Standards Development

Scope

This document specifies requirements for the manufacture and onsite utilization of test kits and portable electronic devices used for the collection, detection and reporting of controlled substances in the field. It covers:

a) manufacturing requirements for product design, production and quality control;

b) onsite use requirements for operation, interpretation of results and safety management;

c) records and reporting requirements; and

d) information to be supplied by manufacturers to enable effective onsite use.

This document focuses on equipment used for presumptive screening in field settings, including reagentbased kits, swabbased devices and portable spectrometers. This document does not include specific test protocols for laboratory confirmation, regulatory classification of substances, or clinical diagnostic use.

Purpose

The surge in drug crimes and their widespread infiltration into daily life, further highlighted by UNODC statistics (according to the World Drug Report 2024, approximately 292 million people used drugs in 2022, a 20% increase over the last 10 years), demands a more proactive and aggressive response from law enforcement agencies. Waiting for precise laboratory analysis of seized narcotic substances has significant limitations. Therefore, the importance of "On-site Drug Detection" is being emphasized to rapidly confirm the presence and specific type of these substances in the field.

However, behind the speed and convenience of on-site drug detection lie inherent limitations such as issues with 'reliability,' 'complexity,' and 'environmental sensitivity.' As numerous types of kits and equipment for detecting various drugs are introduced fragmentarily, controversies over their reliability persist. In fact, cases of innocent citizens being arrested or investigative resources being wasted due to errors in field detection are continuously reported in several countries. This is a serious issue that not only severely infringes upon individual human rights but also leads to public distrust in the entire judicial system. While field testing offers speed and convenience, its improper use may cause significant risks to rights and judicial trust.

 From a forensic science perspective, on-site drug detection exhibits unique characteristics. In traditional forensic science, a clear distinction has been made between the crime scene as a place to 'collect' evidence and the laboratory as a place to 'analyze' it. However, with on-site drug detection, the entire forensic process—from evidence collection, analysis, and interpretation to reporting—occurs within the single space of the field. In other words, "The crime scene has expanded to encompass the laboratory."

Considering this, in addition to the minimal validation of individual technologies and equipment for onsite drug detection, it is necessary to focus more on the essence of forensic science: providing 'decision-making support' within the investigative process. Guidelines for the analysis, interpretation, and reporting of evidence that reflect the specific characteristics of the field must be established, and interoperability must be enhanced through systematic data management. The education and safety of field practitioners, as well as the transparency of product verification information, must also be improved. This standard aims to provide comprehensive guidelines on the requirements and utilization of drug detection kits and equipment in the field. Key topics include the following:

a) Defining minimum manufacturing requirements for the design, production, and quality control of drug detection kits and equipment used in the field.

b) Specifying field-use requirements for end-users concerning equipment operation, result interpretation, and safety management.

c) Establishing requirements for the documentation, recording, and reporting of the results from the use of drug detection kits and equipment.

d) Stipulating manufacturer requirements for quality management systems and information disclosure.

On-site drug detection is an indispensable tool in modern drug crime investigation. However, its improper use can lead to violations of citizens' human rights and foster distrust in the judicial system. The international standardization of on-site drug detection will contribute to resolving these issues.