touch BIO VMD71 RSV FLU A-B and Covid-19 Rapid Antigen Combo Test Instruction Manual

October 30, 2023
touch BIO

touch BIO VMD71 RSV FLU A-B and Covid-19 Rapid Antigen Combo Test

touch-BIO-VMD71-RSV-FLU-A-B-and-Covid-19-Rapid-Antigen-Combo-
Test

TouchBio RSV, FLU A/B & Covid-19 Rapid Antigen Combo Test (Nasal)

TouchBio RSV, FLU A/B & Covid-19 Rapid Antigen Combo Test (Nasal) is an Antigen Rapid Test used to detect SARS-CoV-2, Flu A/B, and RSV in nasal swab. This test is for self-testing use and is manufactured by Touch Biotechnology Pty Ltd.

Test Procedure
Read the instructions carefully before taking the test.

Step 1: Wash your hands
Wash or clean your hands and make sure they are dry before starting the test. After washing your hands, open the box and check the components before use.

Step 2: Read Instructions for Use
Read instructions for use carefully before using the test.

Step 3: Place the buffer tube into the holder
Carefully place extraction tube into tube holder or tube stand. Open the lid. Watch How to Use Video Scan the QR code for information on how to use the test.

IMPORTANT: Do not drink the extraction buffer liquid. If you accidentally drink it, immediately consult your healthcare professionals. Do not spill any of the extraction buffer liquid. If you spill it, sterilize the area, and repeat the test by using a new sampling swab and extraction solution tube.

Step 4: Take the sterilized swab
Pull open the swab packaging at the marked point and remove the swab. Do not touch soft head of swab. Do not open the swab until you are going to use it immediately.

Step 5: Sample Collection
Tilt your head back slightly. Gently insert the swab about 2cm into the left nostril. At least with the entire soft swab. Gently rotate the swab at least 5 times against the nasal wall. Do the same for the right nostril Gently insert the swab about 2cm. At least with the entire soft swab. Gently rotate the swab at least 5 times against the nasal wall. Remove the swab from the second nostril.

IMPORTANT: If the swab stick breaks during the sample collection, please use a new swab. Do not insert the swab deeper if you feel strong resistance or pain.

Step 6: Insert the swab
Insert the sampled swab into the extraction buffer tube, and dip the tip into the tube. Rotate the swab tip 10 times along the inner wall of the buffer tube. And squeeze the tip of the swab 5 times along the inner wall of the tube to keep as much liquid in the bottle as possible.

Step 7: Take out the swab
Remove the swab from the tube by squeezing the sides of the tube to release the liquid from the swab.

IMPORTANT: If squeezing of tube is not done correctly, sample swab absorbs much more liquid form the extraction buffer and that will yield wrong results.

TEST PROCEDURE

TouchBio RSV, FLU A/B & Covid-19 Rapid Antigen

Combo Test (Nasal)

REF: VMD71

An Antigen Rapid Test for the detection of SARS-CoV-2, Flu A/B and RSV in nasal swab. For Self-Testing use.

Read the instructions carefully before taking the test.
IMPORTANT
Australia Sponsor & Distributor
Touch Biotechnology Pty Ltd

STEP-1 Wash your hands
Wash or clean your hands and make sure they are dry before starting the test.

After washing your hands, open the box, and check the components before use.

STEP-2 Read Instructions for use
Read instructions for use carefully before using the test.

Customer Support Number: 1300 166 282

STEP-3 Place the buffer tube into the holder

Hours: 9am-7pm (AEST), or 9am-8pm (AEDT), 7 days per week Website: www.touchaustralia.com.au Email: touch@touchaustralia.com.au

Carefully place extraction tube into tube holder or tube stand.

Address: 119 Willoughby Road, Crows Nest, NSW 2065

Open the lid.

Watch “How to Use Video” Scan the QR code for information on how to use the test.

DO NOT DRINK the extraction buffer liquid. If you accidentally drink it IMPORTANT immediately consult your healthcare professionals.
DO NOT SPILL any of the extraction buffer liquid. If you spill it, sterilize the area, and repeat the test by using new sampling swab and extraction solution tube.

