POC KIT, VITAMIN D - FINECARE

The Finecare™ Vitamin D Rapid Quantitative Test along with Finecare™ FIA Meter is a fluorescence immunoassay quantitative determination of total 25(OH) D2/D3 level in human serum or plasma. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency.

For in vitro diagnostic use only. For professional use only.

STORAGE AND STABILITY 

1. Store at 4°C～30°C up to the expiration date.

2. The solid marker bottle can be stored at 2°C～8°C for 28 days after being reconstituted

3. Do not remove the device from the pouch until ready to use. The Test Cartridges should be used within 1 hour once opened.

SPECIMEN PREPARATION 

The test can be performed with serum or plasma:

1. Following standard phlebotomy procedure, collect a venipuncture whole blood specimen using a blood collection tube. If collection plasma, use a blood collection tube containing suitable anticoagulant (Heparin，lithium heparin orsodium citrate is recommended).
2. Separate the serum/plasma from blood as soon as possible to avoid hemolysis.
3. Test should be performed immediately after the specimens have been collected. Do not leave the specimens at room temperature for prolonged period. Specimens may be stored at 2°C～8°C for up to 4 days. For long-term storage, specimens should be kept below -20°C .

Note:
1) Frozen plasma or serum must be rapidly thawed to reach room temperature then mixed thoroughly before use.
2) No more than a single freeze/thaw cycle is recommended. Clotted or severely hemolytic specimens are not suitable for testing and shall be rejected. Another specimen should be obtained and tested.