Best. Nr.           

Produktbeschreibung

 Panel für Screeningtests (gemäß Tabelle 1, CTS):

CTS-HIV

Anti-HIV 1/2
Panel

400 Anti-HIV 1 positive Proben mit
  • 40 nicht-B-Subtypen (je min. 3 Proben der Subtypen A, C, D, F, G, H, J, K, CRF01_AE,
    CRF02_AG, CRF06_cpx3, CRF11_cpx und Gruppe O)
  • 3 Subtypen B
  • 357 Anti-HIV 1 Proben nicht spezifiziert
100 Anti-HIV 2 Proben

30 HIV Serokonversionspanel

Alle Serokonversion Proben wurden als positiv erkannt (sie sind p24 Antigen und/oder HIV RNA positiv, anerkannt/detektiert durch Antikörper Screening (Überprüfungs-) Tests und als positiv oder unbestimmt mittels Bestätigungstests festgelegt), inklusive mind. 40 früher HIV Seroconversionsproben (diese sind p24 Antigen und/oder HIV RNA positiv, nicht anerkannt/bestimmt durch Antikörper Screening Tests und als unbestimmt oder negativ mittels Bestätigungstests festgelegt)

CTS-HCV

Anti-HCV
Panel

400 Anti-HCV positive Proben mit
  • 21 vom Genotyp 1
  • 21 vom Genotyp 2
  • 21 vom Genotyp 3
  • 21 vom Genotyp 4
  • 21 vom Genotyp 4 nicht Subtype A
  • 5 vom Genotype 5
  • 280 HCV Proben nicht spezifiziert

30 HCV Serokonversionspanel

CTS-HBsAg

HBsAg 
Panel

400 HBsAg positive Proben mit den unterschiedlichen Subtypen A1, A2, B1, B2, C1, C2, D1-7, E, F1-4, G, H

30 HBV Serokonversionspanel

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

Best. Nr.

 Panel

Produktbeschreibung

CTS-BDP

Blutspender Panel

5000 (Screeningtest) oder 1000 (Schnelltest) Proben nicht ausgewählter Blutspender von mindestens 2 verschiedenen europäischen Spendezentren

CTS-HPP

Krankenhauspatienten Panel

200 Proben von Patienten, die an schweren Erkrankungen leiden und unter Medikation stehen

Kreuzreaktionspanel
Mehr als 100 Proben, die interagierende Substanzen enthalten, wie etwa RF+, Autoimmune Antikörper, EBV, CMV,
Hepatitis Proben, etc.

Allgemeines Test
Panel

RF+, HAMA, schwangere Frauen, multipara, Hyper IgM, Hyper IgG, Dialysepatienten, Influenza geimpfte Person, etc.
30 Proben (jeweils 3 Proben)

Blutbank Marker
Panel

Anti-HIV 1, Anti-HCV, HBsAg, Anti-Syphilis etc.
15 Proben (jeweils 3 Proben)

Herpes
Panel

Anti-HSV 1, Anti-HSV 2, Anti-VZV, Anti-EBV, Anti-CMV
15 Proben (jeweils 3 Proben)

Hepatitis
Panel

Anti-HAV, Anti-HBs, Anti-HBc, Anti-HEV
12 Proben (jeweils 3 Proben)

Inhibition
Panel

Hämolytische, lipämische und ikterische Proben, low, med und high Konzentration neben negativer Kontrolle
36 Proben (jeweils 3 Proben)

 25 negative
 Matched Sets

Serum, Plasma (inkl. aller Antikoagulantien, die verwendet werden können)

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)