QL Biotek at MEDICA 2023: New Drug of Abuse Assays, Custom Cut-offs and Strep A for the EU Market

From 13 to 16 November 2023, the QL Biotek team exhibited at MEDICA in Düsseldorf, Germany — one of the year's key meeting points for IVD buyers, importers and distribution partners. The booth reflected the direction the company has taken over the past year: a growing R&D bench, a faster response to market demand, and a product pipeline built around two commercial realities — flexible cut-off specification for drug of abuse testing, and regulatory preparation for the European Union.

Below is a practical summary of what was shown and what it means for partners evaluating rapid-test suppliers.

New assays and IVDR-track products on the stand

The company used the exhibition to introduce products that had recently come out of development, notably three additional entries in the Drug of Abuse series — ETO, XYL and LSD — alongside a group of assays being prepared under the IVDR framework.

The Drug of Abuse portfolio remains the largest and most actively expanded line. It is a lateral-flow based family designed for the usual screening settings: workplace and forensic screening, rehabilitation clinics, pain management programmes, and point-of-care triage. What differentiates the range commercially is not the assay format itself but the ability to match the cut-off to a customer's target market.

Custom cut-off: the main commercial lever in drug screening

Screening thresholds are not universal. A cut-off that satisfies a workplace programme in one country will fail a forensic or clinical requirement in another, and buyers frequently need to align with a local regulator, an internal policy or a reference method rather than with a fixed factory specification. QL Biotek's position is to treat the cut-off as a configurable parameter rather than a fixed product attribute, so a distributor can respond to tenders without changing supplier.

Cut-offs currently available across the range, expressed in ng/ml:

For importers, the practical point is this: when a project requires a threshold outside the list above, the request should be raised at the quotation stage rather than after sampling, so that validation work and stability data can be aligned with the agreed specification.

Strep A: a product built around European demand

The second focus of the booth was the Strep A Rapid Test Device, a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen in throat swab specimens, intended to aid in the diagnosis of Group A Streptococcal infection.

The clinical rationale behind the assay is straightforward. Streptococcus pyogenes is a non-motile, gram-positive coccus belonging to Lancefield group A. Untreated group A streptococcal infection can progress to serious complications — among them pharyngitis, respiratory infection, impetigo, endocarditis and meningitis, as well as rheumatic fever and peritonsillar abscess. A rapid antigen test at the point of care allows a clinician to make a treatment decision during the same consultation instead of waiting for culture.

Europe is where the volume sits for this format, which is why the company is working through the regulatory route rather than relying on a CE-marked-in-name-only strategy: an application is in progress for the IVDR professional-use certificate for the Strep A device, and a separate self-testing certificate is in the planning stage. Partners who need an IVDR-marked Strep A product for EU distribution should factor these timelines into their own submission planning and confirm current status directly with QL Biotek before committing to launch dates.

What this means for distributors

• Portfolio depth. The Drug of Abuse line now covers a wider set of targets including newer screening requests, giving distributors a single-source option for multi-analyte panels.
• Tender flexibility. Adjustable cut-offs make it possible to bid on specifications that would otherwise require a different supplier.
• EU compliance track. Strep A is being moved onto the IVDR path, with professional-use certification under application and self-testing certification planned.
• Private label and uncut sheet. Partners requiring branded packaging or uncut membranes for local assembly can discuss these options alongside the finished device.

Buyers who met the team in Düsseldorf are continuing technical discussions through the standard export channel; anyone who did not attend can request the current catalogue, specification sheets and regulatory status updates through the contact page on qlbiotek.com.

FAQ

Can the cut-off of a QL Biotek Drug of Abuse test be changed to match my market?

Yes. Flexible cut-off customisation is a core feature of the Drug of Abuse series. The published values in the table above are the current standard specifications; if your target market or tender requires a different threshold, raise it during the enquiry stage so that the specification can be confirmed before sampling and validation.

Which specimen does the Strep A Rapid Test Device use?

It is designed for throat swab specimens. The assay is a rapid chromatographic immunoassay that qualitatively detects Strep A antigen to aid in the diagnosis of Group A Streptococcal infection.

Is the Strep A test already IVDR certified?

The application for the IVDR professional-use certificate is in progress, and a self-testing certificate is in the planning stage. Contact QL Biotek for the current status before fixing EU launch dates for your distribution network.