RSV SARS-CoV-2
FLU A/B

C

C

C

A

T

T

B

15

x3

x3

x3

S

S

S

Test Cassette

(Device)

White Cap
Lid

Sterilized Swab

Buffer Liquid
Extraction Buffer Tube

Instructions for Use

Component required but not provided.

Tube Stand

Biohazard

Only 20 tests/kit package contains the tube stand. The other test kits

Specimen Bag have a holder for the tube.

STEP-4 Take the sterilized swab
Pull open the swab packaging at the marked point and remove the swab.
Soft Head of Swab
DO NOT TOUCH soft head of swab. DO NOT OPEN the swab until you are going to IMPORTANT use it immediately.

STEP-5 Sample Collection

Tilt your head back slightly

LEFT NOSTRIL

Gently insert the swab about 2cm into the left nostril. At least with the entire soft swab.
Gently rotate the swab at least 5 times against the nasal wall.
Do the same for the right nostril Gently insert the swab about 2cm. At least with the entire soft swab.
Gently rotate the swab at least 5 times against the nasal wall.
Remove the swab from the second nostril.

2 cm Rotate 5 times
RIGHT NOSTRIL
2 cm Rotate 5 times

IF YOU FEEL DISCOMFORT, STOP IMMEDIATELY.

IMPORTANT

If the swab stick breaks during the sample collection, please use a new swab. Do not insert the swab deeper if you feel strong resistance or pain.

STEP-6 Insert the swab

Rotate 10 times
Squeeze it 5 times

Insert the sampled swab into the extraction buffer tube, and dip the tip into the tube.
Rotate the swab tip 10 times along the inner wall of the buffer tube.
And squeeze the tip of the swab 5 times along the inner wall of the tube to keep as much liquid in the bottle as possible. .

STEP-7 Take out the swab
Remove the swab from the tube by squeezing the sides of the tube to release the liquid from the swab.

IMPORTANT

If squeezing of tube is not done correctly, sample swab absorbs much more liquid form the extraction buffer and that will yield wrong results.

Discard the swab in the biohazard specimen bag.

STEP-8 Close and Mix the tube

Squeeze it

STEP-10 Unscrew the white cap

Unscrew the white cap of the tube.

White

Cap

This allows drop-wise dispensing of

the liquid.

Turn up

STEP-12 Wait for result

Set timer and wait for

15

15 minutes.

Wait for 15 minutes

STEP-11 Test Operation
Add 3 drops of the extraction buffer tube to the FLU A/B sample well marked “S” on the test cassette.

Read the result at 15-20 minutes.

Read at 15-20 Minutes

DO NOT READ the result beforehand or after 20 minutes, even If a line has already appeared at the region “C”
IMPORTANT

Screw on and tighten the lid on the extraction tube.

And then shake the extraction tube vigorously to mix the specimen and the sample extraction buffer.

Ensure the lid is screwed on properly. Do not spill any of the sample extraction liquid.
IMPORTANT

STEP-9 Take out the cassette
Open the foil pouch and take out the test cassette.

Place it on a flat and clean surface.

FLU A/B Sample Well.

S

x3

B

A

C

STEP-13 Read your results

15

x3

S

C

T

x3

S

C

T

To read your test results, please go to the interpretation of the results Do the same for the SARS-CoV-2 sample well marked “S, add 3 drops. section provided below.

S

S

S

SARS-CoV-2 Sample Well.
Do the same for the RSV sample well marked “S, add 3 drops.

x3

x3

x3

15

B

T

T

A

C

C

C

STEP-14 Disposal
Please dispose all parts of the test kits and place them in the biohazard bag that can be disposed in the household waste or rubbish bin. If there are local regulations, please follow them.
STEP-15 Wash your hands

RSV SARS-CoV-2
FLU A/B
RSV SARS-CoV-2
FLU A/B
RSV SARS-CoV-2
FLU A/B

RSV SARS-CoV-2
FLU A/B

C

C

C

A

T

T

B

15

x3

x3

x3

S

S

S

Result window Sample well

Perform the test within 15 minutes 15

after the foil pouch is opened.

min.

