Biospecimen Collection Instructions

Transcription

1 Biospecimen Collection Instructions Thank you in advance for your participation! In addition to your important contribution to research, we will provide you with the results of your HbA1C test. HbA1C is a valuable measure that has been recommended by the American Diabetes Association for the screening of type 2 diabetes as well as to evaluate glucose control for individuals who have already developed diabetes. In addition to the lab result, you will be provided with an interpretation of the result and clinical guidance from one of the Diabetes & Women s Health Study physicians If you have any questions, feel free to: us: nhs2dwh@channing.harvard.edu or Call us: For answers to frequently asked questions, visit our website at Our office hours are Monday through Friday, EST 8:00 A.M. 5:00 P.M. We remain on call during off hours and make our best effort to respond to urgent calls within the same business day. Please leave a voic . If at any point you decide not to participate, please call us before discarding your kit. 0

2 Thank you for your contribution of time, energy, and samples to the Diabetes and Women s Health Biospecimen Collection Project! Before you proceed, please confirm that the NHS alias ID on your blood and urine tube labels match the NHS alias on your packet envelope. If they do not, contact us immediately. I. Forms a. 1 Biospecimen Collection Instruction Form b. 1 Research Consent Form c. 1 Medical Record Release Form Kit Contents d. 1 Blood and Urine Collection Questionnaire e. 1 Toenail Collection Questionnaire II. Blood Collection Supplies (see figures of blood collection tubes on the blood collection instruction sheet, the tube number for the figure is in parentheses) a. 1 10mL red top tube (1) b. 1 2mL EDTA lavender top tube (2) c. 1 10mL EDTA lavender top tube (3) d mL PAXgene tube (4 and 5) e. 1 pair of gloves f. 1 Alcohol wipe g. 1 Butterfly Needle h. 1 Tourniquet i. 1 Band Aid j. 1 Tube Holder k. 1 Gauze Pad III. Urine Collection Supplies a. 1 4oz. urine collection cup b. 1 towelette IV. Toenail Collection Supplies a. 1 Toenail Clipper (6) b mL cryovial (6) V. Shipping Supplies a. 3 95kPa Specimen Transport Bag with Absorbent Material b. 1 FedEx Return Airway Bill c. 1 gel pack d. 1 Kraft envelope 1

3 Please plan to collect and ship your samples Monday through Thursday. Our capability to receive and process samples on Saturdays and Sundays is limited. Please also note: FedEx does not pick up on Saturday, Sunday, or national holidays. If you need to collect your samples during the weekend: Put the sample in the refrigerator (do not freeze) and send it on Monday morning. If you do this, include a note with your samples so we are aware of the weekend draw date. Note: for Paxgene RNA tubes with blood, please store at room temperature for a minimum of 2 hours (preferably 2 4 hours) before placing in the refrigerator. To confirm that you are willing to participate in the study: We have provided a Research Consent Form. This form explains the procedures involved in the study, potential risks and benefits to you, and information about confidentiality. It is essential that you sign and date the consent statement at the end of the form and return the entire form with your samples. 1 2 days before you plan to have your blood drawn: CALL PHLEBOTOMIST If you are having your blood drawn at a lab or doctor s office, call ahead of time to confirm that they will draw blood for someone in a research study. Community health centers may be willing to do the draw; you may search for your local center at the website FREEZE GEL PACKS Put the refrigerant gel packs into the freezer overnight. CALL FEDEX Call FedEx to arrange for FedEx pickup. They can pick up from your home or work. Call (1 800 GO FEDEX) and dial 0 to speak with an operator. Tell the operator that you are shipping via Priority Overnight method using a billable stamp and give them the address where you would like the pick up to be made. You may also drop off your parcel at a manned FedEx location, which can be found by calling FedEx or visiting You do not need to make prior arrangements to drop off your samples. 2

4 The day before your blood draw: Eat a small meal just before 10 PM. Following the small meal, if your health permits, we recommend you not to eat, drink (except water) or be physically active from 10 PM the day before having your blood drawn (fasting for 9-10 hours). If you are on glucose regulating medicines, you can continue with the medicine until the night before the examination. However, from that evening forward we recommend that you abstain from taking your glucose lower medicine until after the blood draw. You can take their medicine after the blood samples are taken. Toenail Collection To avoid interference with the timely collection of blood and urine samples, we ask that you collect your toenail clippings before collecting the rest of the biospecimens. Please do not trim your toenails for at least 2 weeks. All the material needed for the toenail collection can be found in the toenail collection bag. Use the stainless steel clipper provided to clip all 10 toes. Try to obtain as much toenail from each toe as possible. Collect your clippings in the 1.8mL toenail cryovial. (Figure 6) Place the cryovial in the toenail collection bag then place the bag in the shipping box. * If you forget to grow your toenails before collecting blood and urine samples, use the toenail collection envelope for a separate toenail collection. Call the study staff at NHSII to coordinate a separate mailing of toenail samples. After collecting toenail clippings, place them in the toenail cryovial and place the cryovial in the toenail collection envelope with a completed toenail collection form. Mail this envelope using the prepaid airbill. On the day of blood draw and shipment: We recommended that your urine sample is a first morning void. If you forget to collect a first morning urine, a sample collected later in the day also is valuable. URINE COLLECTION 1. COLLECT FIRST MORNING URINE SAMPLE Use the enclosed plastic specimen cup. Use the Castile towelette to wash before collecting the sample. 2. STORE THE SAMPLE Place the specimen cup in the refrigerator (face up) until you are ready to collect your blood samples. 3

