Correlation Study Steps:
1. Affix a label to each blood collection tube and check off the corresponding number on the Glycohemoglobin Data Collection Form.
2. Collect patient blood samples. Accuracy testing is best performed using fingerstick samples for A1CNow+ systems. Otherwise, samples should be fresh, whole blood preserved with Sodium or Lithium Heparin (green top tubes).1 If necessary, blood samples should be stored in the refrigerator (2-8ºC) and brought to room temperature and well-mixed before use. Blood samples should be run on the same day simultaneously when using multiple instruments at the site to avoid introducing additional variation.
3. Perform testing on a comparative method (in-office device or reference lab). Record results on your Glycohemoglobin Data Collection Form. Once completed, make a copy of the Glycohemoglobin Data Collection Form for your records.
4. Data can be calculated by PTS Diagnostics, if desired.
5. Send blood samples to an NGSP or IFCC certified lab.
a. Refrigerate all blood samples at 2-8ºC until ready for shipping. Ensure collection tube caps are secure.
b. Once sample collection is completed (or within 7 days of sample collection), place all samples into the specimen transport bag along with some absorbent material. Place the ice pack in the bottom of the cooler. Wrap the specimen bag with bubble wrap and place in cooler. The samples should not touch the ice pack. Place lid on the cooler and place cooler inside the shipping box.
c. Complete the Shipment Packing List and place on top of cooler. Securely close and tape the shipping box and affix pre-addressed FedEx label.
Within the United States:
d. Drop the box off at your local FedEx location or call FedEx to schedule a pick up (800-463-3339). NOTE: Samples must be shipped Monday through Thursday only; the laboratory is not open to receive samples on the weekends.
e. Ship to:
PTS Diagnostics
510 Oakmead Parkway
Sunnyvale, California 94085
(408) 524-2255
Attn: Charles Xie
Outside the United States:
f. NGSP or IFCC certified labs within your home country should be utilized.
http://www.ngsp.org/docs/labs.pdf