A custom molecular control is a specially developed product designed to meet your specific PCR testing needs. These controls contained the desired genome, testing workflows, and regulatory requirements, making them ideal for assay validation, development, or documentation.

Our tailored controls are ideal for: • IVD manufacturers optimizing molecular assays • Companies undergoing clinical validation or regulatory submissions (CE-IVD, FDA, etc.) • Developers of syndromic or multiplex PCR panels • OEM or white-label partners • Academic institutions or research groups working on molecular diagnostics

To evaluate feasibility and quote accurately, please provide: • Pathogen or desired genoma(s) including strain details • Desired control type: Amplification or Total (including extraction) • Matrix needed (e.g. respiratory swab, plasma, urine) • Intended use and platform compatibility • Format: lyophilized, liquid, bulk, or unit-dose • Expected volume and delivery timeline • QC criteria, concentration requirements, or any cross-reactivity exclusions

Yes. The MOQ is 3 units per configuration. This allows full QC and compliance with our production standards. For larger or recurring needs, we support long-term OEM planning.

• Feasibility: 2–3 weeks • Development & production: 4–6 weeks • QC and release: 1–2 weeks Timelines depend on microorganism type and project scope. After feasibility evaluation, we will send you a specification proposal sheet for your review and approval. Once agreement is reached, and at order reception, development to supply timelines start to count and will be confirmed by Vircell Logistics team

All controls are delivered as Research Use Only (RUO) unless agreed otherwise. Documentation includes: • Certificate of Analysis (CoA) • ISO 13485 support upon request Final validation and regulatory responsibility rest with the test developer.

Absolutely. We support OEM molecular controls, co-branded packaging, and private-label options with custom artwork, inserts, and labeling.

Our R&D and customer teams provide: • Feasibility confirmation and timeline estimates • Guidance on design and documentation • Real-time production updates • Post-sale support and re-batching assistance if needed

Send your request to: customisedsolutions@vircell.com. Include key project details and we’ll respond with a custom quote and estimated timeline.

Vircell AMPLIRUN® controls are designed as positive controls for conventional PCR or Real-Time PCR assays, facilitating the validation and monitoring of your molecular diagnostic systems.

These molecular controls include complete and purified DNA or RNA of the indicated microorganism. This allows amplification with any specific primer pair. The only exception is the PARVOVIRUS B19 control (MBC080), which is based on a plasmid with a specific gene and primers included.

The products are lyophilised and must be reconstituted: - DNA controls → 100 µl - RNA controls → 50 µl

The shelf life of Vircell PCR controls is 30 months for DNA and 24 months for RNA from the date of manufacture; as long as the storage recommendations described in the instructions for use of the product are observed.

Yes, Vircell DNA/RNA controls can be used on any nucleic acid amplification platform. The performance of our controls has been proven to be maintained regardless of the type of platform on which the technique is performed. It is not recommended to use DNA/RNA controls on platforms that perform nucleic acid extraction.

No, pre-extraction is not required as the controls include purified nucleic acids, ready to be used directly in the amplification reaction.

PCR controls are supplied lyophilised and, under these conditions, should be stored refrigerated (2-8°C). Once reconstituted, DNA controls should be stored at temperatures between -5 and -40ºC, while RNA requires temperatures between -70 and -90ºC. Vircell recommends making aliquots of the material after reconstitution to avoid potential freeze/thaw problems associated with reusing the same vial multiple times. The response of the controls to repeated freeze/thaw cycles has been tested, and both DNA and RNA remain stable. However, we recommend that users avoid unnecessary freeze/thaw cycles in order to avoid possible degradation or contamination of the controls.

As detailed in the instructions for use of the product, it is advisable to store aliquots of the controls to avoid unnecessary freeze/thaw cycles. If a lower concentration of the control is required, dilutions of the controls can be made and stored for a period of time, although our recommendation is never to store dilutions with a concentration of less than 1000 copies/µl as a reduction in the number of copies has been observed after prolonged storage or successive freeze/thaw cycles. If a lower concentration than that stated in the control manual is required, the necessary dilutions should be prepared just before use.

This is not a problem. After reconstituting the product according to the instructions for use of the product, it is possible to dilute the product to the concentration that best suits your requirements. However, care should be taken, especially with quantified controls, not to store very dilute aliquots (1000 copies/µl) as a reduced concentration is less stable to prolonged storage and freeze/thaw cycles and may alter the characteristics of the product.

