Storage method of apolipoprotein C2 assay kit

The ApoC2 assay kit is an in vitro diagnostic reagent used to detect the content of ApoC2 in serum or plasma, and its stability directly affects the accuracy of the test results. The storage of reagent kits requires comprehensive consideration of component characteristics (such as enzymes, antibodies, buffer solutions, etc.), environmental factors (temperature, humidity, light), and packaging integrity. The following are specific storage methods and precautions:

I. Core storage conditions

Temperature control

Unopened reagent kits:

Recommended temperature: 2-8 ℃ (refrigerated), avoiding freezing (especially for reagents containing enzymes or antibodies, freezing may cause protein denaturation or loss of activity).

Special ingredient reagents:

If the reagent kit contains antibodies used for immunoturbidimetry (such as anti-ApoC2 monoclonal antibodies), it should be strictly refrigerated to prevent antibody degradation;

; If it contains chemical colorants (such as peroxidase substrates), it should be refrigerated in the dark to prevent the decomposition of colorants.

After opening:

Short term use (≤ 1 month): can continue to be refrigerated, but it needs to be sealed and moisture-proof;

;

Long term packaging: If multiple uses are required, it is recommended to package according to a single dose and freeze (below -20 ℃) to avoid repeated freezing and thawing (freezing and thawing times ≤ 3 times, otherwise it may affect the activity of the reagent).

.

Light Avoidance Requirements

The photosensitive components (such as fluorescent markers and certain chromogenic substrates) in the reagent kit should be stored in the dark and can be wrapped in aluminum foil or stored in opaque containers.

;

When refrigerating, avoid direct exposure to fluorescent lamps or strong light to prevent component decomposition from causing an increase in background values or a decrease in sensitivity.

.

Humidity control

The relative humidity (RH) should be controlled between 30% and 70% to avoid moisture absorption or agglomeration of reagents;

; If the reagent kit contains desiccants (such as silica gel particles), the status of the desiccants should be checked regularly (discoloration indicates failure), and they should be replaced or sealed for storage after failure.

2. Packaging and Usage Guidelines

Packaging Operation

Aseptic Operation: Packaging should be done in an ultra clean workbench or biosafety cabinet to avoid contamination;

;

Container selection: Use centrifuge tubes or reagent bottles made of polypropylene (PP) or polyethylene (PE) material, and avoid using glass containers (which may release alkaline substances and affect pH stability);

; Clear labeling: After packaging, label the reagent name, concentration, packaging date, and expiration date for easy traceability.

Preparation before use

Requirements for reheating: The refrigerated reagent should be equilibrated to room temperature (20-25 ℃, about 30 minutes) before use to avoid instability of the reaction system caused by low temperature;

;

Mixing steps: Gently invert or vortex before use to prevent component precipitation (especially for reagents containing particles, such as latex enhanced immunoturbidimetric reagents).

.

III. Stability Monitoring and Validity Period Management

Stability Testing

Accelerated Aging Test: Some test kits will indicate the stability of the opened bottle (if valid within 30 days after opening), which needs to be verified through experiments (such as storing the reagent at 37 ℃ for 7 days to test whether the performance meets the standard);

; Real time stability monitoring: Regularly test the blank absorbance, sensitivity, linear range and other indicators of the reagent, compare them with the initial value, and replace the reagent if the deviation exceeds 10%.

Expiration date management

Unopened reagent kit: The expiration date is usually 12-24 months (based on the production date or batch number), and it should be used within the expiration date;

;

After opening, the validity period of the reagent is shortened to 1-3 months (please refer to the instructions for details), and the earlier opened reagent should be used first.

.

IV. Special Scenario Handling

Transportation Process

Cold Chain Transportation: Use ice packs and insulated boxes (2-8 ℃) or dry ice (below -20 ℃) for transportation to avoid temperature fluctuations exceeding ± 2 ℃;

;

Seismic measures: The reagent kit should be fixed inside the transport box to prevent severe vibration from causing reagent leakage or container damage.

.

Power outage or equipment failure

Short term power outage (<4 hours): Refrigerated reagents can be temporarily stored in an insulated box to avoid frequent opening and closing of the refrigerator door;

; Long term power outage (>4 hours): Reagents need to be transferred to backup refrigeration equipment or contact suppliers for emergency storage plans.