touch BIO VMD71 RSV FLU A-B and Covid-19 Rapid Antigen Combo Test Instruction Manual
- October 30, 2023
- touch BIO
Table of Contents
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: [email protected]
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:
[email protected] Address: 119
Willoughby Road, Crows Nest, NSW 2065
Code:RSV-IFU Date of Issue:21.04.2023 Version: 01202303_07
References
- How to use Covid-19, Flu A/B and RSV Rapid Antigen Test | TGA App.
- Surface and Hand Disinfectants, Covid-19 and Flu Tests | TouchBio
- How to use Covid-19, Flu A/B and RSV Rapid Antigen Test | TGA App.