Rapid Antigen Test Product Guides

Safecare Nasal Combo Guide

View our Nasal Combo Guide below or click here to download the PDF

SAFECARE COVID-19 & Influenza A+B Antigen Rapid Test

Package Insert for Self-Testing

INTENDED USE

Positive results are indicative only and must be confirmed by other clinical diagnostic results such as PCR, or RT-PCR. Negative results do not preclude Influenza and SARS-CoV-2 infection. Individuals who test negative and continue to experience Influenza or COVID-like symptoms should seek advice from a medical practitioner. Testing of individuals under the age of 16 should be performed by an adult/guardian.

SUMMARY

The novel coronaviruses belong to the β genus. COVID-19 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. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and Influenza can be similar and difficult to differentiate outside a laboratory setting.

Influenza is a highly contagious, acute, viral infection of the respiratory tract. The causative agents of the disease are immunologically diverse, single-strand RNA viruses known as influenza viruses. There are three types of influenza viruses: A, B, and C. Type A viruses are the most prevalent and are associated with most serious epidemics. Type B viruses produce a disease that is generally milder than that caused by type A. Type C viruses have never been associated with a large epidemic of human disease. Both type A and B viruses can circulate simultaneously, but usually one type is dominant during a given flu season. Influenza antigens may be detected in clinical specimens by immunoassay.

PRINCIPLE

SAFECARE COVID-19 & Influenza A+B Antigen Rapid Test is a lateral flow test for the simultaneous qualitative detection of SARS-CoV-2, Influenza A and B nucleocapsid protein antigens in self-collected nasal swab specimens. It is a membrane-based test device underpinned by immunoassay technology. The membrane contains active SARS-CoV-2, Influenza A and B specific antibodies that react with other reagents and antigens collected in a nasal swab specimen.

PROVIDED ITEMS

CONTENTS	1 Test /Kit	5 Tests /Kit	25 Tests /Kit
COVID-19 & Influenza A+B Antigen Rapid Test	1	5	25
Extraction tube with buffer	1	5	25
Sterilised nasal swab	1	5	25
Biohazard waste bag	1	5	25
Workstation	1	1	1
Package insert	1	1	1

ITEMS NOT PROVIDED

Timing device

WARNINGS AND PRECAUTIONS

Read instructions prior to performing test. Failure to follow the testing instructions may give inaccurate results.
This test is for in vitro diagnostic use only.
This test is intended for a single use only, do not reuse the test.
Do not use after expiration date.
Do not use if test kit is open or damaged.
Do not eat, drink, or smoke in the area where the specimens or kits are handled.
The provided nasal swab should be used only for nasal specimen collection.
Dispose of all specimens, reaction kits and potential contaminated material in the bag provided.
Test material should be used and discarded in accordance with local regulations.
Clean up spills thoroughly using an appropriate disinfectant.
Wash hands thoroughly before and after handling test components.
Don’t swallow the buffer. If buffer solution comes into contacts with the skin or eyes, flush with running water and seek medical attention.

INTERPRETATION OF RESULTS – FLU A+B

Positive Influenza A: Two distinct coloured lines appear in the left window. One coloured line should be in the control region (C) and another coloured line should be in the Influenza A region (A).
Positive Influenza B: Two distinct coloured lines appear in the left window. One coloured line should be in the control region (C) and another coloured line should be in the Influenza B region (B).
Positive Influenza A and Influenza B: Three distinct coloured lines appear in the left window. One coloured line should be in the control region (C) and two-coloured line should be in the Influenza A region (A) and Influenza B region (B).
Negative: One coloured line appears in the control region (C) of the left window. No apparent coloured line appears in the test line region (B/A).
Invalid: Control line fails to appear in the left window. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette.

INTERPRETATION OF RESULTS – COVID-19

Positive COVID-19: Two distinct coloured lines appear in the right window. One coloured line should be in the control region (C) and another coloured line should be in the Test region (T).
Negative COVID-19: One coloured line appears in the control region (C) of the right window. No apparent coloured line appears in the test line region (T).
Invalid: Control line fails to appear in the right window. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test Cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

*NOTE: The intensity of the colour in the test line region will vary depending on the concentration of the analyses in the specimen. Therefore, the intensity of the colour of any line in the test line region is irrelevant and should be considered.

