FluB Real Time Kits One Step Assay FIA Rapid Quantitative Test Kit in oropharyngeal swab samples

2. Collection of throat secretions: insert the throat completely from the mouth, take the throat wall and the red part of the maxillary amygdala as the center, wipe the bilateral pharyngeal tonsils and the posterior pharyngeal wall with moderate force, avoid touching the tongue, and take out the swab.

3. After the collection of samples, the virus sampling solution or the sample extraction solution provided by this kit shall be used for treatment as soon as possible. If the specimen cannot be processed immediately, it shall be stored immediately in a dry, sterilized and tightly sealed plastic tube. It can be stored for 8 hours at 2℃ ~ 8℃ and for a long time at - 70℃.

【Test procedure】

Please read the operating instructions carefully before testing. Please restore all tests to room temperature before the test. The test shall be carried out at room temperature.

1. Insert the swab after sampling into the sample buffer and rotate it close to the inner wall of the test tube for about 10 times to make the sample dissolve in the solution as much as possible.

2. Squeeze the cotton swab head of the swab along the inner wall of the extraction tube to keep the liquid in the tube as much as possible. Break the tail of the swab, cover the extraction tube cover, and break the upper part of the extraction tube after mixing.

3. Open it along the opening of the aluminum foil bag, take out the reagent card and place it flat.

4. Drop 80 µL (about 3-4 drops) of treated sample extract into the sampling hole of the test card or directly add 80 µL of treated virus culture medium.

5. Observe the displayed results within 15 ~ 20 minutes, and the results displayed after 30 minutes have no clinical significance.

【Interpretation of results】

1. FluA positive: two red reaction lines appear, one in zone B and one in Zone C (quality control area).

2. Negative: only one red reaction line appears in area C of quality control area, and no visible red / pink band appears in B area

5. Invalid: there is no red reaction line in the quality control area (c), and the inspection is invalid. It is recommended to retest with a new test card at this time

Note: the color development depth of the reaction line is related to the content of the tested substance contained in the extracted sample. Regardless of the color intensity, the result shall be determined according to whether the reaction line is color developed or not.

This reagent contains quality control process. When a red reaction line appears in Zone C, it indicates that the operation is correct and effective, otherwise the detection is invalid.

【Performance】

1. Limits of detection

No higher than 1.0 ×10²TCID₅₀ /ml.

2. Sensitivity:

95.24% (91.75%～97.14%)

3. Specificity:

100.00% (96.34%～100.00%)

【Note】

1. This product is a disposable in vitro diagnostic reagent. Do not use expired products.

2. There is no color band on the quality control line and inspection line, indicating that there is an error and the detection should be retried.

3. Avoid the high temperature of the test environment. The test card stored at low temperature needs to be restored to room temperature and then opened to avoid moisture absorption.

4. It is recommended to use fresh samples instead of repeated freeze-thaw samples.

5. For sampling, please use the sub sample and sample extract provided by this test box. Do not mix different batches of test cards and sample buffer.

6. If the virus sampling solution is used to treat the sample, it can be detected directly without diluting the sample extraction solution.

7. For the detection of influenza B virus or subtypes, the small change of antigen epitope caused by small-scale mutation of nucleic acid sequence may lead to the reduction of clear results or the analytical sensitivity of reagents.

8. Pay attention to safety measures during operation, such as wearing protective clothing, gloves, etc. The used swabs, test cards and extraction tubes shall be decontaminated before being discarded. It is recommended to disinfect them with high-pressure steam.

Interpretation of Test Results

1. The kit can be used for auxiliary test only. If test result is abnormal, retest timely and judge combined with clinical symptoms.
2. For samples whose cTnI concentration is lower than 0.1ng/mL and higher than 40ng/mL, test result is “＜0.1ng/mL” and “＞40ng/mL” respectively.

Advantage

1. Advanced Quality: We have strict quality control system and enjoy good reputation in the market.

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