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The Development of Hemoglobin A1c (HbA1c)
fractionation quantitative analyzer
Promotion of Hemoglobin
A1c in VENSONIC seminar
Today people know that HbA1c is highly important
for diabetes study, however, in the 1970s, when HA-8110
was being developed, nobody knew about HbA1c in Japan,
except some research pioneers. The measurement method
itself was not general so that HbA1c was not applied
in clinical settings. Only some researchers were studying
the glycation of blood hemoglobin (binding of hemoglobin
and sugars or its metabolites in blood) of the diabetics.
There were not many literatures about HbA1c, and none
in Japanese. Some was performing the measurement of
HbA1c using mini column method in the U.S.A. Other
than that, it was not too much to say nobody knew
what HbA1c was and what it was for. |
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HA-8110 appeared in overseas
journal |
Under the circumstances, practical application of
the measurement of HbA1c achieved by HA-8110 created
a sensation all over the world as well as in Japan.
The usability of HbA1c in diabetes screening and as
patients’ control indicator was obvious, but
HbA1c measurement by HPLC method was not covered by
insurance in those days. (HbA1 was covered by insurance.)
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| ARKRAY talked to academic
societies and succeeded in organizing a study group
about HbA1c with doctors noted for their diabetes
study. For discussing the study outcomes, we held
VENSONIC seminars all over in Japan. VENSONIC is a
combination term of “venture” and “sonic.”
It was made by a leading authority on diabetes, Dr.
Shigeaki Baba, Kobe University that time, with the
hope that ARKRAY’s venture spirit and new knowledge
would spread further. VENSONIC seminar invited leading
A1c researchers from abroad and became highly recognized
as ARKRAY’s study support activity. |
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The First Vensonic Seminar
(1983)
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After this, the success of this kind of research was recognised
and it became covered by medical insurance. Hbf (Hemoglobin
F), which was not believed to exist in adults, was then
recognised using this method and came to be used as part
of the HPLC method.
We saw diabetes in proper perspective and continued our
study firmly believing that HbA1c was necessary for diabetes
testing. This made basis of today’s diabetes testing
and it is still our pride.
Development
of Cap-Piercing mechanism
In 1994, about 13 years after the development of HA-8110,
the third generation of the HA series, HA-8130 was released.
| The greatest feature of
HA-8130 is the Cap-Piercing mechanism, where blood
sample is drawn into the system without removing a
cap of a vacuum blood collection tube. Before Cap-Piercing,
blood drawing was performed in a troublesome and dangerous
way; a cap of each vacuum blood collection tube was
removed before drawing blood sample and it was put
back on after drawing. The Cap-Piercing method not
only reduced workload of opening and closing caps
but also helped to protect lab technicians from possible
infections. |
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HA-8131(1994)
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We faced difficulties in the development of the Cap-Piercing
mechanism. After an injection needle sticks a cap of a vacuum
blood collection tube several times, the needle tip gets
worn and dull, and the needle can no longer stick a cap.
Since HA-8131 blood sampling needle sticks tens of thousands
of caps annually, we needed to come up with an idea of a
needle which would not get dull even in frequent sticking.
We came up with an idea: traditional phonograph needle.
A phonograph needle traces record grooves, which are like
sandpaper, at high speed, but the needle does not become
worn easily. This is because the needle tip is made from
the substance with high degrees of hardness such as diamond
or sapphire. In addition, the diameter of a phonograph needle
tip is 0.5mil (about 0.012mm) and that is adequate tip for
sticking the rubber cap of a vacuum blood collection tube.
We talked about the idea to a jewelry maker, who handled
diamond and sapphire, and got a response that sapphire could
be set on the tip of the injection needle. We made a prototype
needle with sapphire and performed a durability test. The
result showed that the sapphire-tipped needle remained sharp
after more than 100,000 sticks. This is how the piercing
needle, an essential item for the Cap-Piercing method, was
developed. |
HA series was developed in cooperation
with the major general chemical maker, and was evolved furthermore
with the collaboration from a jewelry maker, who has no
relation with clinical test. Now HA series has become a
product with no equal. HA series went through improvements
and they are widely used as a flagship model in the A1c
measurement even today. We believe that the performance
of HA series reflects the fact that we took all the available
means, continued challenging, and did not give up on the
development of better instrument.
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Cap-Piercing method
(adopted to HA-8160) |
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