Opened 12 years ago

Closed 12 years ago

Last modified 12 years ago

#37 closed enhancement (fixed)

D-Antigen Unit

Reported by: Gunther Schadow Owned by: Gunther Schadow
Priority: major Milestone: Revision 1.9
Component: Keywords:
Cc:

Description

Sanofi uses D-Antigen Units for listing. A reference is forthcoming. We have a request to assign a provisional code with the reference. CBER would confirm the definition of the unit at a later date. There is a certain urgency to this.

Attachments (3)

d-antigen-bulletin_1967_36(2)_209-218.pdf (524.9 KB) - added by Gunther Schadow 12 years ago.
D-Antigen paper attached, contains a reference to original unit paper
d-antigen-unit-lancet-1962.pdf (601.3 KB) - added by Gunther Schadow 12 years ago.
original D-antigen unit description, Lancet 1962
Gel diffusion test for D-antigen determination.doc (27.5 KB) - added by Gunther Schadow 12 years ago.

Download all attachments as: .zip

Change History (7)

Changed 12 years ago by Gunther Schadow

D-Antigen paper attached, contains a reference to original unit paper

Changed 12 years ago by Gunther Schadow

original D-antigen unit description, Lancet 1962

comment:1 Changed 12 years ago by Gunther Schadow

Owner: set to Gunther Schadow
Status: newassigned

Proposed symbol: [D'ag'U]

comment:2 Changed 12 years ago by Gunther Schadow

Type: defectenhancement

comment:3 Changed 12 years ago by Gunther Schadow

Resolution: fixed
Status: assignedclosed

the definition is good enough.

comment:4 Changed 12 years ago by Gunther Schadow

Additional input received:

I attached a file with the relevant text from the paper- the reference is included in the text (Beale and Mason, 1962).

In a further publication by Beale AJ and Ungar J (The Lancet, 1962, ii, 805, Potency and stability of combined pertussis, diphteria, tetanus and poliomyelitis (quadruple) vaccine), it is stated that "Standard preparations of all three types of poliovirus have been prepared and assigned a unitage such that a "D-line" of 24 mm. in the test described by Beale and Mason (1962) corresponds to 600 units of D antigen for each type".

Thus, the most accurate definition of D-antigen would be by saying that " A value of 600 units of D antigen per millilitre was historically assigned to an antigen concentrate which gave a line distance of 24 mm under the test conditions outlined by Beale and Mason, 1962 (see attached file)".

Changed 12 years ago by Gunther Schadow

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