BIOSITE PROCEDURE:
SAMPLE COLLECTION AND PREPARATION:
Whole blood or plasma using EDTA as the anticoagulant is the specimen required for testing with this product. Blood will be obtained at the time of beginning an intravenous drip or with a venipuncture per current policy/procedure methods.
EMS personnel will draw a purple top along with other necessary blood tubes.
PROCEDURE:
· The specimen and device must be at room temperature.
· Mix the blood specimen by gently inverting the tube several times before transferring blood to the Test Device.
Label specimen
Open the pouch, write the patient first & last name on the label of the Test Device along with the time the cartridge was opened. Obtain sample from the purple-top EDTA - anti-coagulated whole blood that is identified on the tube with the patient’s first and last name, date-of-birth, and last 4-digits of SS# (if available).
Inoculate the cartridge just before arrival at the facility. Keep the specimen flat until the absorption chamber is empty (approximately one minute).
Using the Transfer Pipette
· Depress the larger (top) bulb completely and insert the tip into the specimen.
· Release the bulb slowly. The tube should fill completely. Some fluid must remain in the smaller (lower) bulb.
· Place the tip of the pipette into the sample port of the Test Device and depress larger bulb completely. The entire amount of sample in the pipette tube must be dispensed. The sample in the smaller (lower) bulb will not be expelled.
· Remove the tip from the sample port and then release the bulb.
· Discard the transfer pipette.
Keep the Test Device flat until sample absorbs into the filter. (Testing begins once the sample comes in contact with the reagent on the cartridge).
Upon arrival to the ED. Give the cartridge and blood tubes to the nurse during report and verify patient ID.
Retrieve a new cartridge and label for storage in preparation for the next cardiac event.
-Lab will prepare labels that will identify the cartridge as property of Conroe, with a place to write the lot number and expiration date. A secondary label will be attached that can be used to label the purple top blood tube.
STORAGE AND HANDLING REQUIREMENTS:
· The lot number on the pouch must correspond with the machine at hospital.
It is best to rotate pouch back to facility every 14 days to keep in sync with current lots.
The Triage Cardio ProfilER Test Device is stable (while in the sealed pouch) up to the expiration date when stored refrigerated at 2° - 8°C (35° - 46°F).
o The ED will house the devices in a refrigerator with controlled temperature that is checked daily per Joint Commission guidelines.
o The device should be stored with the blood draw kits in interior shelf Q.
· Once removed from refrigeration, the pouched Triage Cardio ProfilER Test Device is stable for up to 14 days, but not beyond the expiration date printed on the pouch.
o Be aware of extreme temperature. If the truck has controlled temperature in the back the devices can be kept at room temperature. However, refrigeration is recommended to increase the life of the device.
o NOTE: extreme heat and humidity can affect the test device and lead to measurement failure. Avoid carrying the device in pockets.
· If not used on the same day of removal from refrigeration, gently write the date of removal from the refrigerator and the date to discard on the foil pouch and/or the kit box (use a soft, felt tip marker).
WARNINGS AND PRECAUTIONS
· For In Vitro Diagnostic Use.
· For use by healthcare professionals.
· Do not use the kit beyond the expiration date printed on the outside of the box.
· Keep the Test Device in the sealed pouch until ready to use. Discard after single use.
· The transfer pipette should be used for one specimen only. Discard after single use.
· Patient specimens, used Test Devices and transfer pipettes may be potentially infectious. Proper handling and disposal methods should be established by the laboratory director in accordance with local, state and federal regulations.
· Proper laboratory safety techniques should be followed at all times when working with blood specimens because they are potentially infectious.
· The Triage Cardio ProfilER Panel should not be used as absolute evidence for AMI or CHF. As with all in vitro diagnostic tests, the test results should be interpreted by the physician in conjunction with clinical findings and other test results.
· Blood concentrations of BNP may be elevated in patients who are experiencing a heart attack, patients that are candidates for renal dialysis, and patients that have had renal dialysis.
· Carefully follow the instructions and procedures described in this insert.
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Biosite Procedure
Revised February 2010