We compared a third-generation quantitative cardiac troponin T (cTnT) test (POCT) from Roche Diagnostics with the laboratory assay (Roche Elecsys 2010 immunoassay analyzer). Heparin-treated blood and serum were collected simultaneously from 133 unselected patients (mean age 62 +/- 14 years, 38% women) who presented to our hospital with suspected cardiac chest pain. The results of the POCT were compared with the laboratory test considered as the gold standard. There were 18 POCT positive patients versus 24 laboratory test positive (> or = 0.03 ng/mL) patients.
POCT was falsely negative in six patients, with values between 0.03 and 0.1 ng/mL. POCT had a sensitivity of 75%, a specificity of 100%, a positive predictive value of 100%, a negative predictive value of 95%, and an overall accuracy of 95%; kappa = 0.831 (P < 0.001). There was a good correlation between the POCT values and the laboratory test: Y = 1.195X + 0.002, r2 = 0.94 (P < 0.0001). While cTnT levels > 0.1 mg/mL were reliably detected with this current generation of POCT, cTnT levels between 0.03 and 0.10 ng/mL were not. Future generations of devices should improve sensitivity to reliably stratify the risk of patients with suspected acute coronary syndromes.
Multiplexed detection Differential pulse voltammetryCd2+Pb2+Cu2+Hg2+
1. Infection: hsCRP+CRP, PCT
2. Cardiac markers: NT-proBNP, CK-MB, cTnI, Myo, 2 in 1 (CK-MB/cTnI), 3 in 1 (CK-MB/cTnI/Myo)
3. Diabetes: HbA1c
4. Coagulation: D-dimer
Advantages of our YSTE-FIA12 test platform
- Support 12 multi tests at the same time
- Twelve test channels, with an actual speed measurement of 120T
- Scan and identify the test items as well as the test strips that come out automatically after finishing the test.
- Multiple test items, make medical examination efficient and fast.
- Data can be uploaded to LIS and automatically printed
SARS-CoV-2-specific antibodies will bind to purified recombinant HEK cell-derived receptor-binding domain (RBD) of SARS-CoV-2 spike protein coated on the microtiter plate. After appropriate washing steps, horseradish peroxidase-labelled polyclonal anti-human IgG secondary antibody binds to the captured protein. The excess secondary antibody is washed away and the TMB substrate is used for colour development at 450nm. Samples that exceed a certain cutoff value are designated as positive in this assay.
Detection Target: IgG isotype SARS-CoV-2 specific antibodies
Sample Dilution: A 1:51 dilution of serum samples is suggested for best results.
Expected Values: Significant seroconversion, as evidenced by antibodies specific for both the full-length SARS-CoV-2 spike protein and the RBD region, has been detected as early as two days after symptom onset.
Sensitivity: 97% for samples obtained more than 14 days after symptom onset (n=37), 100% for samples obtained more than 21 days after symptom onset (n=32).
Specificity: 100% (n=89)
Agreement Percentage: Positive 100%; negative 91%
Storage: Store all kit components at 4°C upon arrival. Return unused microplate strips to the plate bag with desiccant. Reconstituted controls can be stored at -80°C for later use. Store all other unused kit components at 4°C. This kit should not be used beyond the expiration date.
Negative results do not exclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary. Antibody test results should not be used to diagnose or exclude acute SARS-CoV-2 infection. Positive results may be due to past or present infection with coronavirus strains other than SARS-CoV-2, such as KHU1, NL63, OC43, or 229E.
This serological assay can be used for applications such as the characterization of immune responses to viral infections by determining the presence of antigen-specific viral antibodies in sera from infected and recovered patients. At Innovative Research, we provide reliable and consistent products that deliver reliable and consistent results.