Procalcitonin (PCT) Test Kit (Homogeneous Chemiluminescence Immunoassay)

【Product Name】

Procalcitonin (PCT) Test Kit (Homogeneous Chemiluminescence Immunoassay)

【Packing Specification】

25 servings/?box

【Intended Use】

Procalcitonin (PCT) is a 116 amino acid prohormone with a molecular weight of approximately 12.7 kDa. PCT is expressed by neuroendocrine cells (C cells of the thyroid, pulmonary and pancreatic tissues) and successively enzymatically cleaved into (immature) calcitonin, katacalcin, and an N-terminal region. The blood of healthy individuals contains only low levels of PCT. It was discovered that PCT increases during bacterial infection.

It is probable that multiple tissues express PCT throughout the body in response to sepsis as was shown in an animal model. PCT circulating in septic patients consists of only 114 amino acids lacking the N-terminal dipeptide Ala-Pro.

Increased PCT levels are often found in patients suffering from bacterial sepsis, especially severe sepsis and septic shock. PCT is considered as a prognostic marker to support outcome prediction in sepsis patients.

In acute pancreatitis PCT was found to be a reliable indicator of severity and of major complications.?In patients suffering from community-acquired respiratory tract infections or ventilator-induced pneumonia PCT has been proposed as a guide for the decision of antibiotic treatment necessity and to monitor treatment success.

【Principle】

Sandwich principle.

The Procalcitonin (PCT)?test kit employs a wash-free and homogeneous strategy based on proximity hybridization-regulated CRET(Chemiluminescence resonance energy transfer). The AE demonstrated strong chemiluminescence (CL) in the presence of H2O2. Graphene oxide (GO) as an excellent quencher was used to produce the “Signal off” mode that little CL emission was observed through CRET between GO and the AE-labelled DNA3. Once the antigen was introduced, the target-induced proximity hybridization occurred to form a proximate complex, which inhibited the CRET by preventing GO from absorbing AE-labelled DNA3. The CL intensity increased with the increasing PCT?concentration.

【Main Components】

Lyophilized sphere reagents: DNA1-labeled PCT1 antibody (mouse) (≤1.0ug/mL), DNA2-labeled PCT2 antibody (mouse) (≤1.0ug/mL), DNA3-labeled acridine ester (AE), graphene oxide (GO) conjugated antioxidant (AOD), preservative (P300) (0.1%).

Calibration card: containing standard curve for product calibration.

※The components in the kits of different batches are not interchangeable.

2?Reaction cups

2?Compound solution

2?Substrate solution

2?Pipette

2?Disposable tip

【Storage Conditions and Expiration Date】

Stable for 18?months when stored at 2-8℃?away from light. Reagents are used immediately upon opening.

【Applicable Instruments】

Chemiluminescence immunoassay analyzer (HSCL-5000)?produced by Nanjing Poclight?Biotechnology Co.?Ltd.

【Sample Requirements】

1. The serum is recommended to be collected by ordinary serum collection tubes or tubes with procoagulant. If it cannot be used immediately,?it is recommended to be stored at 2-8℃ and the test should be completed within 24 hours. If the test cannot be performed within 24 hours, the sample needs to be frozen at -20℃ for 1 month.

2. Plasma is recommended to be anticoagulated with heparin or EDTA.?If it cannot be used immediately,?it is recommended to be stored at 2-8℃ to complete the test within 24 hours. If the test cannot be performed within 24 hours, the sample should be frozen at -20℃, valid for 1 month.

3. Whole blood is recommended to be anticoagulated with heparin or EDTA, if it cannot be used immediately it is recommended to be stored at 2-8℃?to complete the test within 24 hours, freezing of whole blood samples is prohibited.

4. Samples containing sediment or flocculent material should be centrifuged (4000rpm, 10min) and then tested.

5. Samples must be returned to room temperature (15-30℃) before testing. Frozen samples should be completely thawed, rewarmed and mixed well before use. Do not repeatedly freeze and thaw.

6. Heat inactivated samples, hemolysis and other abnormal samples should be discarded.

【Test Method】

The test method is homogeneous chemiluminescence?immuoassay

1. Preparation before testing.

1.1 Please read this manual and the instrument manual carefully before use.

1.2 Check whether the instrument can work normally, whether the reaction cup or sample tube, substrate solution and buffer are prepared adequately, and prepare other related consumables.

2. Test procedure

2.1 Turn on the chemiluminescent immunoassay analyzer.

2.2 Check whether the calibration code is consistent with the lot number of the kit and scan the calibration code.

2.3 Mix 50μL of the sample to be tested into the reaction cup, put it into the instrument and start incubation, measurement, data processing and test results.

2.4 The total detection time is 5 minutes.

3.Result analysis.

The measured chemiluminescence intensity is converted from the standard curve to obtain the concentration of PCT in the unknown sample, which can be read at the ng/mL level.

4. Calibration

Each batch of the kit contains its specific calibration information, which is stored on a calibration card.

【Reference Interval】

The following reference ranges were determined by statistical analysis of the 95% confidence interval distribution range of PCT levels in 200 healthy human samples according to normal distribution.

Normal reference value: ≤0.05 ng/mL

Clinical diagnostic threshold (Cut-off value): PCT <0.5 ng/mL predicts low risk of inflammation or local infection

The PCT level measured will vary depending on the region, the individual and the test method used. It is therefore recommended that each laboratory should establish its own range of reference values for its own distinctive population.

【Interpretation of Test Results】

1. The test results are for clinical reference only and should be considered in conjunction with clinical symptoms, medical history, other laboratory tests and other circumstances, and should not be used as the sole basis for clinical diagnosis.

2. The PCT concentration in the first day after trauma, after major surgery, burns, treatment with OKT3 antibody, other drugs stimulating the release of cellular inflammatory mediators, small cell lung cancer, medullary C-cell carcinoma of the thyroid gland; infants within 48 hours of birth; patients with prolonged or severe cardiogenic shock, and patients with prolonged severe organ perfusion abnormalities, etc., will have a higher than normal PCT concentration, but it is not used as the main basis for determining their systemic However, it is not used as the main basis for determining their systemic infection.

3. If the test result is abnormal or differs from the clinical diagnosis, verification is recommended.

4. The operating procedure must be followed strictly and carefully in order to obtain correct results. Any modification to the operating procedures may affect the accuracy of the test results.

5. Bacterial contamination of the sample or repeated freeze-thawing may also affect the results.