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
 Panel

400 Anti-HIV 1 positive samples including
• 40 non-B-Subtypes (at least 3 samples each 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 not specified
100 Anti-HIV 2 samples

 30 HIV
 Seroconversion Panels

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
 Panel

400 Anti-HCV positive samples including
• 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 not specified

 30 HCV Sero-
 conversion Panels

 

 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-
 conversion Panels

 

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
 100 samples containing interfering substances such as RF+, autoimmune antibodies, EBV, CMV, samples of
 patients suffering from hepatitis etc.

 

 Basic Test
 Panel

(RF+, HAMA, pregnant women, multipara, Hyper IgM, Hyper IgG, Dialysis patients, Influenca vaccine recipient, etc.)
For example 30 samples (3 samples each)

 

 Blood Bank
 Marker Panel

Anti-HIV 1, Anti-HCV, HBsAg, Anti-Syphilis etc.)
For example 15 samples (3 samples each)

 

 Herpes Panel

(Anti-HSV 1, Anti-HSV 2, Anti-VZV, Anti-EBV, Anti-CMV)
For example 15 samples (3 samples each)

 

 Hepatitis Panel

(Anti-HAV, Anti-HBs, Anti-HBc, Anti-HEV)
For example 12 samples (3 samples each)

 

 Inhibition Panel

(Haemolytic, lipaemic and icteric samples, low, med and high concentration as well as negative control)
For example 36 samples (3 samples each)

 Serum/Plasma Equivalency Panels
 Verify the performance using all anticoagulants which are indicated for use
 with 25 negative and 25 positive matched sets.

 

 25 negative
 matched sets

Serum, plasma (incl. all anticoagulants which are indicated for use)

 

 25 positive
 matched sets

Serum, plasma (incl. all anticoagulants which are indicated for use)