IMPORTANT

RSV Sample Well.

S

S

S

x3

x3

x3

15

B

T

T

A

C

C

C

Wash your hands thoroughly after test completion.

Ensure to add at least 3 drops of the liquid from the specimen tube into the each sample well. IMPORTANT If adding less than 3 drops, that will yield wrong result.

Watch “how to use” video:
touchaustralia.com.au/pages/ifu-covid-flu-rsv

INTERPRETATION OF THE RESULTS

POSITIVE RESULTS

EACH TEST WINDOW (FLU A/B, SARS-CoV-2 AND RSV ) MUST BE READ INDEPENDENTLY FROM EACH OTHER.

NEGATIVE RESULTS

INVALID RESULTS

FLU A/B

FLU A/B

FLU A/B

SARS-COV-2

RSV

C

C

C

C

C

A

A

A

T

T

B

B

B

FLU A

FLU B FLU A+ B SARS-COV-2

RSV

Positive Positive Positive

Positive

Positive

THE SHADE OF LINES MAY VARY, BUT EVEN IF A FAINT/WEAK LINE APPEARS,
IT SHOULD BE CONSIDERED POSITIVE.
If you have a POSITIVE result, follow the guidance from your local State or Territory Health Department for guidance on confirmation testing if necessary, and if unwell seek medical assistance for SARS-CoV-2 and individuals with a positive result or who are unwell must consult a medical practitioner for follow-up clinical care for Influenza and RSV.

FLU A/B
C A B

SARS-COV-2
C T

RSV
C T

FLU A/B Negative

SARS-COV-2 Negative

RSV Negative

ONLY RED LINES APPEAR IN THE CONTROL REGIONS (C), AND NO LINE IN THE REGION
(A), (B), AND (T).
The negative result indicates that there are no Flu A/B, RSV and SARS-CoV-2 particles in the sample or the
number of viral particles is below the detectable range. Even if you get a negative result, you still need to follow all public health advice on limiting the spread Covid-19, Flu A/B and RSV. If symptoms persist, repeat testing and consult a medical practitioner for follow-up clinical care.

FLU A/B INVALID

C

C

C

C

A

A

A

A

B

B

B

B

SARS-CoV-2 INVALID

RSV INVALID

C

C

T

T

C

C

T

T

NO RED LINE APPEARS IN THE CONTROL REGION (C) FOR FLU A/B. The test is invalid even if there is a line
on the region (A), (B) or (A) and (B).

NO RED LINE APPEARS IN NO RED LINE APPEARS IN

THE CONTROL REGION (C) THE CONTROL REGION (C)

FOR SARS-COV-2.

FOR RSV.

The test is invalid even if there The test is invalid evenif there

is a line on the region (T).

is a line on the region (T).

WHEN NO RED LINE APPEARS IN THE CONTROL REGION (C) FOR ALL THREE TESTS, THE TEST IS INVALID FOR ALL THREE FLU A/B, SARS-COV-2 AND RSV.
Insufficient sample volume or incorrect procedural techniques are the most likely reasons for the control line (C) failure.
Review the test procedure and repeat the test using a new test device. If invalid result continues after repeating, please contact Touch Biotechnology on the provided contact
number or email for assistance.

NEED HELP with the TEST?

Before You Start
Do not open the foil pouch and swab packaging until you have read the instructions, and are ready to take the test. Use immediately upon opening. Will this test hurt?
No, the nasal swab is not sharp and it should not hurt. Sometimes the swab can feel slightly uncomfortable. If you feel pain, please stop the test and seek advice from a doctor. When should I perform the test after opening the foil pouch? You should perform the test within 15 minutes after opening the foil pouch.
Don’t know how long I should keep the swab out without using? Do not open the swab packaging until you are going to use it immediately.
What do you need to consider when storing the test kit? You can store the test kit at 2°C – 30°C temperature. Do not freeze and do not store the test kit in direct sunlight. All components must be bought to room temperature before testing. Do not use after expiry date.
Sample Collection
Do I need to insert the swab into my both nostrils to take sample? Yes, you must take the samples from your both nostrils.

