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

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

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

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)