Schick test for skin#

Injection, a diameter of the reaction for each injection site shall beĬalculated by averaging two diameters of the reaction measured at rightĪngles to each other. Left Right Left Right Left Right Left RightĪ. It will permit comparable randomization of injection sites: into each of the four guinea pigsĪccording to either the following scheme, or in another scheme, provided Standard (chart designations S L and S H) shall be injected The low and high dilutions of the product (chartĭesignation P L and P H) and the low and high dilutions of the Same as those of the standard toxin and estimated to have the same The low and highĭilutions of the Schick test dose of the toxin under test shall be the are capable of eliciting graded erythematousĭermal reactions between 10 mm. Standard shall be those amounts of a Schick test dose of the standard Schick Test, shall be prepared in sterile buffered saline pH 7.4Ĭontaining 0.2 percent gelatin. Not show a graded response to the graded dilutions of the Schick test The test is not valid if the guinea pigs do

Schick test for skin#

The denuded skin of each animal shallīe sectioned into four equal areas at right angles to the vertebralĬolumn to provide two injection sites in each of the four areas, one onĮach side of the vertebra. Removed from the back and both sides of each guinea pig without Random distribution of eight intradermal injections. Used, all of the same strain and each of a size that will permit a At least four healthy female guinea pigs shall be The product under test and of the standard. The dermal reactivity of each lot of the product shall be determinedįrom the results of simultaneous guinea pig intradermal potency tests of Injected intradermally into a guinea pig induces an erythematous A minimum reaction dose is that amount of toxin which when Is the smallest amount of toxin that will kill a guinea pig weighingĪpproximately 250 gm. Or 400,000 minimum reaction doses per milliliter. Prepared from a parent toxin which has been demonstrated to be stableĪnd which contains no less than 400 minimum lethal doses per milliliter Diphtheria Toxin for Schick Test shall be Shall not contain ingredients known to be capable of producing The Corynebacterium diphtheriae for preparation of the parent toxin 650.3 Manufacture of Diphtheria Toxin for Schick Test. Intradermally in a guinea pig, will induce an erythematous reaction of Standard Diphtheria Antitoxin and injected The standard is that amount of the standard that, when mixed with 0.001 Standard Diphtheria Toxin for Schick Test shall be used toĭetermine the Schick test dose of the product. The growth of Corynebacterium diphtheriae. Test, which shall be a preparation of a diphtheria toxin obtained from The proper name of this product shall be Diphtheria Toxin for Schick Subpart A-Diphtheria Toxin for Schick Test 21 FOOD AND DRUGS 7 false Diphtheria Toxin for Schick Test A Subpart A FOOD AND DRUGS FOOD AND DRUG ADMINISTRATION, BIOLOGICS ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR DERMAL TESTS