Test Operation
How many drops should I add in both sample wells? You should add 3 drops using the buffer tube into all three samples wells noted as “S” on the cassette
Don’t know how long I should wait to read my results? Make sure you wait for 15 minutes, and then read your results at 15-20 minutes
Read Results
How do I know if the test was run properly? A coloured line will appear in the control region (C) of the test cassette if the test has been properly performed. If this line is not visible, then the test has been incorrectly performed and you must run a new test or call customer support.
There is a faint/weak line appearing at A, B or T, should this be still considered as positive?
Yes, even if there is a faint line at the region A, B or T or all, results must be considered as positive.
The red line appeared in the control (C) region only on some of the strip/s and did not appear on one or two strips. Does that mean the test is invalid for all 3 viruses?
No, it means test must be considered invalid only for those virus where red line is absent on control (C) region. Results are valid for any test where control region (C) is present.

Don’t know how deep I should insert the swab into my nostrils? Gently insert the swab about 2cm (soft head of the swab) into your nostrils.Do not insert the swab deeper if you feel strong resistance or pain.

Visit www.touchaustralia.com.au/pages/ifu-covid-flu-rsv to watch “how to use” video. If you have any specific questions, feedback or
suggestion,please contact us on the provided contact number or email address.

TouchBio RSV, FLU A/B & Covid-19
Rapid Antigen Combo Test (Nasal) REF: VMD71 An Antigen Rapid Test for the detection of SARS-Cov-2, Flu A/B and RSV in nasal swab. For Self-Testing use.
In-vitro diagnostic test for self-testing
Instructions for use
INTENDED USE
TouchBio RSV, FLU A/B & Covid-19 Rapid Antigen Combo Test (Nasal) is an in vitro immunochromatographic assay for the qualitative detection of antigens in nasal swab specimens collected from patients against the respiratory infection for SARS-CoV-2 (within the first 7 days of the onset of symptoms) and influenza A/B or Respiratory syncytial virus (RSV) (within the first 4 days of the onset of symptoms). This test is intended for use as an aid in the differential diagnosis of SARS-CoV-2 and influenza A/B or Respiratory syncytial virus (RSV) viral infections in humans in conjunction with clinical and epidemiological risk factors. The test does not require any special training for sample collection, processing, or test operation. TouchBio RSV, FLU A/B & Covid-19 Rapid Antigen Combo Test (Nasal) is intended to be used by laypersons as a self-test. The test can be performed by individuals older than 18 years old and users between 4-18 years old required guidance by adults. This kit is not suitable for children under 4 years old.
PRINCIPLE OF THE TEST
TouchBio RSV, FLU A/B & Covid-19 Rapid Antigen Combo Test (Nasal) is an immunochromatographic membrane assay and contains 3 independent tests, the SARS-CoV-2 antigen test, FLU A/B antigen test and RSV antigen test. In the test procedure, a specimen is collected by nasal swab and placed onto sample well of test cassette as 3 drops then allow the solution in the sample well to migrate through the pads containing highly sensitive detector antibodies conjugated to gold dye for detection of nucleocapsid antigens.

MATERIALS AND COMPONENTS

Materials required and provided with the test kits

COMPONENT

1 TEST KIT

2 TESTS KIT

5 TESTS KIT

20 TESTS KIT

Test Device

1 Test cassette

2 Test cassettes

5 Test cassettes

20 Test cassettes

(1 Test/pouch x 1 pouch) (1 Test/pouch x 2 pouches) (1 Test/pouch x 5 pouches) (1 Test/pouch x 20 pouches)

