GMDN TERM

Red cell antibody diluent IVD, reagent

INTENDED USE

Whole Blood Collection Kit is a single-use device intended to be used by healthcare professionals and researchers to collect finger-prick whole blood samples.

DEVICE CHARACTERISTICS

Whole Blood Collection Kit is designed to collect capillary blood samples for analysis by healthcare professionals and researchers. The lancet is used to produce a small skin piercing, usually on the fingertip . Use the capillary sampler to transfer blood to the buffer solution for further analysis.Caution: The suitability of the kit for any analytical application must be evaluated and validated by the analytical laboratory.

MATERIALS PROVIDED

EQUIPMENT AND MATERIALS REQUIRED NOT PROVIDED

• Sharps disposal container.
• Personal protective equipment (PPE): gloves and other PPE as required to protect from exposure to blood-borne pathogens.

PROCEDURE

1. Wear gloves and remove device(s) from packaging.
2. Wash patient hands and sterilise finger with a disinfectant wipe.
3. Prick fingertip with the lancet and gently press finger to produce blood.
4. Use capillary sampler to collect blood sample.
5. Add the sample into buffer solution, shake sample to mix.
6. Clean wound with cotton swab and cover with band-aid.
7. Follow applicable instructions for downstream analysis.

DOWNSTREAM ANALYSIS

• Analysis should be performed by qualified laboratories using validated protocols.
• No protocols are specified for sample preparation and downstream analysis.
• Clinical laboratories must qualify the validity and safety of protocols used for any particular laboratory assay, and establish the reference range for a specific instrument. Adequate calibration and standard controls for the assay being undertaken should be applied.

DEVICE STORAGE AND HANDLING

• Unopened devices can be stored from 4°C to 25°Cprotected from moisture and sunlight until the expirationdate marked on the device.
• Opened devices should be used immediately.

PERFORMANCE CHARACTERISTICS

The kit is designed for the collection of human whole blood.

WARNINGS AND PRECAUTIONS