking.

What should I do if the result shows positive?

You must take a laboratory PCR test immediately, self-isolate and contact your local health authority or the National Coronavirus Helpline on 1800 020 080 for further advice. You should also inform the immediate contacts you have had in past 24 hours so they can take any appropriate precautions.

What should I do if the result shows negative?

Negative results may require additional testing to confirm your results if you are symptomatic. If symptomatic, continue antigen testing every 24 hours for 3 days or take a laboratory PCR test. If asymptomatic, it is likely that you were not infectious at the time the test was taken. A negative test result, however, is not a guarantee that you do not have coronavirus. Please continue to follow social distancing, washing hands regularly and wearing masks as directed.

Can RightSign COVID-19 Antigen Test detect various variants of COVID-19?

Yes, RightSign COVID-19 Antigen Test can detect Alpha, Beta, Gamma and Delta COVID-19 mutants based on the studies conducted so far.

Can any substances interfere with the RightSign COVID-19 Antigen Test

The COVID-19 Antigen Rapid Test Cassette has been tested for Ambroxol Hydrochloride Tablets (7.5 mg/mL), Nasal antibioitic (Mupirocin Ointment), Mometasone furoate nasal spray (0.05% g/g), Oxymetazoline Hydrochloride Spray, Nin Jiom Pei Pa Kao cough syrup, Beclomethasone Dipropionate Nasal Aerosol, Dextromethorphan Hydrobromide Oral Solution(1.5 mg/ml), Triamcinolone Acetonide Nasal Spray, MucosolvanAmbroxol Hydrochloride Oral Solution, Azelastine Hydrochloride Nasal Spray, Nasal cleansing solution, NaCl (5 g/L), Fluticasone Propionate Nasal Spray, Hyland's 4 Kids Cold Cough Liquid Safe Natural Relief, Physiological Seawater Nasal Spray, Durham's Canker-Rid, Tobramycin Eye Drops, Listerine mouthwash ,Whole blood (4%), Scope mouthwash, Mucin (0.05%). No substances above showed any interference with the test.

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