Quality Control · Molecular Diagnostics
Know Streck. Know Quality.
In molecular diagnostics, a failed step can mean a missed diagnosis.
Whether you catch it depends on what your control checks.
New to external quality control
Why 3rd Party Controls
The case for independent, third-party verification instead of relying on kit-included controls alone.
CLSI, CAP & CLIA defined
What Is Full-Process Molecular QC?
Why detection-only controls miss upstream failures, and what “full-process” actually means.
Ready to standardize
CAP/CLIA/CLSI-Compliant Transition Guidance
Step-by-step guidance for transitioning control materials across sites and platforms.
What’s new
Need Custom Oncology Controls?
Tell us about your oncology panel and our team will help you scope a custom control.
Here’s What Your Quality Control Doesn’t Actually Test
Most labs run one of two kinds of external control, and neither fully exercises the workflow. Synthetic nucleic acid controls skip lysis and extraction entirely, entering at amplification. Pellet- or swab-based controls require reconstitution and frozen storage. Neither processes the way a real specimen does.
These formats are the default because that’s what the workflow has always used. CLSI MM17 (Validation and Verification of Multiplex Nucleic Acid Assays, Reference and Quality Control Materials section) recommends verifying assay performance with control material that is processed the same way as a patient specimen, extraction through detection, and CAP/CLIA accreditation checklists expect that same full-process verification with every new lot, shipment and instrument change. That standard holds up less and less against panels this complex, run at this scale. No control recovers a failure it was never built to test for, and by the time the gap shows up, it’s already a missed diagnosis.
What Happens Without Full-Process Verification
Synthetic controls enter at amplification, so a lysis or extraction failure still passes QC. The one failure you needed to catch is exactly the one it can’t see.
Frozen or pellet-format controls risk degraded nucleic acids and inconsistent potency before they ever touch the workflow. Your control can fail before your sample ever does.
Testing each target separately burns reagent and instrument time that a pooled, single-vial control avoids. QC ends up costing more than the assay it’s supposed to be checking.
Reconstituted or multi-use formats add handling steps a single-use vial doesn’t have. Every extra step is one more chance for the control itself to be the thing that fails.
Signs You Need Full-Process QC
If any of these are true, you already need full-process QC. The earlier a gap is caught, the less it costs to fix.
Frozen and pellet formats add cold-chain risk to the one thing that’s supposed to stay constant. Room-temperature controls remove that dependency entirely.
Built for Your Workflow
Your QC should fit the workflow you already run, not force you to build a new one around it.
No Freezing
Room temperature, ready to use. No freezer, no thaw window, no potency check before you can run it.
No Retraining
Handled exactly like a patient sample, using the technique your team already knows.
No Extra Documentation
One barcode, one Control ID. Nothing separate to log.
No New Equipment
Loads onto the system you already run, verified alongside every other cartridge.
A missed diagnosis is the predictable cost of running the same control out of habit. Catch the failure at QC — not on a patient sample.
A Control Purpose-Built for Every Test
Blood culture identification, respiratory panels and STI/women’s health, from FDA-cleared clinical controls to Research Use Only controls for assay development.
Blood Culture Identification
Sepsis & bloodstream infection panels
IVD · FDA Class II Cleared
MDx-Chex® for BCID2
Full-process control covering all 43 BCID2 bacteria, yeast and AMR gene targets for the BIOFIRE® BCID2 Panel.
IVD · FDA Class II Cleared
MDx-Chex® for BCN
Full-process control for the LIAISON PLEX® Gram-Negative Blood Culture Assay, from lysis and extraction through detection.
IVD · FDA Class II Cleared
MDx-Chex® for BCP
Full-process molecular quality control designed for comprehensive validation of the LIAISON PLEX Gram-Positive Blood Culture Assay.
IVD · FDA Class II Cleared
MDx-Chex® for BCY
Full-process molecular quality control designed for comprehensive validation of the LIAISON PLEX Yeast Blood Culture Assay.
IVD · FDA Class II Cleared
MDx-Chex® for BC-GP
Full-process molecular quality control designed for comprehensive validation of the LIAISON PLEX Yeast Blood Culture Assay.
IVD · FDA Class II Cleared
MDx-Chex® for BC-GN
Full-process control designed to validate the entire analytical process of the Luminex VERIGENE BC-GP Panel for sepsis testing.
Respiratory
High-plex syndromic & assay-development panels
Research Use Only
MDx-Chex® for RP
Full-process control spanning 24 viral and bacterial targets for high-plex respiratory panels.
Research Use Only
MDx-Chex® for RLP
Platform-agnostic control covering Influenza A/B, RSV, rhinovirus, SARS-CoV-2 and Group A Strep.
STI & Women’s Health
Sexual health & vaginitis panels
Research Use Only
MDx-Chex® for CT/NG/TV
Pooled full-process control for chlamydia, gonorrhea and trichomoniasis assays in a single formulation.
Research Use Only
MDx-Chex® for MVP
Full-process control for bacterial vaginosis, the Candida group and T. vaginalis.
54+
years of scientific
excellence
Zero
FDA recalls
70,000+
labs worldwide rely on
Streck products
ISO 13485
certified manufacturing
Build Your Control Alongside Your Assay
Don’t wait until your panel launches to find out your QC doesn’t fit it. Streck brings decades of stabilization technology to control co-development, offering regulatory support, stability validation and custom formulations built around your platform from the start.
The Science of Trust®
Find the Right Control for Your Panel
Stop settling for a control that only checks the last step. Talk to a Streck molecular diagnostics specialist or explore the full portfolio matched to your platform, panel and regulatory pathway.
Some Streck products are for Research Use Only. Please refer to individual product pages for details.