BUILT-IN CONTROL

This test contains a built-in control feature, the C line on the test cassette. The C line develops after adding sample solution, if a C line does not appear then the test is invalid. Please review the test procedure and repeat instructions with a new device.

WHAT SHOULD I DO AFTER TEST?

If the test result is positive

Preliminary results suggest potential presence of a COVID-19 or Flu A or Flu B infection

Ø Contact your doctor / general practitioner or the local health department immediately

Ø Comply with local guidelines for self-isolation and confirmatory testing as necessary

If the test result is negative

Continue to comply with all applicable guidelines regarding contact with others and isolation

Ø An infection may also be present if the test is negative

Ø Repeat the test after 1 – 2 days, as the virus cannot be accurately detected in all phases of an infection

If the test result is invalid

Possibly caused by incorrect test execution

Ø Repeat the test with a new test device

Ø If the test results continue to return invalid results, contact a doctor or a COVID-19 test center

Note: Do not take any decision of medical relevance without first consulting your medical practitioner

PERFORMANCE CHARACTERISTICS

Clinical performance: A clinical evaluation was performed by comparing samples collected from the research reagent and nasopharyngeal samples collected from PCR testing. The test results for COVID-19 detection are summarised below:

	PCR Confirmed Samples	Identified Correctly	Rate
Positive Sample	110	95	86.4% (sensitivity)
Negative Sample	455	455	100.0% (specificity)
Total	565	550	97.3% (total accuracy)

Safecare Biotech (Hangzhou) Co., Ltd.

Building 2/203, No.18 Haishu Rd, Cangqian Sub-district

Yuhang District, Hangzhou, 311121, China

Email: admin@safecare.com.cn

Australia Sponsor & Distributor:

Maven Healthcare Pty Ltd

12/52 Holker Street

Silverwater NSW 2128 Australia

info@mavenhealthcare.com.au

www.mavenhealthcare.com.au

TEST LIMITATIONS

SAFECARE COVID-19 & Influenza A+B Antigen Rapid Test is intended for self-testing and may only be used for qualitative detection of SARS-CoV-2, Influenza A and B antigens. Results do not differentiate between SARS-CoV and SARS-CoV-2 viruses and is not intended to detect Influenza C antigens.
The colour intensity of a positive line shall not be evaluated as quantitative or semi-quantitative.
If testing is not performed within first 7 days of symptom onset, it is possible for this test to give a negative result that is incorrect (a false negative).
Product performance is evaluated using the procedures provided in this product insert only. Modifications to these procedures may alter test performance.
A negative result means that you are negative or that the viral load is too low to be recognised by the test.
A negative result does not rule out infection with SARS-CoV-2, Influenza A or B or any other type of respiratory virus.
A positive result is indicative only and requires confirmatory testing. It does not rule out co-infections with other pathogens.
False negative results may occur if a specimen is improperly collected, transported, or handled.
False negative test result may occur if the level of antigen in a sample is below the detection limit of the test.
Test results are less reliable in the later phase of infection and in asymptomatic individuals.
If you are symptomatic, you must seek immediate further testing by clinical or laboratory test i.e. PCR or, RT-PCR.
Reading the test results earlier than 10 minutes or later than 20 minutes may give incorrect results.
Contact the Therapeutic Goods Administration (TGA) if you wish to report poor performance or usability issues (Users Medical Device Incident Report, email iris@tga.gov.au or call 1800 809 361).

STORAGE AND STABILITY

Store unused test devices unopened at 4°C-30°C. If stored at 4°C-8°C, ensure that the test device is brought to room temperature before opening. The test device is stable through to the expiration date printed on the sealed pouch. Do not freeze test kit components under any circumstance.

TEST PROCEDURE

Please read all instructions carefully before you begin.

[Preparation before sampling]

Prepare a flat, dry area and disinfect thoroughly.
Wash your hands with soap and water for at least 20 seconds.
Open the test kit and check contents. Ensure all equipment specified are included prior to using.

