TouchBio RSV, ADV, FLU A/B & COVID-19 Rapid Antigen Combo Test

For Self-Testing

Model: K881416D

Product Overview

A rapid test for the qualitative detection of novel coronavirus antigens, influenza A&B virus, respiratory syncytial virus (RSV), and adenovirus (ADV) in nasal swabs. For self-testing use.

Components Provided

Test Cassette (Device)
Sterilised Swab
Extraction Buffer Tube with Lid Seal
Instructions For Use
Dropper Lid
Biohazard Specimen Bag

Component required but not provided: TIMER ⏱️

How to Perform the Test

Preparation

Step 1: Wash or clean your hands ? and make sure they are dry before starting the test.
Step 2: Read the instructions for use ? carefully.
Step 3: Take out one extraction tube, pull off the sealed aluminum foil on the extraction tube. Place the extraction tube into a tube stand or box.
Step 4: Unpack the sterile swab. ?
Step 5: Tilt your head back slightly.
Step 6: Insert the swab about 2 cm (at least with the entire soft swab tip) into the left nostril ?. Gently rotate the swab at least five times ? against the nasal wall.
Step 7: Insert the same swab about 2 cm (at least with the entire soft swab tip) into the right nostril ?. Again, gently rotate the swab at least five times ? against the nasal wall.
Step 8: Remove the swab from the second nostril. Discard the swab in the biohazard specimen bag ☣️.
Step 9: Screw on and tighten the nozzle onto the extraction tube. CLOSE ?.
Step 10: Gently shake the tube by inverting it or flicking the base for 30 seconds to mix the specimen with the extraction buffer, avoiding foam or bubbles.
Step 11: Open the foil pouch and take out the test cassette ?. Place the test cassette on a flat, clean surface.
Step 12: Add 3 drops ? of the solution from the specimen collection tube to each sample well (S) of the test cassette.
Step 13: Set the timer for 15 minutes ⏱️. IMPORTANT: Do not read the result before 15 minutes, even if a line has appeared at the control region (C). The test results will be invalid if read after 20 minutes.
Step 14: Please dispose of the test materials in a biohazard specimen bag ☣️ with household refuse, following any local regulations.
Step 15: Wash your hands thoroughly ? after test completion.

CAUTION: Do not touch swab tip when handling the swab. Perform the test within 60 minutes ⏳ after opening the foil pouch.

Interpretation of the Results

Note: The shade of color may vary, but it should be considered positive whenever there is even a faint line.

Positive Results

POSITIVE SARS-Cov-2: Two red lines appear. One red line in the control region (C) and one red line in the test region (Cov).
POSITIVE Influenza A: Two distinct colored lines appear. One line in the control region (C) and another line in the Influenza A region (A).
POSITIVE Influenza B: Two distinct colored lines appear. One line in the control region (C) and another line in the Influenza B region (B).
POSITIVE Influenza A and Influenza B: Three distinct colored lines appear. One line in the control region (C), one line in the Influenza A region (A), and one line in the Influenza B region (B).
POSITIVE RSV: Two red lines appear. One red line in the control region (C) and one red line in the test region (Rsv).
POSITIVE ADV: Two distinct red lines appear. One red line in the control region (C) and another red line in the test region (Adv).

Weakly Positive

A faint line in the test region indicates a positive result.

Negative Result

NEGATIVE: Only one red line appears in the control region (C), and no line in any test region (B/A/Cov/Adv/Rsv). If symptoms persist, seek professional medical advice and consider repeat testing.

Invalid Result

INVALID: No red line appears in the control region (C). The test is invalid even if there is a line in a test region. Insufficient sample volume or incorrect procedural techniques are common reasons for control line failure. Review the test procedure and repeat the test using a new device. If the problem persists, discontinue use and contact your local distributor.

What to do if you test positive?

If you have a POSITIVE result, stay home to protect others. Avoid high-risk settings like hospitals and aged care facilities. If you feel unwell or need advice, consult your health provider or call a health helpline (e.g., Healthdirect Australia: 1800 022 222). If you develop severe symptoms like shortness of breath or chest pain, call emergency services immediately (e.g., triple zero (000) in Australia).

