Singclean Rapid AG Diagnostic Combo & Flu a/B Antigen Test (Colloidal Gold Method) CE Marked

Combo& FLU A/B Rapid Test Kit, AG Test, Antibody Test Strip CE/White List

INTENDED USE

Combo & FLU A/B Antigen Test Kit (Colloidal Gold) is used for in vitro qualitative detection of 2019
Novel Combo antigen and influenza A/B antigen in human nasopharyngeal swab samples.

PACK FORMATS

1 Test/Box

10 Tests/Box

20 Tests/Box

50 Tests/Box

INTRODUCTION

Combo is an acute respiratory infectious disease.
The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia
and diarrhea are found in a few cases.
Influenza A/B viruses (Flu A/B) can cause acute respiratory infections, and people are generally susceptible.
These two viruses are highly contagious, spread quickly, have a short incubation period, and have a
high incidence. The main symptoms are fever, dry cough, fatigue, etc.

MATERIALS SUPPLIED

1. Test Cassette

2. Sampling cotton swabs (as nasopharyngeal swab)

3. Antigen extraction buffer

4. Antigen extraction tube

5. Paper workbench(The small one-test-box can be used as a workbench)

6. Instruction for use

STORAGE AND STABILITY

The kit can be stored at 4-30°C. The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use.

Do not freeze. Do not use beyond the expiration date. After opening the sealed pouch, use the test as soon as possible within 60 minutes.
 

SPECIMEN COLLECTION

1. Combo & FLU A/B Antigen Test kit(Colloidal Gold)can be performed using nasopharyngeal swab.

2. Testing should be performed immediately after specimen collection.

3. Bring specimens to room temperature prior to testing.

4. If specimens are to be shipped, they should be packed in compliance with local regulations covering the transportation of etiologic agents.
 

TEST PROCEDURE

Allow test cassette, antigen extraction buffer, specimen and/or controls to equilibrate to room temperature
(15-30°C) prior to testing.
1. Ask the patient to remove the secretions on the surface of the anterior nasal cavity, keep the head
slightly tilted, and gently and slowly insert the swab through the nasal cavity to the nasopharynx, When
resistance is encountered, it will reach the posterior nasopharynx, stay for a few seconds to absorb
secretions, and gently rotate to remove the swab.
2. Place the antigen extraction tube on the workbench. Place the antigen extraction buffer bottle vertically
downward, squeeze the bottle to make the buffer drip freely into the antigen extraction tube without
touching the edge of the tube, and add 8 drops (about 300ul) to the antigen extraction tube.
3. Put the swab specimen into the antigen extraction tube pre-added with the antigen extraction buffer,
and rotate the swab about 10 times while pressing the swab head against the tube wall to release the
antigen in the swab, then let it stand for about 1 minute.
4. Remove the swab while squeezing the tip of the swab so that as much liquid in the swab can be
discharged as possible. Dispose of used swabs in accordance with biohazard waste disposal methods.
5. Install the dripper on the antigen extraction tube and cap it tightly, and let it stand for about 1 minute.
6. Remove the test cassette from the sealed foil pouch and use it as soon as possible.
7. Place the test device on a clean and level surface.
8. Transfer 3 drops(about 100ul) of mix liquids to the sample well of the test card (or use a pipette to add
100ul), and start the timer.
9. Wait for the test result of the reagent. The result should be read in 15 minutes. Do not interpret the
result after 20 minutes.

INTERPRETATION OF RESULTS

For Combo Antigen test kit:
NEGATIVE:
If only the C band is present, the absence of any burgundy color in the T band indicates that no Co
antigen is detected in the specimen. The result is negative.
POSITIVE:
In addition to the presence of C band, if T band is developed, the test indicates for the presence of
Co antigen in the specimen. The result is Co positive.
INVALID:
Control line fails to appear. 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.
For Flu A/B Antigen test kit:
NEGATIVE:
If only the C band is present, the absence of any burgundy color in the T band indicates that no Flu A/B
antigen is detected in the specimen. The result is negative.
POSITIVE
FLU A/B positive:
In addition to the presence of the C-line, If the test lines A and B appears at the same time, it means that
there are both influenza A virus antigen and influenza B virus antigen in the sample, that is, the result is
positive for FLU A and FLU B.
FLU A positive:
In addition to the presence of the C-line, if the test line A appears, the test indicates the presence of FLU
A antigen in the sample, that is, the result is positive for FLU A.
FLU B positive:
In addition to the presence of the C-line, if the test line B appears, the test indicates the presence of FLU
B antigen in the sample, that is, the result is positive for FLU B.
INVALID:
Control line fails to appear. 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.
 

LIMITATIONS

1. Use fresh samples whenever possible.

2. Optimal assay performance requires strictly adherence to the assay procedure described in Instruction for use. Deviations may lead to aberrant results.

3. A negative result for an individual subject indicates absence of detectable FLU A/B antigen. However, a negative test result does not preclude the possibility of exposure to or infection with FLU A/B.

4. A negative result can occur if the quantity of the FLU A/B antigen present in the specimen is below the detection limits of the assay, or failed to collect the FLU A/B antigen in the nasal cavity of the patient.

5. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.