Yes, many AMPLIRUN® controls are quantified, which makes them ideal for qPCR. If you are in doubt about the level of quantification, please contact us.

The quantification of our controls has been carried out by Real time PCR (Real time-PCR). The copy number was obtained using a specific sequence of the microorganism as a target. In real-time PCR quantification, a standard curve is used as a reference by comparing the amplification of a target sequence of the microorganism with a specific standard for each of the references quantified.

Repeated freezing and thawing of PCR controls is not recommended as the quality of the product may be affected, especially when the genetic material is not highly concentrated (<1000 copies/µl). The influence of freezing and thawing on product quality will depend on the type of control, RNA being more easily degradable than DNA. In any case, it is difficult to set a maximum number of freeze/thaws that will guarantee the quality of the process. Therefore, it is more convenient to reconstitute the vial upon receipt and prepare aliquots before freezing.

AMPLIRUN® products are not infectious because they only contain purified genetic material extracted from previously inactivated microorganisms. Vircell provides documentation certifying this issue upon request of its customers.

Vircell recommends using at least 1 µl of PCR control the first time it is used. In quantified controls 1 µl volume contains approximately 15000 copies of the microorganism, which allows up to 100 reactions to be performed with each vial. However, the user can prepare dilutions of the control and thus determine how many copies are needed to achieve a safe positive control in his PCR system. It is important to note that it is not advisable to use the controls at the detection limit (4 to 10 copies/control).

Vircell PCR controls offer significant advantages over other manufacturers: - Wide range of products including more than 120 infectious agents. - Positive controls suitable for use in conventional PCR and Real Time PCR - any platform can be used - Versatile product line: valid as amplification and extraction control - Most of the controls are quantified - Contain complete and purified DNA or RNA - any sequence can be amplified - Controls obtained from whole micro-organisms - Designed to avoid variability factors in PCR tests - Lyophilised presentation avoids high transport costs and improves stability - No need for dry ice for transport - Competitively priced for clinical diagnostic use.

The PCR controls currently in our catalogue are not encapsulated, but contain the complete, purified genetic material of the microorganism ready for use in amplification reactions.

The use of Vircell PCR controls avoids the main challenges faced by laboratories using their own in-house controls: - Limited quantity available - Difficulty in obtaining positive samples on esoteric or less frequent parameters - Non-standardised results; inconsistency between batches - Non-purified controls - presence of human or other micro-organism genetic material - Risk associated with working with infectious agents - Reduced stability The use of commercial PCR controls avoids these difficulties and provides advantages in terms of ease of use, long-term storability, standardisation, quality and consistency. In addition, laboratories in some countries are mandated to use commercial controls by quality accreditation groups.

AMPLIRUN® Total is designed as a complete external positive control, verifying all phases of molecular diagnostics: from nucleic acid extraction to amplification and detection. Its formulation simulates a real clinical sample in both composition and pathogen load, helping to validate the performance of the protocol under real conditions.

Once reconstituted, the AMPLIRUN® Total vial is handled in the same way as a regular clinical specimen. No additional treatment is required. The control contains whole inactivated microorganisms and must undergo DNA/RNA extraction and purification prior to amplification.

Each control includes inactivated pathogens in a simulated biological matrix, which reproduces the conditions of a clinical specimen. This allows the effectiveness of laboratory reagents, equipment and procedures to be realistically tested.

- AMPLIRUN® DNA/RNA are high concentration standards intended to validate the amplification and detection step only. They are useful for calculating assay sensitivity, reproducibility or detection limits. - AMPLIRUN® Total, on the other hand, is used as a total diagnostic process control, including nucleic acid extraction, with a low concentration to simulate a weak positive sample.

No. AMPLIRUN® Total is designed for single use only. We recommend not reusing the remaining contents of the vial to ensure the validity and consistency of the results.

These controls have a shelf life of 2.5 years from the date of manufacture, provided that the storage conditions indicated in the manual are respected.

The reconstitution volume can vary between 200 µL and 1 mL, adapting to different automated or manual extraction platforms. Please refer to the product catalogue or datasheet to verify the exact volume according to the reference.

No. All products in the AMPLIRUN® Total line contain completely inactivated microorganisms. Vircell can provide inactivation certificates if required for regulatory compliance or audits.

These controls are formulated to contain a low, but detectable pathogen load, allowing to simulate a clinical sample with weak positivity. This approach allows you to accurately verify that the entire diagnostic protocol (extraction, amplification and detection) works correctly, even under critical conditions. See the specific insert for each batch for the exact concentration.