Intended Use

The TouchBio RSV, ADV, FLU A/B & COVID-19 Rapid Antigen Combo Test (Nasal) is an in-vitro immunochromatographic assay for the qualitative detection of SARS-CoV-2 nucleoprotein antigen, influenza A/B nucleoprotein antigen, RSV F antigen, and ADV hexon protein in nasal swabs. It is used as an aid for diagnosis of COVID-19 (within 7 days of symptom onset), Influenza A/B (within 4 days of symptom onset), RSV (within 6 days of symptom onset), and ADV (within 6 days of symptom onset). This kit is intended for layperson's home use in a non-laboratory environment. It is not intended for children under three years old.

Principle of the Test

The TouchBio RSV, ADV, Flu A/B & COVID-19 Rapid Antigen Combo Test is a lateral flow immunoassay based on the double antibody sandwich technique. Monoclonal antibodies conjugated with colored microparticles act as detectors. During the test, antigens in the sample interact with these labeled antibodies, forming a complex that migrates along the membrane. If antigens are present, they are captured by pre-coated antibodies at the test lines (Cov, A, B, Rsv, Adv), resulting in a visible colored line. The control line (C) appears if the test procedure is performed correctly.

Limitations

False positive results may occur, especially in individuals without symptoms or in areas with low infection rates.
A negative test result does not exclude infection, as antigen concentration may be below the detection limit or the sample may have been collected/transported improperly.
The test detects antigens from viable and non-viable viruses. Performance depends on antigen load and may not correlate with cell culture.
Positive results do not rule out co-infections with other pathogens. Results should be interpreted alongside other clinical and laboratory information.
Performance for monitoring antiviral treatment is not established.
Negative results for COVID-19 do not rule out infection with other coronaviruses.
Negative results for any virus do not rule out infection with other respiratory viruses.
Repeat testing is recommended if infection is suspected, especially in high-risk settings or occupations.
Risk of false-negative results is higher if testing is not performed within the recommended symptom onset windows (7 days for COVID-19, 4 days for Influenza A/B).
Tests are less reliable in later stages of infection and in asymptomatic individuals.
A positive result does not necessarily confirm infectiousness.
SARS-coronavirus may affect test results for COVID-19 but not for Flu A/B, RSV, or Adv.

Storage and Stability

Store the test cassette at room temperature or refrigerated (2-30°C). Do not freeze. ?❄️
Reagents are stable until the expiration dates marked on the packaging.
Test the sample within one hour after opening the foil pouch, with relative humidity (RH) less than 80%.

Performance Characteristics

Clinical Evaluation

Comparison with RT-PCR kits showed the following sensitivities and specificities:

Virus	Sensitivity	Specificity
COVID-19	95.45%	>99.9%
Flu A	97.80%	>99.9%
Flu B	97.50%	>99.9%
RSV	93.55%	>99.9%
ADV	98.33%	>99.9%

Usability Study

Comparison with RT-PCR kits for layperson use showed:

Virus	Sensitivity	Specificity
COVID-19	97.22%	>99.99%
Flu A	96.77%	>99.99%
Flu B	96.97%	>99.99%
RSV	96.77%	>99.99%
ADV	>99.99%	>99.99%

Variants Information

Detected SARS-CoV-2 variants: P1, Delta, Omicron.

Detected Influenza strains include: A/Darwin/6/2021, A/Darwin/9/2021, A/Victoria/2570/2019, Hong Kong/2671/2019, A/Guangdong-Maonan/SWL 1536/2019, A/Brisbane/02/2018, A/Michigan/45/2015, A/Victoria/361/2011, A/Texas/50/2012, A/California/7/2009, A/SouthAustralia/34/2019, A/Switzerland/8060/2017, A/Singapore/lNFIMH-16-0019/2016, A/Sydney/5/2021, B/Phuket/3073/2013 (B/Yamagata lineage), B/Austria/1359417/2021 (B/Victoria lineage), B/Washington/02/2019 (B/Victoria lineage), B/Colorado/06/2017 (B/Victoria/2/87 lineage), B/Massachusetts/2/2012.

Detected RSV strains: A-2, Long, 9320, Washington, B-1 wild type.

Detected ADV strains: Type 1, Type 2, Type 3, Type 4, Type 5, Type 6, Type 7, Type 8, Type 11, Type 18, Type 23, and Type 55.

