PCT Rapid Test Kit Fluorescence Immunoassay Test Cassette

[Product Name]

Procalcitonin (PCT) Rapid Quantitative Test (Fluorescence immunoassay)

[Packing Specification]

25 Tests/kit

[Intended Use]

The product is used to determine the content of procalcitonin (PCT) in whole blood, plasma and serum of human body and is mainly used clinically for auxiliary diagnosis of bacterial infectious diseases.

[Test Principle]

The kit uses immunochromatographic assay. First, PCT antigen in the sample combines with the fluorescently-labeled PCT monoclonal antibody conjugate. Then, it continues to move and combines with another PCT monoclonal antibody fixed on the nitrocellulose membrane to form double-antibody sandwich immune complex in the position of the nitrocellulose membrane test line and analyze and obtain quantitative test result using NIR-1000 dry fluoroimmunoassay analyser.

[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.

[Applicable Instrument]

NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech. Inc.

[Sample Requirements]

1. Serum and EDTA·Na₂ anticoagulant plasma and whole blood, EDTA·K₂ anticoagulant plasma and whole blood, sodium citrate anticoagulant plasma and whole blood can be used.
2. Collect venous blood using coventional laboratory method. Clinical samples should be tested at room temperature (15℃-30℃) in 4h after collected. Whole blood specimens can be stored at (2-8)℃ for 24h; serum or plasma specimens can be stored at (2-8)℃ for 7 days and at -20ºC for 30 days.
3. The sample must be rewarmed to room temperature (15-30)℃ before test. Frozen samples should be completely melted, rewarmed and mixed before use and should not be frozen repeatedly.
4. Please do not test samples of severe hemolysis, severe lipoidemia and icterus.

[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.

【Reference Interval】

Determine 254 healthy people aged 18-68 and carry out statistical analysis. Result shows that the upper limit of the reference value is 0.5ng/mL at the 95^th percentile, so the reference interval is less than 0.5ng/mL.

The laboratory should establish a reference range according to characteristics of local people.

[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 PCT concentration is lower than 0.2ng/mL and higher than 100ng/mL, test result is “＜0.2ng/mL” and “＞100ng/mL” respectively.

[Limitation of Test Method]

1. The kit can be used to test whole blood, plasma and serum specimens of human body only.

2. Due to limitations of serological methods for antigen and antibody response, the test result cannot be used as the only basis for clinical diagnosis and should be evaluated together with all existing clinical and experimental data.

3. The content of triglyceride contained in the sample is no more than 10mg/mL, that of hemoglobin is no more than 6mg/mL and that of hemoglobin is no more than 0.6mg/mL, and the relative deviation is limited to ±15%.
4. When PCT concentration of samples is less than 250ng/mL, Hook effect is not observed.

5. When human anti mouse concentration of samples is less than 50ng/mL, HAMA effect will not be observed.

6. When RF concentration of samples is less than 2000 IU/mL, the test result will not be affected.

[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.

【Precautions】

1. Test card is single-use and it cannot be reused.
2. Please inspect packaging integrity and validity of kit before use and then unpack the product. If the product is stored at low temperature, restore to room temperature (15℃-30℃) before unpacking and use. Reagent cannot be used if packaging is damaged and the validity period expires.
3. Take the test card out of the aluminum foil bag and carry out experiment in 15min. Do not place it in the air for a long time to avoid dampness.
4. It is required to strictly comply with the requirements for sample collection and storage. If the sample is turbid, please centrifuge and precipitate it before use.
5. The kit contains products from animals. Eligible information about animal source and sanitary condition cannot absolutely ensure inexistence of infectious pathogen. Therefore, these products should be disposed of as latent infective material, and all samples, reagents and latent contaminants should be disinfected and disposed of according to relevant local regulations.
6. Too high or too low hematocrit of red cells may affect whole blood test result, so verification should be conducted using other methods .

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.