Candida albicans Skin Test Antigen for Cellular Hypersensitivity
(CANDIN®) is a clear, colorless, sterile solution with
a pH of 8.0 - 8.5. The antigen should be administered intradermally according
to the directions included under DOSAGE AND ADMINISTRATION of this package
CANDIN® is made from the culture filtrate and cells of
two strains of Candida albicans. The fungi are propagated in a chemically
defined medium consisting of inorganic salts, biotin and sucrose. Lyophilized
source material is extracted with a solution of 0.25% NaCl, 0.1 25% NaHCO3
and 50% v/v glycerol. The concentrated extract is diluted with a solution
of 0.5% NaCl, 0.25% NaHCO3, 0.03% Albumin (Human) USP, 8 ppm
polysorbate 80 and 0.4% phenol.
The skin test strength of CANDIN® has been determined
from dose-response studies in healthy adults. The product is intended
to elicit an induration response 5
mm in immunologically competent persons with cellular hypersensitivity
to the antigen.
The potency of CANDIN® is measured by DTH skin tests in
humans. The procedure involves concurrent (side-by-side) testing of production
lots with an Internal Reference (IR), using sensitive adults who have
been previously screened and qualified to serve as test subjects. The
induration response at 48 hours elicited by 0.1 mL of a production lot
is measured and compared to the response elicited by 0.1 mL of the IR.
The test is satisfactory if the potency of the production lot does not
differ more than 20% from the potency of the IR, when analyzed by the
paired t-test (two-tailed) at a p value of 0.05.
The potency of the IR is monitored by DTH skin testing. Persons included
in the potency assay are qualified as test subjects by receiving four
skin tests with the IR from which a mean induration response (mm) is calculated.
Current skin tests with the IR must wshow that the potency of the IR has
not changed more than 20% from the mean qualifying response in the same
test subjects, when analyzed by the paired t-test (two tailed) at a p
value of 0.05. The required induration response at 48 hours to the IR
is 15 mm 20%.