Limit of Detection (LoD)

LoD values: Covid-19: 6.25x10² TCID50/mL; Flu A (H1N1): 1.0x10² TCID50/mL; Flu B (B-Victoria Lineage): 1.0x10³ TCID50/mL; RSV (A-2): 2.4x10² TCID50/mL; Adv (Ad3): 1.8x10² TCID50/mL.

Cross Reaction

SARS-coronavirus affects COVID-19 test results. No cross-reactivity observed with other tested microorganisms and analytes, including MERS-coronavirus, Legionella pneumophila, Mycobacterium tuberculosis, Streptococcus pneumoniae, Streptococcus pyogenes, Mycoplasma pneumoniae, other Coronaviruses (229E, OC43, NL63, HKU1), Human Metapneumovirus, Parainfluenza virus, Rhinovirus A16, Candida albicans, Pseudomonas aeruginosa, Staphylococcus epidermis, Staphylococcus salivarius, Enteroviruses, Chlamydia pneumoniae, Haemophilus influenzae, Bordetella pertussis, and Pneumocystis jirovecii. The kit can detect co-infections.

Interfering Substances

No interference was observed with substances including Mucin, Whole Blood, Biotin, Phenylephrine, Oxymetazoline, Saline Nasal Spray, Zicam Allergy Relief Nasal Gel, Sodium Cromoglycate, Olopatadine Hydrochloride, Zanamivir, Oseltamivir, Artemetherlumefantrine, Doxycycline hyclate, Quinine, Lamivudine, Ribavirin, Daclatasvir, Acetaminophen, Staphylococcus aureus, Acetylsalicylic acid, Ibuprofen, Mupirocin, Tobramycin, Erythromycin, Ciprofloxacin, Ceftriaxone, Meropenem, Histamine Hydrochloride, Peramivir, Flunisolide, Budesonide, Fluticasone, Lopinavir, Ritonavir, Abidor, pooled human nasal wash, and HAMA.

Safety and Information

Precautions

For in-vitro diagnostic use only. ?
Ensure the foil pouch is not damaged before use.
Perform the test at room temperature (15 to 30°C). ?️
Do not substitute kit components with those from other kits.
Strictly follow operating instructions.
Test samples immediately after collection.
Children aged 3 to 15 years old should have samples collected and tested by an adult.
Do not use the test for anyone under 3 years old. ?
The test is for single use only.
Dispose of used test materials in a medical waste bin.
Test kit solutions should only be used as directed; do not ingest.
Avoid contact of buffer with skin ✋ and eyes ?️. If contact occurs, flush with plenty of water ?. Seek medical advice if irritation persists.
Keep buffer out of reach of children ? and pets ?.

Contact and Distributor Information

Australian Distributor

Touch Biotechnology Pty Ltd

Customer Support Number: 1300 166 282

Hours: 9am-7pm (AEST), or 9am-8pm (AEDT), 7 days per week

Website: www.touchaustralia.com.au

Email: touch@touchaustralia.com.au

Address: 119 Willoughby Road, Crows Nest, NSW 2065

Australia Sponsor

Sonictec Pty Ltd

Address: U211/17 Chisholm St, Wolli Creek NSW 2205

Hours: 9am - 7pm (AEST), or 9am - 8pm (AEDT), Monday - Friday

Web: www.sonictec.com.au

Email: info@sonictec.com.au

Manufacturer

Address: #2 Building, No. 763, Yuansha Village, Xinjie Street, Xiaoshan District, 311200 Hangzhou City, Zhejiang Province, PEOPLE'S REPUBLIC OF CHINA

Website: www.realytech.com

Medical Device Incident Report

Report performance or usability issues to the Therapeutic Goods Administration (TGA) via their online Users Medical Device incident Report, email iris@health.gov.au, or call 1800 809 361.

Symbols Used

The document displays various symbols, including those for: In-vitro diagnostic use (?), Caution (⚠️), Do not freeze (?❄️), Temperature range (?️), Biohazard (☣️), Wash hands (?), Read instructions (?), Timer (⏱️), Nostril (?), Rotate (?), Squeeze (?), Discard (?️), Test cassette (?), Add drops (?), Skin contact (✋), Eye contact (?️), Flush with water (?), Children (?), Pets (?), Close (?), and general positive (✅), negative (❌), invalid (❓) result indicators.