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Technical specification for DTN 106: The use of a drug testing device for the identification of controlled drugs (example section 69)

Published 24 July 2026

69.1. Introduction

69.1.1. This specification accompanies FSA DTN-106 (68), the FSA-specific requirements (70) and the training and competency requirements (71).

69.1.2. This document outlines a specification for validation testing that shall be undertaken for a drug testing device (DTD) to be considered an approved DTD for the undertaking of FSA DTN-106.

69.1.3. The outcome of this validation testing shall be made available as required by the Regulator.

69.1.4. This testing shall be undertaken by a suitably accredited or certified laboratory.

69.2. Scope

69.2.1. DTDs for the context of this FSA refers to any specific instrument, device and model that meets the requirements set out in this document and does not refer to an overarching identification technique.

69.2.2. To be considered a DTD for the undertaking of this FSA, the device shall:

a.    Have the ability to identify a specified controlled drug(s), to the requirements set out in 69.4. Devices that are only capable of identifying a family of drug (e.g. opiates) shall not be used for this FSA.

b.    Have an assigned cut off purity for positive identification of each controlled drug of interest (CDOI). Such that it shall not be utilised to identify drugs at trace purity levels or contamination.

c.    Have an assigned minimum operational quantity for use, or minimum area for use (for point and shoot devices), set by the manufacturer. However, any sample below 100mg should not be analysed under DTN 106 and should be sent to the laboratory for analysis under DTN 103 (as per the FSA specific requirements).

d.    Undergo testing and approval under a centralised process to show the requirements for this document are met and shall not be approved for use by individual police forces.

e.    Have an associated validation certificate, displaying the results of the testing, issued by the centralised testing organisation, such that end-users are aware of the limitations of the device.

69.2.3. If the device is not ‘point and shoot’, a portion of the drug shall be required to be removed for analysis. In this instance, the amount of sample being tested shall cover the detection area of the instrument.

69.2.4. If the removed portion cannot be recovered after testing, there shall be a sufficient quantity remaining for additional testing if required, otherwise the sample is not suitable for testing under this FSA.

69.2.5. Samples that require a ‘recovery’ step shall not be tested under this FSA.

69.2.6. Any DTD or sample type that does not meet the criteria above for use in this FSA is not exempt from the Code and is considered non-compliant.

69.3. Evaluation Requirements for DTD Approval

69.3.1. The evaluation and approval of DTDs under this FSA shall be undertaken through a centralised process as authorised by the FSR and adhering to Annex A of this document.

69.3.2. DTDs used in the undertaking of this FSA shall demonstrate the requirements of this specification have been met, including:

a.    Any DTD previously approved under the Home Office Circulars 015/2012, 013/2014 and 005/2017.

b.    Any DTD previously approved under any other mechanism, such as by Border Force.

69.3.3. Any additional controlled drugs to be identified by the DTD that were not included in original testing shall undergo the full validation testing as per this specification before the DTD can be used for that substance.

69.3.4. Any change to a DTD that shall result in verification testing to demonstrate the DTD continues to meet the requirements set out in this specification includes:

a. A change to the manufacture of the DTD such as:

i. Materials used in the manufacture.

ii. The company carrying out the manufacture.

b.    A change to the mechanism by which the device identifies a controlled drug.

c. Software updates on digital devices.

69.3.5. As a minimum, each DTD shall undergo evaluation to demonstrate:

a. Sensitivity

i. That the device meets the acceptance criteria (69.4.1) for correct identification of the CDOI when present around the cut off purity, at the minimum operational quantity assigned for use.

b. Specificity

i. To ensure negative identification where the CDOI is absent or at a purity below 50% of the assigned cut off (see 69.4.2.a).

ii. This is to ensure the device does not falsely identify other drugs, trace purities or contamination as the CDOI.

69.3.6. The minimum requirements for evaluation of the DTD that shall be used to show the DTD meets this specification are outlined in Annex A.

69.4. Testing requirements acceptance criteria

69.4.1. Sensitivity

a. The DTD shall demonstrate a true positive rate as good as 90%, with a 6% margin of error, at a 95% Confidence Interval (CI) or equivalent^{[footnote 1]} for each CDOI, around the CDOI’s assigned cut off purity (within +20%) and using the minimum operational quantity (see 69.7.2.a).

