July 31, 2001
ADMINISTRATIVE ORDER
No. 41 series 2001
ADOPTION
OF APPROVED LIST OF BLOOD TESTING REAGENTS FOR USE OF BLOOD SERVICE FACILITIES
I. Rationale
One
of the thrusts of National Voluntary Services Program (NVBSP) is strengthening
of the Blood Safety Management. Some diseases that affect lives of people are
caused by viruses that can be transmitted through blood. These risks can be
decreased by ensuring safe blood supplies through collection from low risk
healthy voluntary blood donors, proper blood testing and processing and
rational blood use.
For
quality assurance of blood testing reagents, the goal is to identify specific
methods/reagents for use in Blood Testing. The use of appropriate and effective
screening tests is necessary to identify all possibly infected blood units and
donors with the least wastage of precious donations.
The
NVBSP Technical Committee was formed to evaluate technical issues relate to
NVBSP. Foremost is the choice of reagents used by the Program and come up with
a short list of reagents which will become the standard for all blood banks
nationwide. Due to number of reagent kits with limited data as basis for
evaluation, the Technical Committee decided to recommend the following
criteria:
For HbsAg, HIV Ab and HCV Ab kits:
Sensitivity – 100%
Specificity – at least
98%
For Malaria and Syphillis reagents:
Any available kit in the
market
As
such, the NVBSP Technical Committee has recommended a list of reagents that can
be used in testing of blood for transfusion – transmissible infection such as
HBV, HCV, HIV, Malaria and Syphillis. The Blood Testing Reagents for HBV, HCV
& HIV are categorized according to their sensitivity and specificity
indicators as reflected in their BFAD registration.
The
approved list as recommended by the Technical Committee of the National
Voluntary Blood Services Program will be updated based on the subsequent performance
evaluation results and registration with Bureau of Food and Drugs (BFAD), to
enable the manufacturers to be included or upgraded.
This
order is hereby issued to provide the standards for identifying methods and
purchasing blood testing reagents for the use of Blood Service Facilities.
II. Categories
of Blood Testing Reagents
CATEGORY
I – BFAD registered with a
Sensitivity of 100% and Specificity of 98% or above; recommended for NVBSP
Blood Banks/Centers for high volume or bath testing of blood samples.
CATEGORY
II – BFAD registered with a
Sensitivity of 98% or above and Specificity of 96% or above; may be used for
high volume or batch testing of blood samples upon the discretion of the Blood
Bank Head.
CATEGORY
III – rapid test; BFAD registered;
with a sensitivity of 98% or above and a specificity of 96% and above;
recommended for emergency testing only of small volume blood samples (i.e., not
more than ten samples).
MANUEL M. DAYRIT, MD,
MSc
Secretary of Health
(The list of
reagents by manufacturer was omitted by the author since it has an expiration
date and to give emphasis to the category of blood testing reagents.)
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