CTS Serology Panels

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		Product description
Panels for screening tests (acc. to Table 1, CTS):
CTS-HIV	Anti-HIV 1/2 panel	400 Anti-HIV 1 positive samples with • 40 non-B-subtypes (in each case at least 3 samples of the subtypes A, C, D, F, G, H, J, K, CRF01_AE, CRF02_AG, CRF06_cpx3, CRF11_cpx and group O) • 3 subtypes B • 357 Anti-HIV 1 samples unspecified 100 Anti-HIV 2 samples
CTS-HIV	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), and include at least 40 early HIV seroconversion samples (these are p24 antigen and/or HIV RNA positive, not established/determined by antibody screening tests and determined as undetermined or negative using confirmatory tests)
CTS-HCV	Anti-HCV panel	400 Anti-HCV positive samples with • 21 of genotype 1 • 21 of genotype 2 • 21 of genotype 3 • 21 of genotype 4 • 21 of genotype 4 not subtype A • 5 of genotype 5 • 280 HCV samples unspecified
CTS-HCV	30 HCV seroconversion panels
CTS-HBsAg	HBsAg Panel	400 HBsAg positive samples with the different subtypes A1, A2, B1, B2, C1, C2, D1-7, E, F1-4, G, H
CTS-HBsAg	30 HBV seroconversion panels

Diagnostic Specificity Panels

Order no.	Panels	Product description
CTS-BDP	Blood donor panels	5000 (screening test) or 1000 (rapid test) samples from unselected blood donors from at least 2 different European donation centers
CTS-HPP	Hospitalized patient panels	200 samples from patients suffering from severe illness and on medication
Cross-reaction panels More than 100 samples containing cross-reacting substances such as RF +, autoimmune antibodies, EBV, CMV, hepatitis samples, etc.
	General test panels	RF +, HAMA, pregnant women, multipara, hyper-IgM, hyper-IgG, dialysis patients, influenza vaccinated individuals, etc. 30 samples (in each case 3 samples)
	Blood bank marker panels	Anti-HIV 1, Anti-HCV, HBsAg, Anti-Syphilis etc. 15 samples (in each case 3 samples)
	Herpes panels	Anti-HSV 1, Anti-HSV 2, Anti-VZV, Anti-EBV, Anti-CMV 15 samples (in each case 3 samples)
	Hepatitis panels	Anti-HAV, Anti-HBs, Anti-HBc, Anti-HEV 12 samples (in each case 3 samples)
	Inhibition panels	Hemolytic, lipemic and icteric samples, low, mid and high concentration in addition to a negative control 36 samples (in each case 3 samples)
Serum / plasma equivalence panels In the case of products intended by the manufacturer for testing serum and plasma, the serum-plasma equivalence must be confirmed in the performance evaluation. Evidence must be provided from at least 50 donations (25 positive and 25 negative).
	25 negative matched sets	Serum, plasma (including all anticoagulants that might be used)