69.4.2. Specificity

a.    The DTD shall demonstrate a true negative rate of at least 95%, with a margin of error of 5%, at a 95% CI (see 69.7.2.c) at:

i.        50% (+/- 10%) of the assigned purity cut off for the CDOI at the minimum operational quantity;

ii.        and where CDOI is absent but structurally similar drugs are present at a high purity (appropriate to the structurally similar drug)

b.    Where the false positive rate for the DTD is greater than 5% for the CDOI this shall be subject to greater scrutiny and review of the circumstances prior to approval.

69.4.3. For DTDs that use scoring to identify a substance, the level or percentage at which a positive result is indicated shall be recorded and this shall be made clear on the validation certificate.

69.5. Usability measurables

69.5.1. The role of the environment and purpose of the device shall be considered during the testing process to assess how individual parameters may impact the use of the device as per the manufacturer’s instructions.

69.5.2. The following usability measurables should be tested for each device prior to approval, the results of which shall be included on the associated certification (or a statement shall be present on the certificate to make clear that the measurable has not been included in the testing):

a. Length of time per test

b. Portability and performance in different environmental conditions

c. End user requirements (non-scientific personnel), including any level of interpretation of the results

i. Specific considerations shall be made for the end user’s understanding of ‘negative’ and ‘inconclusive’

d. Maintenance of the DTD

e. Install/set up requirements

f. DTD lifespan

g. Power supply/battery life

h. Health and safety

69.5.3. The DTD shall not alter or damage the material being tested (for example by overheating the material or packaging).

69.6. Limitations of use

69.6.1. The limitations of each DTD shall be recorded and clear to the end-user.

69.7. Annex A

69.7.1. This annex sets out the evaluation requirements for each device, per CDOI. Any device shown to be tested against the below requirements and meeting the acceptance criteria set out in 69.4 may be approved for use.

69.7.2. Through a centralised process, a testing regime shall be designed such that each DTD shall be evaluated against:

a. A statistically derived number of illicit samples, calculated using the requirements set out for the acceptance criteria, containing the CDOI at:

i. A purity within + 20% (i.e., 1.2x) of the assigned cut off, based on the availability of appropriate samples;

ii. A purity +200% (i.e., x2) of the assigned cut off

b. 6 positive controls per CDOI (Certified Reference Materials)

c. A statistically derived number of negative control samples, calculated using the requirements set out for the acceptance criteria:

i. CDOI at a purity 50% (+/- 10%) of the cut off to demonstrate the device does not make a positive identification at this level.

ii. Cutting agent only.

d. Other substances where available for the drug being tested. For each substance tested under this section, a statistically derived number of samples shall be evaluated, calculated using the requirements set out for the acceptance criteria.

i. Other controlled drugs shall be tested per CDOI. Considerations should be given to controlled substances commonly seized by the police.

ii. At least a further 10 drugs which are structurally related, including isomers, to the CDOI shall be tested. This shall include at a low purity and a high purity at the minimum operational quantity, to show that false positives do not increase with increased purity of similar drug.

iii. At least a further 10 substances commonly found in samples with the CDOI, such as cutting agents and pharmaceutical products.

e. Solvents. For each solvent tested under this section, a statistically derived number of samples shall be evaluated, calculated using the requirements set out for the acceptance criteria.

i. At least 2 common cleaning solvents shall be tested to show they do not interfere with the produced results.

f. Packaging

i. Where a DTD is manufactured as capable of through-barrier testing, this shall be accounted for as part of the testing protocol. For reasons of practicality this FSA is restricted to clear packaging, therefore the tests to show DTD sensitivity and specificity for through-barrier DTDs will be conducted through common clear packaging materials.

ii. If the result is impacted by any of the tested packaging materials, then the test is considered to have failed and the DTD cannot be used through-barrier.

69.7.3. Sampling

a. The identity of illicit samples used for testing shall have been previously analytically identified and purity determined by a laboratory undertaking DTN 103.

b. Illicit samples will be selected from all DTN 103 providers in England and Wales to ensure the drug market is appropriately represented.

69.7.4. When selecting substances other than the controlled drug of interest for testing, considerations should be made for the drugs the DTD is being used for. It may be beneficial to standardise the substances used for testing where DTDs are being used to identify multiple drugs of interest.

69.7.5. As the testing is undertaken using illicit samples, should the average purities of illicit drugs substantially change, the validation testing should be undertaken again.

69.8. Record of testing

69.8.1. The evaluation protocol and results of each test for each DTD shall be recorded, retained and made available.

1. (i.e., the minimum true positive rate for each DTD once accounting for the margin of error at a 95% CI should be greater than or equal to 84%) ↩