Extraction Buffer Tube

1 single-use bottle,
each with 500 µL extraction buffer

2 single-use bottles,
each with 500 µL extraction buffers

5 single-use bottles,
each with 500 µL extraction buffers

20 single -use bottles,
each with 500 µL extraction buffers

1 sterile, single use Sterilised Swab specimen sampling
swab

2 sterile, single use specimen sampling swabs

Biohazard Specimen Bag

1 biohazard specimen bag

2 biohazard specimen bags

Instructions For Use
Tube Stand

1 instructions for use 1 instructions for use

5 sterile, single use specimen sampling swabs

20 sterile, single use specimen sampling swabs

5 biohazard specimen bags

20 biohazard specimen bags

1 instructions for use

4 instructions for use

1 Tube Stand

Materials required but not provided with the test kit -Timer

STORAGE AND STABILITY
1. Store the test kit at 2°C – 30°C. DO NOT FREEZE and DO NOT STORE the test kit in direct sunlight. All components must be brought to room temperature before testing. 2.The test cassette must be used within 15 minutes after removal from the foil pouch. 3. DO NOT USE after the expiry date. The expiry date is stated on the label/packaging.
LIMITATIONS
1. Each test can only be used once 2. Test results must be read at 15 minutes and no later than 20 minutes. 3. A negative result does not rule out infection with another type of respiratory virus (other than SARS-Cov-2, Influenza A/B and RSV). 4. A negative result does not mean a person is not infectious or does not have COVID-19, Influenza A/B or RSV. If symptoms persist the person should seek medical attention and further testing if required. 5. Positive test results do not rule out bacterial infection or coinfection with other viruses

6. A false negative test may result if the level of antigen in the sample is below the detection limit of the test or if the sample was collected incorrectly. 7. If the result is positive for SARS-CoV-2, please contact the relevant state or territory health authority for guidance on confirmation testing. 8.If positive for Influenza A/B or RSV are feeling unwell, consult a medical practitioner for follow-up clinical care.. 9. The test is less reliable in the later phase of infection and in asymptomatic individuals. 10. Children aged 4-18 years old should have the samples collected and tested by an adult. Do not use on Children under 4 years of age. 11. False negative results are more likely to occur if the test is performed after 7 days of symptom onset for SARS-CoV-2 and after 4 days of symptom onset for Influenza A/B and RSV. 12. Even if the result is negative, you still need to observe all protective and hygienic measures, 13. Repeat Testing is recommended (between 24-48 hours after your first test if there is ongoing suspicion of infection, being high risk settling or where there is an occupational risk or other requirement. 14. Influenza and RSV self-testing is for use as an aid for diagnosis only and individuals with a positive result or who are unwell are advised to consult a medical practitioner for follow-up clinical care.
QUALITY CONTROL
A colored line in the control area (C) is considered an internal process control. It confirms complete penetration of the membrane with the sample, reactivity of the reagents, and correct test performance.
PERFORMANCE CHARACTERISTICS
Clinical Study Performance The clinical performance of the kit was determined by comparison with an RT-PCR assay. Individual kits used in the clinical performances included combination antigen rapid test for COVID-19+FLU A/B and antigen rapid test for RSV. Samples were taken within first 4 days of symptoms onset for Influenza A+B, RSV and samples taken within 7 days of symptoms onset for SARS-CoV-2. The performance of the kit was assessed with 261 positive SARS-CoV-2 case, 223 positive cases of RSV 160 positive Influenza A case, and 120 positive influenza B case by nasal swabs.

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

Results for Influenza A: The sensitivity is 98.39% and the specificity is 100.0%. The accuracy of the test kit
is calculated as 99.21%.

RSV, FLU A/B & Covid-19 Rapid Antigen Combo Test
Positive Negative Total

RT-PCR comparison method

Positive

Negative

Total

183

0

183

3

195

198

186

195

381

Results for Influenza B:
The sensitivity is 98.86% and the specificity is 100.0%. The accuracy of the test kit is calculated as 99.46%.

