1. Scope of this disclaimer
This disclaimer applies to the diagnostic products described on diagnosticsolutionsgroup.com, including drug-checking lateral-flow test strips (fentanyl, xylazine, medetomidine, nitazene, benzodiazepines, and custom multi-panel configurations), the rapid sickle cell test, the rapid COVID-19 / Influenza A and B antigen test, custom-developed assays, and any artificial-intelligence-assisted result-interpretation tools we may offer alongside those products.
It supplements the Terms of Use and the Privacy Policy. It does not replace product-specific instructions for use (IFU), regulatory letters, or signed purchase agreements, which control as to the products they cover.
2. Product class and regulatory status
Our drug-checking products are lateral-flow immunoassay test strips intended for the qualitative detection of specific analytes. The applicable regulatory status varies by analyte, by formulation, by intended use, and by jurisdiction. The status that governs a given product is set out in the labeling and IFU shipped with that product, not on this site.
In broad terms:
- Some drug-checking strips are marketed and sold "For Forensic Use Only" (FUO). These products are intended for the analysis of substances that have been seized, surrendered, found, or otherwise removed from a person, or for harm-reduction "drug-checking" workflows where the strip is applied to the substance itself rather than to a clinical specimen. FUO products are not intended for clinical diagnostic use, are not intended to be used to diagnose a medical condition, and have not been cleared or approved by the U.S. Food and Drug Administration for clinical diagnostic purposes.
- Other diagnostic products in our portfolio are FDA-cleared for specified clinical indications, or carry an Emergency Use Authorization (EUA) where applicable. The clearance or authorization document defines the indication for use. Use outside the cleared or authorized indication is the user's responsibility.
- Products supplied internationally may carry registrations, certifications, or authorizations from other regulatory bodies. Status varies by country.
If you are unsure of the regulatory status of a specific DSG product, request the product's IFU and a copy of the relevant regulatory letter through the contact address below before you place an order.
3. Sold to qualified institutional buyers only
DSG sells its products to qualified institutional buyers, including state and county health departments, harm-reduction organizations, hospitals and large clinical systems, federal contract distributors (including SDVOSB-certified distributors operating under FSS, DAPA, ECAT, and similar vehicles), corrections and reentry programs, and national and international government health authorities.
This site is not a consumer storefront. No DSG product is offered for sale to individual consumers through this site. Pricing, specifications, and program descriptions are general information only and are not an offer to sell. All purchases are made under separately signed written agreements that govern the terms of supply.
4. Buyer's responsibility for jurisdictional legality
The legal status of drug-checking test strips varies meaningfully by U.S. state, by U.S. county and municipality, and internationally. Some jurisdictions have decriminalized or expressly authorized possession, distribution, or use of such products. Others have not. State authorization for one analyte does not automatically extend to others; some recent state actions (for example, Ohio's October 2025 Executive Order) have specifically named additional analytes such as medetomidine, nitazene, and benzodiazepines, while other states still authorize only fentanyl detection.
Buyers are solely responsible for verifying the legality of purchasing, possessing, distributing, and using DSG products in their jurisdiction. DSG provides general information about the regulatory landscape on request, but we do not provide legal advice and we do not represent that any particular product is legal in any particular jurisdiction.
5. Intended use; interpretation of results
Test results from our products require interpretation by qualified personnel who have been trained on the specific assay. Lateral-flow drug-checking strips are qualitative screening tools. They report the presence or absence of immunoreactive material above a defined threshold. They do not quantify the concentration of an analyte and they do not identify the specific compound within an analyte class.
- A negative result does not exclude the presence of the target analyte at concentrations below the strip's detection threshold, nor does it exclude the presence of structurally related compounds outside the assay's reactive class. A negative result also does not establish the safety of any substance.
- A positive result indicates the presence of immunoreactive material that the strip recognizes. A positive result does not, by itself, identify which compound is present, distinguish between members of a class, or quantify how much is present. For clinical, evidentiary, regulatory, or research purposes where identification or quantification matters, orthogonal confirmatory testing (for example, gas chromatography or liquid chromatography coupled with mass spectrometry) is recommended.
- An invalid result (no control line) means the test did not run correctly and the result must be discarded.
6. The drug supply changes faster than any single test
The unregulated drug supply in the United States and globally is changing rapidly. Novel adulterants, including new nitazene analogs, novel benzodiazepines, designer fentanyl analogs, and unfamiliar veterinary tranquilizers, appear on a timescale that no commercially available immunoassay can fully keep pace with. No drug-checking strip currently in production detects every compound that may be present in a given sample. A negative result on any specific strip means only that the targeted analyte class was not detected at or above the strip's threshold; it does not mean the substance is "safe."
7. Known interferences
Lateral-flow immunoassays can be affected by interfering substances commonly found in the unregulated drug supply. Caffeine, lidocaine, diphenhydramine, certain cutting agents, and a number of other widely used adulterants have been documented in peer-reviewed literature as potential sources of false positive or false negative results on some immunoassay drug-checking strips, depending on the strip's antibody, the cutoff, the sample preparation procedure, and the concentration of the interferent. Programs using DSG products should follow the sample-preparation steps in the product IFU, should be aware of known interferences for the specific strip in use, and should consider orthogonal confirmation where the result will drive a consequential decision.
Recent peer-reviewed work has examined interference patterns for nitazene-class drug-checking strips in particular, including a 2025 study in Harm Reduction Journal led by researchers at Brown University (Marland and colleagues) which evaluated commercially available nitazene strips against authentic samples and characterized cross-reactivity with related compounds. We track that literature actively and adjust our technical guidance as it evolves. Programs deploying DSG strips can request the current technical bulletin for any product through the contact address below.
8. AI-assisted interpretation
For certain products (currently the rapid sickle cell test, with similar capability planned for additional products), we offer an artificial-intelligence-assisted interpretation aid that uses a smartphone camera to read the strip and report a result. This capability is a decision-support aid. It is not a substitute for clinical judgment, and it does not replace the requirement for a qualified clinician to evaluate the patient and the test in context. The aid should be used together with the visual read by the operator, with patient history, and with any orthogonal testing the clinical situation requires.
9. Not intended to diagnose, treat, cure, or prevent disease
Except where a specific product carries an FDA clearance or Emergency Use Authorization for a defined clinical indication, the products and information described on this site are not intended to diagnose, treat, cure, or prevent any disease or medical condition. Information on this site is provided for general educational and procurement reference. It is not a substitute for evaluation, diagnosis, or treatment by a qualified healthcare professional.
10. No warranty of accuracy or completeness
We work to keep the information on this site current and accurate. However, regulatory status, scientific understanding, the composition of the drug supply, and program design recommendations all evolve. We make no warranty that information on this site is current at the moment you read it, or that it is complete for your particular use case. Any warranty applicable to a specific DSG product is set out in that product's labeling and the relevant signed purchase agreement, not on this site.
11. Forward-looking statements
This site may include statements about products in development, planned regulatory submissions, anticipated capabilities, or expected program timelines. Those are forward-looking and depend on factors outside our control. Forward-looking statements should not be relied on as commitments or as the basis for any procurement decision.
12. Contact for product technical questions
For questions about a specific product's regulatory status, intended use, sample preparation, interpretation guidance, known interferences, or the current technical bulletin, contact our team at Info@diagnosticsolutionsgroup.com with the subject line "Product Technical Question." Please identify the specific product, lot number if available, and the question you are trying to answer.