CLUNGENE COVID-19 Influenza+B Antigen Combo Rapid Test Instruction Manual
- June 9, 2024
- CLUNGENE
Table of Contents
COVID-19 Influenza+B Antigen Combo Rapid Test
Instruction Manual
For Australia Only
CLUNGENE® COVID-19 /Influenza A+B Antigen
Combo Rapid Test
COVID-19 Influenza+B Antigen Combo Rapid Test
Specification: 1, 2, 5, 20 Tests/box
COVID-19 /Influenza A+B Antigen
Combo Rapid Test (For Self-testing)
Product Features
- Results are clearly visible.
- Results provided withing 15-20 minutes.
- No requirements for an instrument.
Product Information
PACKING CARTONINFORMATION
| SPECIFICATION | MEAS/CTN | TESTS/CTN | ESTIMATED G.W./CTN |
|---|---|---|---|
| 1 test/box | 5445.529 cm | 400 tests | 12.5 kg |
| 2 tests/box | 584837 cm | 1000 tests | 19.5 kg |
| 5 tests/box | 594058 cm | 1200 tests | 25.3 kg |
| 20 tests/box | 643449.5 cm | 1000 tests | 19.5 kg |
Preparation
Open the box and you will get the components shown below.
Wash your
hands in soapy water and dry thoroughly.
Step-By-Step Instructions
- Open Extraction Reagent Tube
- Insert Tube into Box
- Remove the Swab
- Swab the Left Nostril
- Swab the Right Nostril
- Insert the Swab into the Tube
- Rotate the Swab 5 Times Let the tip of the swab soak in the tube for 1 minute.
- Remove the Swab
- Take out the Test Cassette from the pouch
- Add Sample to the Sample Well 11. Start the timer and wait 15 minutes.
Read the test result at 15-20 minutes.
DO NOT read the result after 20 minutes.
Interpretation of Results
Positive Result
• For COVID-19 Antigen Rapid Test Two lines appear.
One colored line appears at the control region (C), and another colored line
appears at the test region (T).
For Influenza A+B Antigen Rapid Test
Flu A Positive.
One colored line appears at the control region (C), and another
colored line appears at the A test region.
Flu B Positive.
One colored line appears at the control region (C), and another
colored line appearsat the Btest region.
Flu A & B Positive.
One colored line appears at the control region (C), and both the A
and B lines appear at the test region.
**Negative Result
**
For COVID-19 Antigen Rapid Test
For Influenza A+B Antigen Rapid Test
Both:
One colored line appears at the control region (C), and no lines appear at the
test region.
Invalid Result
For COVID-19 Antigen Rapid Test
For Influenza A+B Antigen Rapid Test
Both: Control line fails to appear.
Clongene is a high-tech enterprise specialized in biological raw materials and
in vitro diagnostic products. Founded in 2004, Clongene is equipped with
state-of-the-art ISO 13485:2016 accredited- China GMP compliant R&D and
manufacturing facilities covering 19,000 square meters in Hangzhou, China. Our
products have obtained CE certificates, FSC certificates and US FDA 510(k)
clearances.
About
US
Clongene keeps growing and pays much attention to the R&D of raw materials and
in vitro diagnostic products with the aim of bringing more value to our
clients. Our technology platform sincluding colloidal gold immunoassay (CGIA),
chemiluminescence immunoassay (CLIA), fluorescence immunoassay (FIA) and
molecular diagnosis (RT- PCR). We are committed to build multi-field service
platform of ‘raw materials+ IVD reagetns+instruments’.
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