RSV, FLU A/B & Covid-19 Rapid Antigen Combo Test
Positive Negative Total

RT-PCR comparison method

Positive

Negative

Total

174

0

174

2

195

197

176

195

371

RSV:
TouchBio RSV, FLU A/B & Covid-19 Rapid Antigen Combo Test
Positive Negative Total Sensitivity Specificity Accuracy

Positive 220 3
223 98.65% 99.57% 99.12%

RT-PCR comparison method

Negative

Total

1

221

230

233

231

454

95% CI 96.12% to 99.72%

95% CI 97.61% to 99.99%

95% CI 97.76% to 99.76%

Usability Study Performance

A total of 778 layusers took part in the TouchBio RSV, FLU A/B & Covid-19 Rapid Antigen Combo Test (Nasal) study. Results are summarized below.

Results for SARS-CoV-2: The sensitivity is 98.28% and the specificity is 99.49%. The accuracy of the test kit is calculated as 99.04%.

RSV, FLU A/B & Covid-19 Rapid Antigen Combo Test
Positive Negative Total

RT-PCR comparison method

Positive

Negative

Total

114

1

115

2

194

196

116

195

311

Results for RSV:
The sensitivity is 97.14% and the specificity is 99.49%. The accuracy of the test kit is calculated as 98.67%..

RSV, FLU A/B & Covid-19 Rapid Antigen Combo Test
Positive Negative Total

RT-PCR comparison method

Positive

Negative

Total

102

1

103

3

194

197

105

195

300

Analytical Performance
1.Limit of Detection (LOD) The minimum detection limit of the TouchBio RSV, FLU A/B & Covid-19 Rapid Antigen Combo Test (Nasal) is 100 TCID50/mL for SARS- CoV-2 infections. For Influenza A, the detection limit is minimum 1.0×102 TCID50 /mL (A/Victoria/3/75) and maximum 5.0×104 TCID50/mL (A/ HK/403946/09) and for Influenza B, the detection limit is minimum 6.0×10² TCID50/mL(B/1704) and maximum 4.0×104 TCID50/mL (B-Yamagata). For RSV, the detection limits is 240 TCID50/mL.
2.Variants 2.1.SARS-CoV-2 B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma), B.1.617.2 (Delta), B.1.1.529 (Omicron).

2.2 Influenza A variants H1N1, H3N2, H1N1pdm09, A/Taiwan/42/06, A/HongKong/8/68, A/Victoria/3/75, A/14160, A/HK/403946/09, A/44045, A/924, A/Beijing/302/54, A/swine/ Guangdong/2/01, S-OIV A/HK/415742/09, S-OIV A/California/4/09.

In silico analysis:

6.The sample buffer and test cassette must be brought to room temperature

For Human Coronavirus HKU1, homology exists between the SARS-COV-2 (18°C~30°C) before use, otherwise the results may be false.

nucleocapsid protein and Human Coronavirus HKU1. Blast results showed 7.Discard and do not use any damaged or dropped Test Card or material.

36.6% homologous across 82% of the sequence.

8.Users should test specimens as soon as possible after collection

This is relatively low but cross-reactivity cannot be fully ruled out.

if the sample does not store in sample extraction solution.

Blast results showed no homology or sequence similarity between RSV 9.Do not spill any of the sample extraction solution. If you spill it, sterilize

2.3.Influenza B variants

sequenece and HKU1, Mycobacterium tuberculosis & Pneumocystis

the area and if the amount of the sample extraction solution mixture is not

B-Victoria, B-Yamagata, B/1715, B/1704, B/179, B/668, B/Taiwan/2/62, jirovecii.

enough to perform the test, repeat the test bey using new sampling swab

B/ Malaysia/2506/2004.

and extraction solution tube.

2.4.Respiratory syncytial virus (RSV) Variants RSV A and RSV B.

3.2.Interference Substances The test results are not interfered by the substance in the following concentration. Whole Blood, Mucin, Benzocaine, Menthol, Zanamivir

10.Do not drink the extraction solution in the tube with or without swab. Immediately consult your healthcare professional if you drink it. 11.If the sample volume is insufficient, the assay will not perform

Mupirocin, Tobramycin, Fluticasone, Beclomethasone, Dexamethasone, successfully.

