Description
expected usage
This test kit is used for clinical in vitro quantitative detection of procalcitonin (PCT) content in human serum, plasma, whole blood or peripheral blood. The content of procalcitonin in the blood of healthy people is very low (<0.1ng/mL), and the secretion increases when the body is stimulated by pro-inflammatory response, especially when stimulated by bacterial infection. Clinical studies have proved that procalcitonin does not increase or only slightly increases in viral infections, local or mild bacterial infections, while a significant increase in procalcitonin can be seen in the early stages of severe bacterial infections (such as sepsis). After antibiotic treatment to control the infection, the level of procalcitonin in the blood will quickly drop to a normal level. Therefore, procalcitonin can be used as an important diagnostic and monitoring indicator for severe systemic infections or sepsis; it can assist the clinic in quickly identifying bacterial infections or viral infections, and judge the severity of bacterial infections; it can guide the clinical rational use of antibiotics , To reduce the patient’s exposure to antibiotics, reduce the rate of adverse reactions and the production of drug-resistant bacteria. Currently, clinical and laboratory methods for detecting procalcitonin are immunoturbidimetric method, enzyme-linked immunoassay, colloidal gold method, immunofluorescence method, chemiluminescence method, time-resolved fluorescence immunochromatography and so on.
Inspection principle
Principle of the kit: Two highly specific and highly sensitive PCT monoclonal antibodies and one PCT polyclonal antibody. PCT monoclonal antibody I is a fluorescently labeled antibody, which is pre-coated on a fluorescent pad, PCT polyclonal antibody and PCT Monoclonal antibody II is a capture antibody, which is coated on the detection area of the chromatographic membrane. The quality control area is coated with rabbit anti-mouse IgG antibody. The antigen-antibody reaction and fluorescence immunochromatography technology are used to quantitatively detect the content of PCT in human blood.
The working principle of the supporting instrument: The measuring system of the instrument automatically scans the binding area of the label and the test substance on the test card after the reaction, and obtains the optical signal. Then the optical signal is measured and analyzed, and the concentration of the measured substance can be obtained quantitatively.
Specification：25T
Kit composition
Procalcitonin detection card (dry immunofluorescence method)
Instructions: 1 copy/box
SD card
Buffer
straw
Storage conditions and expiry date
The test card is stored in a sealed state at 4~30C, and the validity period is 18 months.
Sample requirements
- For human serum, plasma, whole blood or peripheral blood samples, other body fluids and samples may not get accurate results.
- The venous blood should be collected under aseptic conditions. It is recommended to use human serum or plasma for testing.
- Peripheral blood collection: Use a peripheral blood collection device to apply blood on the pre-sterilized blood part (the middle finger and ring finger are preferred).
Let the blood flow out naturally, wipe off the first drop of blood with sterile cotton, use a peripheral blood collection tube (EDTA anticoagulation) to sample and collect about 0.2mL,
And mix upside down or flick to mix well to prevent solidification.
- Plasma and whole blood samples can be anticoagulated with heparin or sodium citrate. EDTA is not recommended as an anticoagulant.
- Peripheral blood samples can use EDTA anticoagulant.
- After clinical blood samples are collected, the test must be completed within 4 hours at room temperature; serum and plasma can be stored at 2~8°C for 5 days; 2 (stored below TC, can be stored for 6 Months. Whole blood and peripheral blood samples should not be frozen, stored at 2~8C, and can be stored for 3 days. Avoid heating inactivated samples, and hemolyzed samples should be discarded.
- The sample must be returned to room temperature before testing. The frozen samples must be completely thawed, rewarmed, and evenly mixed before use. Avoid repeated freezing and thawing. It is recommended that the sample be frozen and thawed no more than once.
Testing method
Before using this reagent, you must read the instructions of the reagents carefully and strictly follow the instructions of the reagents to prove reliable results.
