Procalcitonin PCT Rapid Test Kit Vitro Diagnosis Used Clinically For Auxiliary Diagnosis

[Product Name]PCT.pdf

Procalcitonin (PCT) Rapid Quantitative Test (Fluorescence immunoassay)

[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.

[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.

【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.

【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 .