3.Analytical Specificity

Flunisolide, Triamcinolone, Mometasone, Sodium Chloride with preservative, 12.The Reagent Solution contains a salt solution (saline). If the solution

3.1.Cross Reactivity

Phenylephrine, Afrin (Oxymetazoline), Ibuprofen, Tetracycline,

contacts the skin or eye, flush with copious amounts of water.

The cross-reactivity of the kit was evaluated. The results showed no

Chloramphenicol, Erythromycin, Arbidol, Ribavirin, Histamine

13.Inadequate or inappropriate storage and transport of all components

cross-reactivity with the following samplesthe following samples.

dihydrochloride, Throat spray (Menthol), Mupirocine, Ice throat candy

and sample collectionmay yield false test results.

Adenovirus Type 3, Adenovirus Type 5, Adenovirus Type 7,

(Menthol), Tamiflu (Oseltamivir), Naphazoline hydrochloride nasal drops, 14.To obtain accurate results, do not use visually bloody or overly viscous

Human Parainfluenza Type 1,Human Parainfluenza Type 2, Human

Fisherman’s Friend, Cromoglycate, Sinex (Phenylephrine Hydrochloride), specimens.

Parainfluenza Type 3, Human Parainfluenza Type 4, Human coronavirus Fluticasone propionate spray, Chloraseptic (Menthol/ Benzocaine),

15.To obtain accurate results, an opened and exposed Test Card should not

OC43, Human coronavirus NL63, Human coronavirus 229E, Respiratory NasoGEL (NeilMed), CVS Nasal Spray (Cromolyn), Saline Nasal Spray, be used in a heavily ventilated and moisture area.

syncytial virus Type A, Respiratory syncytial virus Type B, Rhinovirus

Zicam Cold Remedy, Homeopathic (Alkalol), Sodium Cromolyn Eye

16.Wash hands thoroughly after handling.

Type 1,Rhinovirus Type 14, Rhinovirus B70, Enterovirus CA16, Enterovirus Drops, Alkalol Nasal Wash, Throat Lozenge, Sore throat phenol throat

17.Do not touch the sample well or the membrane of the test cassette.

70, Avian influenza virus H7N9, Avian influenza virus H5N1, Human

spray.

18.Keep out of reach of children

para-flu virus Type 1, Human para-flu virus Type 2, Human para-flu virus

Type 3, Human para-flu virus Type 4, Cytomegalovirus, Measles virus,

PRECAUTIONS

Boca virus, Mumps virus, Epstein Barr Virus, Herpes simplex virus (HSV-1),

Varicella-zoster virus, Human metapneumovirus, MERS coronavirus,

1.For self-testing in-vitro diagnostic use only.

SARS-coronavirus, Human coronavirus (HKU1), Bordetella pertussis, 2.Do not use the kit contents beyond the expiration date printed on

Bordetella parapertussia, Staphylococcus epidermidis, Staphylococcus the outside of the box.

aureus, Staphylococcus pneumoniae, Streptococcus pyogenes,

3.Do not reuse the used Test Card, Reagent Tube or Swab.

Streptococcus pneumoniae, Streptococcus salivarus, Escherichia coli, Candida albicans, Mycobacterium tuberculosis, Paramyxovirus parotitis, Pneumocystis jirovecii, Moraxella catarrhalis, Pseudomonas aeruginosa, Pneumocystis, Legionella pneumophila, Corynebacterium pneumophila, Lactobacillus pneumophila, Klebsiella pneumoniae, Mycoplasma pneumoniae, Chlamydia pneumoniae, Neisseria pneumophila, Neisseria meningitides, Haemophilus influenza.

4.The aluminum pouch includes a test cassette and a silica gel. Silica gel is required for protect test cassette against environmental conditions. Do not use the test kit if the aluminum pouch does not include silica gel. Do not swallow the silica gel. When swallowed, immediately consult your healthcare professional. 5.All users must read the instructions for use carefully before carrying out the test.

Australia Sponsor & 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
Code:RSV-IFU Date of Issue:21.04.2023 Version: 01202303_07

References

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