- Preparation
Return the test card, sample, and buffer to room temperature (15-30°C) before testing. It is recommended to unpack the test card after returning to room temperature, and use it as soon as possible within the validity period to prevent the test card from getting wet.
- Calibration
Confirm that the batch number of the SD card matches the test card, perform SD card calibration, and calibrate the instrument parameters.
- Add samples
①According to the type of sample, select the sample mode on the analyzer: “serum/plasma” mode or “whole blood” mode.
Serum and plasma: draw 100ul serum or plasma sample, drop it vertically to the sample point of the test card, and start timing.
Peripheral blood/whole blood: draw 100ul peripheral blood/whole blood sample, drop it vertically to the sample point of the test card, immediately add a drop of whole blood buffer (20ul~30ul) to the sample point, and start timing.
Peripheral blood: adopt the “whole blood” mode.
② After 15 minutes, insert the test card into the carrier of the fluorescence immunoassay quantitative analyzer, press the “Measure” button, the instrument will automatically detect and print the results.
Positive judgment value or reference interval
The statistical analysis of 500 healthy people showed that the upper limit of the reference interval is 0.1ng/ml at the 99th percentile.
A study of ICU patients showed that:
PCT <0.5ng/ml indicates a low risk of severe sepsis and/or septic shock
PCT>2ng/ml indicates a high risk of severe sepsis and/or septic shock
The reference intervals for plasma, whole blood, and peripheral blood samples are consistent with the reference intervals for serum samples.
Each laboratory shall determine the applicability of the reference interval through experiments, and establish the reference interval of the laboratory when necessary.
Interpretation of test results
Use a fluorescence immunoquantitative analyzer to analyze the reaction card and issue a quantitative test result.
The detection range of this kit is 0.05ng/ml-50.0ng/ml. When the sample concentration exceeds the upper limit of detection, calf serum or negative samples should be used to dilute high-concentration samples, and the maximum dilution factor is 5 times.
The hemoglobin, triglycerides and bilirubin in the sample will interfere with the test results, and the maximum allowable concentrations are 5g/L, 10g/L and 0.2g/L, respectively.
Product performance
- The minimum detection limit should not be higher than 0.05ng/ml.
- Linear range: within the interval of 0.05ng/mL~50.0ng/mL, the linear correlation coefficient r>0.990.
- Accuracy: the relative deviation is not more than 20%.
- Repeatability should not be greater than I0%.
- Inter-assay precision (inter-assay difference) should not be greater than 15%.
Limitations of the test method
- This kit is limited to in vitro diagnostic use only.
- The test results of this kit are for clinical reference only, and cannot be used alone as a basis for confirming or excluding cases. In order to achieve diagnostic purposes, the test results should be used in conjunction with clinical examination, medical history and other examination results.
Precautions
- The straws cannot be mixed to avoid cross-contamination.
- The procalcitonin detection kit (dry immunofluorescence method) can be traced to the Roche automatic chemiluminescence immunoassay instrument and the supporting procalcitonin detection kit (electrochemiluminescence method).
- If you need to contact the manufacturer to provide the Procalcitonin detection kit (dry immunofluorescence method) “Metrical Traceability Report”.
- After the test card is unpacked, the test should be carried out as soon as possible to avoid leaving it in the air for too long, which may cause moisture.
- The test card can be sealed and stored at room temperature. Beware of moisture. The test card stored at low temperature should be equilibrated to room temperature before use.
- This product contains sodium azide as an antiseptic. Sodium azide can react with copper or lead pipes in drainage pipes and produce explosives. Please dispose of them properly in accordance with local regulations.
- For those substances that contain the source of infection or suspected of containing the source of infection, there should be appropriate biosafety assurance procedures. The following are relevant precautions:
☆Wear gloves to handle samples or disinfect reagents.
☆ Use disinfectant to disinfect the spilled samples or reagents.
☆Disinfect and dispose of all specimens, reagents and potential contaminants in accordance with relevant local regulations.
