Stability & Shelf Life
What it is
Confirming a test performs consistently across its labeled shelf life and storage range.
How it works
Real-time and accelerated stability studies validate performance at temperature and humidity extremes before shelf life is assigned.
Why it matters
Stability data underpins the labeled shelf life and the no-cold-chain advantage of colloidal-gold tests.
Key components
- Real-time stability
- Accelerated aging
- Temperature and humidity stress
Applications
- Confirming performance across the labeled shelf life
- Supporting no-cold-chain claims
What affects performance
- Temperature and humidity stress
- Real-time vs accelerated aging
- Reagent degradation
Limitations
- Accelerated aging predicts but does not replace real-time data
- Stability is formulation-dependent
Common failure modes
- Reagent degradation at temperature extremes
- Humidity damage to membranes
- Performance drift before expiry
Frequently Asked Questions
What is stability testing? Confirming a test performs consistently across its storage range and shelf life.
What is accelerated aging? Elevated-temperature storage that predicts shelf life faster than real-time testing.
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