Performance Evaluation Report of Guangdong Weishi Bio-new Generation of Hypersensitive Cardiac Troponin I(hs-cTnI)
High Sensitivity Cardiac Troponin I(hs-cTnI) Test Performance Evaluation Report
Wuhan Asian Heart Hospital
Recently, Wuhan Asian Heart Hospital according to the "cardiac troponin laboratory testing and clinical application of Chinese experts consensus" requirementsHypersensitive cardiac troponin I(hs-cTnI) detection kit (immunofluorescence method) of Guangdong Weishi Biotechnology Co., Ltd.A performance evaluation was conducted.
According to the consensus of domestic experts, clinical laboratories should at least verify LoB, LoD, 99th URL and the total CV at nearby concentrations. At the same time, hs-cTn detection method is required to meet the requirement that "free cardiac troponin (cTn) can be stably detected in the peripheral blood of more than 50% healthy men and women" and "the detection result is equal to or higher than the detection limit, at the same time, CV ≤ 10% at the 99th percentile concentration", otherwise it is a common troponin detection method.
The assessment report states that Guangdong Vesco Biotechnology Co.Hypersensitive cardiac troponin I(hs-cTnI) detection kit (immunofluorescence method)Precision, accuracy, detection rate and other indicatorsAll of them met the definition of high-sensitivity cardiac troponin I in Chinese Expert Consensus on Laboratory Detection and Clinical Application of Cardiac Troponin.
The results of the assessment are summarized as follows:
1. Repeated inprecision and intermediate inprecision CV tests were carried out for three clinical samples of low, medium and high concentrations of 0.035ng/ml, 0.524ng/ml and 2.222ng/ml,The results were 9.36-8.19%, 6.31-6.62%, 5.33-8.72%, respectively. The requirements stated in the manufacturer's instructions are met.
2. Collect the same patient's serum, plasma (heparin lithium anticoagulation and EDTA anticoagulation) and whole blood (heparin lithium anticoagulation and EDTA anticoagulation) samples, a total of 50 groups, respectively, to detect hs-cTnI.The results showed that heparin/EDTA plasma and whole blood, serum samples of high-sensitivity troponin I have good correlation.
3. Select 172 cases of heparin plasma detected by Beckman hs-cTnI, the concentration level is from low value to about 141 ng/ml, and use the hs-cTnI detection system of Guangdong Weishi Biotechnology Co., Ltd. to detect and compare, and draw a scatter diagram (see Figure 2),The statistical regression equation was y = 1.0203x 0.6277,R2 = 0.9441, and the consistency of clinical positive and negative judgment was good.
Fig. 2 Correlation analysis of hs-cTnI-Beckman hs-cTnI of Guangdong Weishi Biotechnology Co., Ltd.
4. Select a sample close to the upper limit of the linear range hs-cTnI concentration level declared by the manufacturer of Guangdong Weishi Biotechnology Co., Ltd. and a sample at the low concentration level near the detection limit for high and low gradient dilution. The regression equation for linear range validation was y = 1.0099x +0.7384,R2=0.9977.The prediction value is well correlated with the detection mean, and the detection data range meets the linear requirements, which is consistent with the linear range stated in the manual.
Figure 3 Scatter plot of the measured and expected values of the hs-cTnI of Guangdong Weishi Biotechnology Co.
5 the blank limit (LoB) was 0.010 ng/ml, and the detection limit (LoD) was 0.013ng/ml.
6. Total Imprecision (CV%)10% corresponds to a hs-cTnI concentration (LoQ) of 0.040 ng/ml, and the CV% at the 99th percentile concentration level is 7.50.
Fig. 4 Determination of 10% total unprecision of hs-cTnI detection
7. A total of 656 cases of surface healthy people were included in the hs-cTnI test, and 524 cases of normal people were detected, accounting for 79.9 per cent of normal people.
8. The maximum dilution factor is 20 times.
Conclusion and discussion:
Paying attention to product quality, technological innovation and improving detection performance are the core values of Guangdong Weishi biological immunofluorescence products. The project performance evaluation results of Wuhan Asian Heart Hospital show that its precision index meets the requirements. The product has a high consistency with the Beckman test results of the control system. The detection rate of troponin in normal population was as high as 79.9%. These data are summarized as follows:Using the Guangdong Weishi Bio-hypersensitive cardiac troponin I(hs-cTnI) detection kit, precise and accurate detection results can be obtained.