Quality Control
What it is
Lot-level testing against reference panels before release.
How it works
Each lot is tested for sensitivity, specificity and precision against known positive and negative samples; the internal control line validates each individual device.
Why it matters
QC ensures batch-to-batch consistency and catches failures before shipment.
Key components
- Reference panel testing
- Internal control line
- Sensitivity / specificity verification
Applications
- Lot-level testing against reference panels
- Verifying sensitivity, specificity and precision
- Internal control-line validation
What affects performance
- Reference panel quality
- Testing frequency per lot
- Control-line consistency
Limitations
- QC samples may not cover all real-world matrices
- Sampling cannot guarantee every device
Common failure modes
- Sampling gaps — QC samples may not cover all matrices
- Reference-panel mismatch
- Control-line inconsistency
Frequently Asked Questions
What is the internal control line for? It validates each device — distinguishing a true negative from a failed test.
Related knowledge
References
- Posthuma-Trumpie GA, Korf J, van Amerongen A. Lateral flow (immuno)assay: its strengths, weaknesses, opportunities and threats. Anal Bioanal Chem. 2009;393(2):569-582.
- 胶体金免疫层析法定性检测试剂技术审评要点（NMPA technical review）. ivdmat.com.
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Written by the Progene Bio Technical Team · Last reviewed: 2026-09-12