CTS Serology Panels
The CTS panels serve to fulfil the requirements specified in the new European IVDR Directive 2017/746 on common technical specifications for in vitro diagnostics. This Directive replaces previous Directive 98/79/EG and must be transposed by 26 May 2022. If you have any further questions about the new IVDR or need support in re-sampling or in implementing legally compliant documentation, please contact us. Further information on the IVDR can be found here.
Diagnostic Sensitivity Panels
Cat. No. Panel | Product Description | ||
Panels for Screening Tests (according to table 1 CTS) | |||
CTS-HIV | Anti-HIV 1/2 | 400 Anti-HIV 1 positive samples including | |
30 HIV | All Seroconversion samples are identified as positive (p24 antigen and/or HIV RNA positive, recognised by all of the antibody screening tests and positive or indeterminate with confirmatory assays) including at least 40 early Seroconversion HIV samples (p24 antigen and/or HIV RNA positive, not recognised by all of the antibody screening tests and indeterminate or negative with confirmatory assays) | ||
CTS-HCV | Anti-HCV | 400 Anti-HCV positive samples including | |
30 HCV Sero- | |||
CTS-HBsAg | HBsAg Panel | 400 HBsAg positive samples including the different Subtypes A1, A2, B1, B2, C1, C2, D1-7, E, F1-4, G, H | |
30 HBV Sero- |
Diagnostic Specificity Panels
Cat. No. | Panel | Product Description | |
CTS-BDP | Blood Donor Panel | 5000 (screening test) or 1000 (rapid test) samples of not selected blood donors (from at least 2 different European donor centers) | |
CTS-HPP | Hospitalized Patient Panel | 200 samples of hospitalized patients which suffer from severe underlying diseases and have to take medication | |
Interference Panels | |||
Basic Test | (RF+, HAMA, pregnant women, multipara, Hyper IgM, Hyper IgG, Dialysis patients, Influenca vaccine recipient, etc.) | ||
Blood Bank | Anti-HIV 1, Anti-HCV, HBsAg, Anti-Syphilis etc.) | ||
Herpes Panel | (Anti-HSV 1, Anti-HSV 2, Anti-VZV, Anti-EBV, Anti-CMV) | ||
Hepatitis Panel | (Anti-HAV, Anti-HBs, Anti-HBc, Anti-HEV) | ||
Inhibition Panel | (Haemolytic, lipaemic and icteric samples, low, med and high concentration as well as negative control) | ||
Serum/Plasma Equivalency Panels | |||
25 negative | Serum, plasma (incl. all anticoagulants which are indicated for use) | ||
25 positive | Serum, plasma (incl. all anticoagulants which are indicated for use) |