What can affect the shelf life of an ELISA kit?

storage Conditional factors

Temperature anomalies: Failure to store at 2–8 °C as required, resulting in freezing (≤0 °C) or prolonged exposure to high temperatures (≥30 °C), will directly lead to enzyme, antibody and other active protein to denature and lose their activity; the structure of pre-coated microplates may also be damaged, significantly shortening the shelf life.

Repeated freeze-thaw ‌: kit within standard, enzyme complexes and other components, if subjected to repeated freeze-thaw, will result in the disruption of the protein spatial conformation and irreversible loss of activity, leading to a failure in performance well before the labelled expiry date.

Excessive light and humidity: Prolonged exposure to direct sunlight or intense light may degrade the activity of fluorescent labels and TMB substrates; high humidity may cause the kit to become damp, compromise the integrity of the reagent seals, accelerate the deterioration of components and affect the validity of the quality assurance.

Transport and operational factors

Failure of the cold chain: During transport, ice packs may melt or the product may be exposed to high temperatures for prolonged periods; kit this can lead to a decline in potency before the stated expiry date, thereby falling outside the scope of the warranty.

Improper handling after opening: Failure to store the product in a sealed container after opening, failure to use up the liquid reagent within one month, or continued use of the reagent after it has become cloudy, developed a precipitate or undergone abnormal colour changes will rapidly degrade the reagent’s performance, rendering it no longer compliant with the manufacturer’s quality assurance requirements.

specimen Cross-contamination: During the experiment, specimen and consumables introduce exogenous contaminants, causing reagents to become contaminated or deteriorate; such issues arising from human error are not covered by the manufacturer’s warranty.

Components and intrinsic properties

Differences in component stability: enzyme Conjugates, biotin-labelled antibody and lyophilised standard components, amongst others, are inherently unstable and have shorter chemical half-lives; they are therefore more prone to loss of activity than other components and are key factors influencing the overall duration of quality assurance.

Quality control deviations in batch production: Products that have not been subject to ISO 13485 system controls, lack complete batch Certificate of Analysis (COA) documentation kit, have inter-batch CV values exceeding the specified limits, and exhibit insufficient stability upon release; such products are also prone to performance fluctuations during their shelf life.

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Note: The information on the scientific research products above is for reference only!