PCT Rapid Test Kit Fluorescence Immunoassay Test Cassette

[Product Name]

Procalcitonin (PCT) Rapid Quantitative Test (Fluorescence immunoassay)

[Packing Specification]

25 Tests/kit

Product Performance Indicators]

1. Limit of detection

No more than 0.2ng/mL

2. Accuracy

The relative deviation to the target value is limited to ±15%.

3. Precision

Within-run precision CV≤15%; between-run relative limit R≤15%.

4. Linearity range

Within the specified linearity range (0.2-100) ng/mL, linearly dependent coefficient r≥0.990.

[Main Ingredients]

Ingredients of kits of different batch numbers cannot be exchanged.

[Storage Conditions and Validity]

The product should be stored at 4℃-30℃ in a dry and dark place, sealed using aluminum foil bag and must not be frozen. The storage life is 12 months. The test card should be unpacked at room temprature (15℃-30℃) and should be used in 15min after unpacked at a temperature of (15-30)℃ and relative humidity of 20%-90%.

See outer packing for production date, batch number and expiry date.

[Test Method]

1. Please thoroughly read the specification before test. Frozen test card and sample should be placed at room temperature (15-30)℃ for at least 30min before use.
2. Start NIR-1000 dry fluoroimmunoassay analyser and verify quality control according to the specification. (Note: Reagent has been calibrated in advance and calibration curve parameters of each batch of reagents have been stored in the information card. Insert the information card before use and carry out test without re-calibration after passing quality inspection; otherwise, identify the cause before test.)
3. Take out the test card from the aluminum foil bag and use it within 15min
4. Place the test card on a clean horizontal table top and label it.
5. Take 100μL of sample and add it into 300μL of buffer solution (1:3). Then, mix the solution evenly, take 100μL of the solution and add it into the test card well.
6. Insert the test card into NIR-1000 dry fluoroimmunoassay analyser and press “Timing test” to keep time for 10min automatically. The analyzer will judge and read the test result automatically and display it in the screen. Or insert the test card into the analyzer after 10min and press “Instant test”, the instrument will judge and read the result automatically.

Interpretation of results

1. This reagent is only used for auxiliary detection. If the test results are abnormal, it should be reviewed in time and judged in combination with clinical symptoms.
2. For samples with AFP concentration lower than 2.5ng/ml and higher than 200ng/ml, the detection results are reported as "< 2.5ng/ml" and "> 200ng /ml", respectively.

Limitations of methods

1. This kit is only used to detect human plasma/whole blood samples
2. Due to the limitations of immunoassay methods of antigen and antibody reaction, the results cannot be used as the only basis for clinical diagnosis, but should be evaluated with all the existing clinical and experimental data.
3. The content of triglyceride in the sample shall not exceed 15mg/ml, the content of hemoglobin shall not exceed 5mg/ml, and the content of bilirubin shall not exceed 0.5mg/ml, and the relative deviation of the test results shall not exceed ±15%.
4. When the concentration of AFP in the sample is less than 20000ng/ml, there is no hook effect.
5. HAMA effect was not produced when the concentration of human anti rat in the sample was less than 50ng/ml.
6. When RF concentration in the sample is less than 2000IU/ml, the relative deviation of the test results is within ±15%.
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Applicable Instrument

WWHS NIR-1000 dry fluoroimmunoassay analyser

Notice

1) The test card can be used only once at room temperature, do not reuse or use test card out of expiry date.

2) Return all reagents and sample into room temperature before use.

3) Be careful when prepare sample, wear glove and mask.

4) The whole blood need add anticoagulants, not frozen; serum sample can store in frozen, avoid repeated freezing and thawing.

5) This product is only for in vitro rapid diagnostic human use, can be quantified, not only qualitative testing.

6) The product test results for reference only, for confirmation, please refer to the relevant national standard methods.