CTS serology panels are used to meet the requirements of the new European Regulation 2017/746 on in-vitro-diagnostics. This regulation replaces the previous Directive 98/79/EC and will need to be implemented by May 26, 2022.
You can find more information about the IVDR here.
If you have any further questions about the new IVDR, or if you need assistance with re-sampling or with the implementation of legally compliant documentation, please contact us.
Diagnostic Sensitivity Panels
Order. no. Panel
Panels for screening tests (acc. to Table 1, CTS):
Anti-HIV 1/2 panel
400 Anti-HIV 1 positive samples with
30 HIV seroconversion panels
All seroconversion samples include established positives (they are p24 antigen and/or HIV RNA positive, established/detected by antibody screening (verification) tests and determined to be positive or undetermined by means of confirmatory tests),
400 Anti-HCV positive samples with
30 HCV seroconversion panels
400 HBsAg positive samples with the different subtypes A1, A2, B1, B2, C1, C2, D1-7, E, F1-4, G, H
30 HBV seroconversion panels
Diagnostic Specificity Panels
Blood donor panels
5000 (screening test) or 1000 (rapid test) samples from unselected blood donors from at least 2 different European donation centers
Hospitalized patient panels
200 samples from patients suffering from severe illness and on medication
General test panels
RF +, HAMA, pregnant women, multipara, hyper-IgM, hyper-IgG, dialysis patients, influenza vaccinated individuals, etc.
Blood bank marker panels
Anti-HIV 1, Anti-HCV, HBsAg, Anti-Syphilis etc.
Anti-HSV 1, Anti-HSV 2, Anti-VZV, Anti-EBV, Anti-CMV
Anti-HAV, Anti-HBs, Anti-HBc, Anti-HEV
Hemolytic, lipemic and icteric samples, low, mid and high concentration in addition to a negative control
Serum / plasma equivalence panels
25 negative matched sets
Serum, plasma (including all anticoagulants that might be used)