CE approved PCT Test Kit for Procalcitonin Qualitative Detection in hospital clinical laboratory

High sensitivity cFDA approved PCT Quantitative Detection Kit (TRFIA)

Test Kit Components

Test Principle

The PCT Test Kit is a time-resolved fluorescence immunochromatographic technique for quantitative determination of the procalcitonin (PCT) concentration in blood samples. The sample buffer and blood sample are mixed and added to the test card. The sample PCT coupled with the fluorescent microspheres on the marker pad PCT monoclonal antibody to form a complex. The detection band containing another specific antibody on the nitric acid fiber membrane PCT capillary action chromatography was captured to form a double antibody sandwich complex. As a result, the more PCT in the blood sample, the more complex the detection band accumulates. The excess unreacted fluorescent microspheres continued to be chromatographic to the control line. After the reagent strip is excited, the fluorescence intensity on the detection line reflects the content of the captured PCT in the sample. 

Intended Use

This procalcitonin detection kit is suitable for quantitative detection of procalcitonin (PCT) in human serum/ plasma/ whole blood in vitro. PCT is a very sensitive and specific blood sample marker, and its concentration is positively correlated with the severity of inflammation. Therefore, it can be used as a reliable indicator to judge the condition and prognosis and observe the curative effect. At present, PCT detection is mainly used in the diagnosis and differential diagnosis of bacterial infection, viral infection, fungal infection, and sepsis.

Compatible Equipment

Lumigenex Time-resolved Fluorescence Immunoanalyzer LTRIC-600, LTRIC-1000

Performance

• ​Accuracy: Deviation from the quality control target value should be within ±15%.
• Minimum detection limit: no higher than 0.1ug/mL.
• Linearity : (0.2-50) ug/mL, the kit correlation coefficient R≥0.9900.
• Repeatability: Coefficient of variation (CV) ≤15%.
• Inter-batch difference: Inter-batch variation coefficient (CV) ≤15%.

Storage

The reagent card in the kit is stored in the sealed state of the aluminum foil bag at 2℃~8℃ , valid for 18 months; If the effective date printed on the aluminum foil bag package is not exceeded, the reagent card sealed in the aluminum foil bag package can be stored stably at temperature (2℃~30℃) for 30 days. The temperature change during transportation (<37℃) has no effect on product quality. Aluminum foil bag after unsealing reagent card, product stability time is 1 hour.

Certificate: CE

Shipping Package

Company Profile

Lumigenex (Suzhou) Co., Ltd. is a biotechnology company dedicated to the development of proprietary technologies that meet the ever-increasing demands of clinical diagnostics. Lumigenex is focused on developing cost-effective rapid diagnostic products based on our patented Time-Resolved Fluorescence Immunoassay (TRFIA) platform with primary areas of interest in cardiology, women's health, infectious disease, oncology, and drugs of abuse. Closely collaborating with our global strategic partners, Lumigenex is committed to becoming a worldwide leader in the fields of quantitative POCT.