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Supplemental Assay Method for the Evaluation of Tuberculin Purified Protein Derivative (PPD) Supplem

Supplemental Assay Method for the Evaluation of Tuberculin Purified Protein Derivative (PPD) Supplem 2025

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The document SAM 636.04 outlines a Supplemental Assay Method for evaluating Tuberculin Purified Protein Derivative (PPD) as per the U.S. Department of Agriculture regulations. It details the testing protocol, including materials, preparation steps, personnel qualifications, and performance of potency tests using guinea pigs. The document specifies procedures for sensitizing test animals, administering injections, interpreting results, and reporting findings. It also includes revisions made to previous versions and references relevant regulations.

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What is the PPD test for purified protein derivative?

TUBERCULIN PURIFIED PROTEIN DERIVATIVE, PPD is a test used to detect if you have a tuberculosis infection. It will not cause tuberculosis infection. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What is tuberculin purified protein derivative used for?

Tuberculin purified protein derivative (PPD) is used in a skin test to help diagnose tuberculosis (TB) infection in persons at increased risk of developing active disease.

What is the induration of purified protein derivative test?

The amount of swelling may be different for children, people with HIV, the elderly, and others at high risk. A small reaction, called an induration, at the site of the test (5 to 9 millimeters of firm swelling) is a positive result in people who: take steroids.

What is the purified protein derivative test?

The PPD skin test is a method used to diagnose silent (latent) tuberculosis (TB) infection. PPD stands for purified protein derivative. The positive immunologic response to PPD antigen is seen here. The size of the papule is over 2 cm in diameter.

What is the USDA supplemental assay method?

This Supplemental Assay Method (SAM) describes the test procedure used to determine the ratio of inoculum to medium for sterility testing that will result in a sufficient dilution of the product to prevent bacteriostatic and fungistatic activity, per title 9, Code of Federal Regulations (9 CFR), part 113.25(d).

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What are the side effects of tuberculin PPD?

Local side effects may occur at the injection site, including pain, discomfort, hematoma, scarring, pruritus, necrosis, ulceration, blistering, or swelling. In addition, fever, presyncope, or syncope may occur.

Is purified protein derivative test the same as Mantoux test?

The terms Mantoux, TB skin test, tuberculin skin test, and PPDs are often used interchangeably. Mantoux refers to the technique for administering the test. Tuberculin (also called purified protein derivative or PPD) is the solution used to administer the test.

Supplemental Assay Method for the Evaluation of Tuberculin Purified Protein Derivative (PPD) Supplem 2025

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What is the PPD test for purified protein derivative?

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What are the side effects of tuberculin PPD?

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