Singclean Procalcitonin (PCT) Test Kit (Fluorescence Immunochromatography) for infection detection
Introduction
Procalcitonin (PCT) is the prohormone of calcitonin (CT), which is generally less than 0.1ng/mL in the blood of healthy people, and its secretion increases after being stimulated by pro-inflammatory responses, especially after bacterial infection. Procalcitonin is an important marker that can specifically distinguish bacterial infection from inflammatory response caused by other reasons. Viral infection, allergy, autoimmune disease and transplant rejection do not cause significant elevation of procalcitonin, while local bacterial infection can result in moderate elevation of procalcitonin concentrations. In some cases (neonatal, multiple trauma, burns, major surgery, prolonged or severe cardiogenic shock), the elevation of procalcitonin may not be related to infection and usually returns to normal values quickly.
PCT is an ideal indicator for the auxiliary diagnosis of severe bacterial infection and septicopyemia, sepsis and other diseases, and has high sensitivity and specificity for systemic bacterial infection, septicopyemia, sepsis, etc.
Indications for Use
The test kit is used for the quantitative determination of procalcitonin (PCT) in human serum, plasma or whole blood samples in vitro.
Who Should Have the Procalcitonin (PCT) Test?
Vulnerable groups are infants and newborns, the elderly, patients with a history of serious diseases such as severe infection and severe burns, patients with impaired immune system, and tumor patients. Symptoms are like recurrent chills, high fever, petechiae rash, arthralgia of large joints, hepatomegaly. These people are suggested to have a Procalcitonin (PCT) Test.
Singclean Advantages
Accurate: the fluorescence immunochromatography method based test kit has higher accuracy.
Easier to read: based on fluorescence immunochromatography, easier to read test result than colloidal gold immunochromatography.
Easy for storage: it can be stored at room temperature (4ºC~30ºC).
Longer validity period: 18 months of validity period.
Product Performance Index
a) Accuracy: The recovery rate is between 85% and 115%.
b) Linear range: within the linear range of 0.1ng/mL ~100ng/mL, the linear correlation coefficient r≥0.9900;
c) Blank limit: not higher than 0.05ng/mL;
d) Precision
In-batch precision: The coefficient of variation (CV) is not more than 15%;
Precision between batches: The relative range between batches is not more than 15%.
Product Information
| Product Name |
Procalcitonin (PCT) Test Kit |
| Method |
Fluorescence immunochromatography |
| Specimen |
Whole blood, Plasma, Serum |
| Specification |
10 tests/box, 20 tests/box, 25 tests/box, 30 tests/box, 50 tests/box, 100 tests/box. |
| Components |
Each bag contains a test card and a desiccant; the test card is composed of a t shell and a test strip, and the test strip consists of a sample pad, a fluorescent pad (fixed with fluorescently labeled PCT monoclonal antibody 1), nitrocellulose membrane (coated with PCT monoclonal antibody 2 and goat anti-mouse IgG), filter paper and PVC plastic plate |
| Test time |
10 mins |
[Applicable instrument]
Fluorescence immunoassay analyzer
It should be purchased separately and can be used for different Test Items, like CK-MB, IL6, PCT.
For different tests, scan the QR code accordingly.
Specimen Collection
1. Human serum, plasma or whole blood samples; other body fluids and samples may not give accurate results.
2. Venous blood or fingertip blood should be collected under sterile conditions. It is recommended to use human serum or plasma for testing.
3. Anticoagulation with EDTA, sodium citrate or heparin is recommended for plasma and whole blood samples.
4. After the 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 3 days and stored below -20°C for 5 months. Whole blood samples should not be frozen and stored at 2~8°C for 3 days. Avoid heat inactivating samples, and hemolyzed samples should be discarded.
5. Samples must be returned to room temperature before testing. Cryopreserved samples need to be completely thawed, rewarmed, and evenly mixed before use. Do not freeze and thaw repeatedly.
Test Procedure:
a) Bring the test kit and sample to be tested to room temperature.
b) Make sure the ID card matches the batch number of the kit, and insert the ID card into the card reading area of the instrument to read the information.
c) Open the inner package of the test card, take out the test card; draw 70μL of serum plasma sample, drop vertically to the test card sampling place, and start timing; draw 70μL whole blood, vertically drop it to the test card sampling place, and immediately add 1 drop whole blood diluent at the sample adding place and start timing.
d) After adding the sample, click "Start Test" on the screen of the fluorescence immunoanalyzer, and the test card will react at room temperature for 10 minutes; insert the test card into the test card slot of the fluorescence immunoanalyzer, and the instrument will automatically test the test card; The test results can be seen on the display screen of the immunoassay analyzer. Click "Print" on the screen to print the results.
Positive Judgment Value or Reference Interval
Reference value: <0.5ng/mL. The reference interval for plasma and whole blood samples is the same as that for serum samples. Due to differences in geography, race, gender and age, it is recommended that each laboratory establish its own positive judgment value or reference interval.
Interpretation of Results
(For reference only, not used as clinical diagnostic criteria, test results need to be combined with other clinical and laboratory data for clinical diagnosis)
| PCT mass concentration (ng/mL) |
Clinical significance |
| <0.05 |
Normal value |
| <0.5 |
No or mild systemic inflammatory response. May be local inflammation or local infection. |
| 0.5-2 |
Moderate systemic inflammatory response. Infection may be present. |
| 2-10 |
Most likely sepsis, severe sepsis, or septic shock. There is a high risk of organ dysfunction. |
| ≥10 |
Almost all severe bacterial sepsis or septic shock. Often accompanied by organ failure, there is a high risk of death. |
Limitation
a) This kit is only for the test of human serum, plasma or whole blood samples. Abnormal hematocrit samples have an impact on the results of the whole blood test. The test results of serum, plasma and whole blood are not significant difference when the hematocrit is between 21% and 48%.
b) The test results need to be combined with other clinical and laboratory data, and if the PCT test results do not match the clinical assessment, further testing is required.
c) False positive results may be caused by: cross-reaction of antibody-like components in the blood; some nonspecific components in blood have similar antigenic determinants to capture fluorescent-labeled antibodies.
d) Hemoglobin, triglycerides and bilirubin in the blood sample can interfere with the test results, where the maximum allowable concentrations are 5g/L, 10g/L and 0.2g/L, respectively.
e) False negative results may be caused by: some unknown components shield the antigenic determinants from binding to the antibody; the unstable PCT antigen gradually degrades with time and temperature and cannot be recognized by the antibody. Valid test results depend on a good reagent and sample storage environment.
f) Other factors may also cause errors in test results, including technical reasons, operational errors and other sample factors.
12. Certificate
CE ISO13485
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