Download Circular of Information CBS to Begin using HCV RNA and HIV

m
CANADIAN
BLDOD
SOCiETE
CANADIENNE
CBS to Begin
using
SERVICES
DU SANG
Circular
of Information
HCV RNA and HIV-1 RNA
Customer
Letter
Licensed
Test
Kits
#2004-03
2004-05-17
Dear Customer:
This notice is to advise you that the Canadian Blood Services (CBS) Circular of
Information currently lists all Nucleic Acid Testing (NAT) as unlicensed, however CBS
will begin using the FDA and Health Canada licensed HCV and HIV-1 RNA test kits in
the mid-May 2004 timeframe.
The Circular
of Information
(version
11/02) section
A.2. and A.5 respectively
state:
"Donor samples are also tested for the presence ofHepatitis C Virus (HCV) RNA and Human
Immunodeficiency Virus (HIV-l) and West Nile Virus (WNV) RNA. Currently, Nucleic Acid
Testing (NA T) is an unlicensed test and performed, with permission from Health Canada, for
investigational purposes. All donor testing is performed using methods and reagents authorized
by Health Canada."
"Note: Currently, Nucleic Acid Testing (NAT) is an unlicensed test and is perfonned, with
pennission from Health Canada, for investigational purposes. All donor testing is perfonned using
methods and reagents authorized by
Health Canada."
The Circular
of Information
will be revised
as follows:
A.2 Testing of Donor Blood
Section A.2, page 5, paragraph I and 2 shall read as follows:
Prior to making blood components available for transfusion, a sample of each donor's blood is tested.
Regardless of donation type -Allogenic (homologous), Directed, or Autologous -samples are tested for
the following:
.Antibodies
to Human Immunodeficiency Virus (HIV-I and HIV-2), Hepatitis C Virus (HCV), and
Human T-cell Lymphotropic Virus, Type I and II (HTLV-I/II),
.the
presence ofHepatitis B Surface antigen (HBsAg)
.Syphilis,
.ABO
and Rh typing, and
.Unexpected
antibodies against red cell antigens other than ABO.
Donor samples are also testedfor~e
TestIng (NA T) IS an uriQcens~gte~tandIs performed;wIthpermISSI0np'o~H~alth
Canada,fQr
investi&ationalpurposes. Alldbnbttestingis
performed using methods andreggent§authorizedby
Cana" d a .
Health
(j
HeadOffice/ Siegesocial,1800AltaVista,Ottawa,ON K1G4J5 Tel.!Tel.: (613)739-2300 Fax!Telec.
: (613)731-1411
www.bloodservices.ca
.www.servicessanguins.ca
Charitable
Number:
870157641
RROO01/N°
d'organisation
debienfaisance
: 870157641
RROO01
Canadian
Blood Services
-2-
2004-05-17
A.5 Side Effects and Hazards of Blood and Blood Components
Section A.5, page 9, paragraph 1 shall read as follows:
I. Infectious diseases may be transmitted in spite of careful selection of donors and testing of blood.
Donor selection criteria are designed to screen out individuals who are at an increased risk for HIV ,
HTL V, and hepatitis infection. Each donor sample is tested for:
.antibodies
to HIV (HIV-I/HIV-2), HTLV (HTLV-I/II), HCV,
.
.
Syphilis.
The next revision and printing of the Circular is anticipated for the late fall of 2004. The
Circular of Information will continue to list West Nile Virus (WNV) NA T as unlicensed,
and performed with permission from Health Canada for research purposes.
Please note that the use of approved licensed test kits for NAT for Hepatitis
HIV-1 does not impact the transfusable
blood component labels.
If you have questions about this CBS Customer Letter, please
Corporate Quality Standards Department
at (613) 739-2591.
contact
C and
the CBS
Sincerely,
&'8
~~
Ms. Kitty Dunlop,
Director,
Corporate Quality Standards,
Regulatory Affairs and
Quality Assurance
R:\Customer
Letters\2004\C
of I customer letter NAT HCV HIV-1-RA approved.doc\515.500.1
IiI