POST 00593E : SHAKE TEST
Follow-up on POSTS 00571E, 00574E, 00575E, 00579E and 00590E
17 August 2003
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This posting contains 3 contributions. The first is from Dr. Sam Okinor
(mailto:[log in to unmask]) from WHO/AFRO followed by that of Samuel Kaamau
(mailto:[log in to unmask]) from EPI/Kenya. Finally, Kohl
(mailto:[log in to unmask]) from Glaxo Smith Kline Biologicals
presents three slides illustrating by the shake test the effect of freezing
on DTP-HepB vaccine. The slideshow is attached making this posting rather
heavy!
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This is a very interesting discussion on the "Shake Test". I would like to
refocus our attention on the practical aspects of the safety of the vaccine
when applied to the child. While still running the programme at country and
lower level, our emphasis was on safety first and so the teaching was that
1. Once the staff at that lowest level on opening the fridge sees and
suspects that the vaccine has been frozen or sees that it is frozen or is
not fully sure that the vaccine grossly appears as normal as usual, then
that vaccine should not be used. If an alternative vaccine is available it
should then be used. BUT the staff suspicion should not go unreported to
the next level usually the supervisor and preferably vaccine put aside
clearly labeled for further scrutiny.
2. Should the staff be competent in the "Shake " test that as far as my
experience goes takes time to master and needs fairly repeated practice
then the staff should go ahead and carry out the test. If the staff is
still not convinced in any way, the safety factor must be applied i.e. the
vaccine should not be used.
The bottom line for all this is that it takes very long to build the
confidence of the community in immunisation and its benefits but takes one
incident for this to literally CRASH!!!
3. As for the time the control vial should be frozen, I do fully agree
with the comments of in that it depends on the vial size, the
manufacturer, the type of fridge and a host of other factors. Again the
bottom line is that the control vial should be frozen solid. My own
practical tests done in the late 80s when I was very much involved in
teaching at the district and lower levels revealed that if the vial was not
fully frozen, the test would not be very clear for teaching purposes hence
our insistance that once the staff is not sure then staff should not go
ahead to use the vaccine.
I am sure that persons who are still involved at lower levels may have more
recent experiences.
Sam
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After going through the discussions on shake test I strongly feel that we
should emphasize to the health workers that the control vial should be
solidly frozen and ensure all the liquid inside the vial is completely
frozen without any possible pocket inside.
I think the issue of how and how long may confuse the health workers. The
question is why bring this issue now when most of the EPI programmes are
over 20yrs and not much complaints have been received from the operational
staff at health facility level.
Sam Kamau,
National EPI Logistician, Kenya
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I annex 3 powerpoint slides with frozen versus non-frozen DTP-HepB 10 dose
or DTP-HepB+Hib (2 dose vials).
I left the vaccine overnight in the freezer at my home.
I do believe that the freezing effect is very visible and the sedimentation
rate very fast in the frozen samples as opposed to the non-frozen ones.
Very best regards,
Director Worldwide Vaccinology & Vaccine Education & Training
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