[Specimen Preparation]

Peel off the foil film on the extraction tube and insert into the hole of workstation. (For 1 test/kit and 5 tests/kit, insert the extraction tube into the hole of the box.)
Open nasal swab package at the sticky end and take the nasal swab out.
Insert the soft tip of the nasal swab into left nostril until resistance is met (2.5cm or less).

Note: For child, the maximum depth of insertion into the nostril may be less than 2.5cm and should be appropriately adjusted by the person who collects sample.

Gently brush against the inside of the nostril in a circular motion rotating 5 times or more.
Move the nasal swab to the right nostril and repeat the previous action. Make sure an adequate sample is collected before removing from the nostril.
Insert the nasal swab into the tube which contains extraction buffer.
Rotate nasal swab at least 8-10 times while pressing nasal swab tip against the bottom and the sides of the tube.
Remove the nasal swab while squeezing the sides of the extraction tube to release as much liquid as possible.
Place the cap over the extraction tube and insert the tube back into the workstation or box. Place nasal swab into waste bag provided.

[Test Procedure]

1.Open the sealed pouch and take out the test cassette. For best results, the test should be performed as soon as possible.

Hold the tube vertically upside down over the sample well.
Add 3 drops specimen into each sample well by gently squeezing the sides of the tube, then start the timer.
Wait for coloured lines to appear and interpret against the instructions included.
The test result can be read in 10-15 minutes, DO NOT read after 20 minutes.

[After the testing]

After you have done the test, put remaining parts of the kit into the waste bag provided and seal it. Discard the waste bag in accordance with local regulations.
If you are doing more than 1 test, clean the table with 75% alcohol or sanitiser. Wash your hands between each test.

The clinical trial observed against COVID-19 detection demonstrated 86.4% sensitivity, 100% specificity and an overall accuracy of 97.3%. A CE marked reference kit was used to benchmark performance for the detection of Influenza A/B. The test results for Influenza A/B detection are summarised below:

	Reference Confirmed Samples	Identified Correctly	Rate
Positive Sample	42	42	100.0% (sensitivity)
Negative Sample	568	568	100.0% (specificity)
Total	610	610	100.0% (total accuracy)

The clinical trial observed against Influenza A/B detection demonstrated 86.4% sensitivity, 100% specificity and an overall accuracy of 97.3%

Limit of Detection: SAFECARE COVID-19 & Influenza A+B Antigen Rapid Test can detect out SARS and Influenza A/B virus strains as low as 1.3×10² TCID₅₀/mL and 4.32×10² TCID₅₀/mL respectively.
Cross-reactivity: Cross-reactivity studies are performed to demonstrate that the test does not react with the following microorganisms in the table below at concentration of 1×10⁵ TCID₅₀ /mL for viruses and 1×10⁵ CFU/mL for

Viruses:

Adenovirus, Rhinovirus, Enterovirus, MERS, Human metapneumovirus (hMPV), Human coronavirus OC43, Human coronavirus 229E, Human coronavirus NL63, Human coronavirus HKU1, Respiratory Syncytial Virus, Human parainfluenza virus 1, Human parainfluenza virus 2, Human parainfluenza virus 3, Human parainfluenza virus 4

Bacteria:

Bordetella pertussis, Chlamydia pneumoniae, Haemophilus influenzae, Legionella pnuemophila, Mycoplasma pneumoniae, Streptococcus pneumoniae, Streptococcus pyogenes, Mycobacterium tuberculosis, Staphylococcus aureus, Candida albicans

Interfering Substances: The following endogenous interference substances were evaluated at the concentrations listed and no effect was found.

Whole blood (2%), three OTC nasal sprays (10%), three OTC nasal drop (25%), three nasal mouthwashes (25%), 4-Acetamidophenol (10mg/mL), Acetylsalicylic acid (20mg/mL), Chlorpheniramine (5 mg/mL), Dextromethorphan (10mg/mL), Diphenhydramine (5mg/mL), Ephedrine (20mg/mL), Guaiacol glyceryl ether (20mg/mL), Oxymetazoline (10mg/mL), Phenylephrine (100mg/ml), Phenylpropanolamine (20mg/mL) ,Oseltamivir Phosphate (10mg/mL), Mupirocin (10mg/mL),Vitamin A (10%), D-Panthenol (10%)