scope:

This Protocol is intended to cover certification of drug testing sample collection and security equipment, including urine, whole blood, and serum blood sample collection, and encompasses required testing methods, design, and material requirements for this equipment.

This Protocol covers only the equipment that are used to collect and secure the biological matrices, and that come directly with the urine, whole blood, or serum blood. Blood collection vials (e.g., vacutainers) and associated equipment that come directly in contact with blood are considered medical devices and should comply with applicable US FDA or other relevant regulatory requirements and therefore not under the scope of this Protocol. Specifically, this Protocol covers the following:

⎯ the urine collection vessel and lid, also known as "collection cup" - the container and (if applicable) associated lid used to directly collect the urine from the donor;

⎯ the sample security bottles - containers in which the sample will be secured by the athlete and sent to a laboratory for analysis. Depending on the design of the sample security bottle, corresponding components like a security cap, lock ring, seals, security seal or other closure elements makes up the entire sample security bottle unit;

⎯ for urine samples, the content of the collection vessel may be transferred via pouring to the sample bottle(s) by the athlete, in most cases consisting of bottles representing an "A" and "B" sample. Sample A is used for initial testing and Sample B is for storage in case future testing of the sample is deemed necessary. In this case the sample security bottles are in direct contact with the urine sample; and

⎯ for whole blood and serum blood samples, the sample security bottles are designed to serve as an external container holding and securing the actual sample blood vial. In this case the sample security bottles are not in direct contact with the sample.

This Protocol does not cover accessory products that may be included with sample collection kits that do not come in direct contact with the urine or blood but are used with or provided with the sample containers.

Purpose

This Protocol establishes minimum requirements for the materials, design, construction, and performance of drug testing sample collection and security equipment, including, but not limited to, urine, whole blood, and serum blood sample collection. In addition, this Protocol establishes minimum packaging and labeling requirements for this drug testing sample and security equipment. This Protocol also establishes specific testing protocols to objectively evaluate drug testing sample collection and security equipment to assess its function, impact on sample integrity, and performance characteristics. Although various standards of drug testing programs exist, this Protocol addresses equipment requirements consistent with programs which meet World Anti-Doping Agency (WADA) global compliance standards as per the current version of the WADA International Standard for Testing and Investigations (ISTI).