5 BLOOD DRAW Time of day to collect blood and urine samples: We would prefer you to have your blood drawn in the morning before you eat or drink (you can drink water). 3. TAKE SUPPLIES Put the frozen refrigerant pack into the Styrofoam box and bring the entire cardboard box with you when you go to have your blood drawn. If you are planning to ship immediately after having your blood drawn, also take your urine. 4. BLOOD DRAW All supplies needed to draw your blood samples are in the blood collection bag in your kit. Specific blood collection instructions can be found on the last page. If you have your blood drawn by a phlebotomist, please hand them the blood collection instruction sheet (the final page of this packet). 5. PACK UP BLOOD TUBES Place the 2 lavender top and 1 red top tubes (see pictures) into a blood collection bag with the absorbent material. There will be a small collapsed paper tube holder in the blood collection material. Assemble tube holder to form a small rectangular box with two holes are on the top face of the box. All other contents in the blood bag will have been used during the blood draw. Place the PAXgene tubes (see pictures) in the tube holder. Please let the PAXgene tube remain upright at room temperature for 2 4 hours before packing. Place the PAXgene tube holder in another collection bag with absorbent material. Place the tubes in the shipping box to keep them cool until you are ready to finish packing your kit. Be careful not to let the tubes touch the cold gel pack directly. If you are charged for the blood draw, have the laboratory bill the Nurses Health Study II directly using the reimbursement form included in the kit, or send us a copy of your paid bill for reimbursement using the same form. Please remember to include the receipt. Most charges for blood draw services range from $5 $30. PREPARING BLOOD, URINE, AND TOENAIL SAMPLES FOR SHIPMENT: Once you have collected your blood, urine, and toenail samples, pack your kit for shipping. 1. Sign and date the Research Consent Form if you haven t done so already. 2. Complete the blood and urine collection questionnaire and the toenail collection questionnaire. 3. Place the questionnaires and the consent form into the Kraft envelope and seal. (If it is necessary, also include your reimbursement form). 4. If you have not done so already, place the 2 lavender top and 1 red top tubes into a clear blood collection bag with absorbent material. Place the tube holder holding your blood tubes into another clear blood collection bag with absorbent material. Also place your container of urine into the urine collection bag with absorbent material. Seal the bags. Make sure the box remains upright throughout packing. 4

6 5. Place the packed bags from step 4 and the toenail collection bag with vial into the shipping box on top of the gel pack. 6. Place the envelope containing the questionnaire and consent form on top of the biospecimen samples. 7. Seal the shipping box closed. 8. Write your name and address on the blank lines of the prepaid FedEx airway bill. Other fields have already been filled in. Adhere the airway bill to the box. 9. Give the package to the FedEx driver if you have arranged for a pickup, or drop it off at a FedEx location. FedEx has approved this packaging for the shipment of blood, urine, and toenails. Checklist: Not to cut toenails for at least 2 weeks before collecting toenail samples Collect toenail samples prior to collecting your blood and urine samples (page2). If you forget to allow toenail to grow for 2 weeks before cutting them and collect blood and urine prior to collect toenail, please mail the blood and urine samples in the box provided to you. Keep the toenail collection envelope to mail your toenail samples and toenail collection form separately. Call study staff for an arrangement of shipment of toenail samples later. Plan to collect and send blood and urine samples on Monday Thursday. (page 1) Review and sign the Research Consent Form (page 1) Call the lab or doctor s office where you will have your blood drawn to confirm they will draw blood for a research study (page 1) Call FedEx ( ) to arrange for package pick up the day before collection (page 1) Put the refrigerant gel back in the freezer the day before collection (page 1) Collect urine sample from first morning void on same day as blood draw (page 2) Bring all supplies and urine with you to the blood draw. (page 2) Complete the questionnaires (page 3) Pack the shipping box for return shipment (page 3 & 4) IF YOU HAVE ANY QUESTIONS OR NEED MORE SUPPLIES, E mail us at nhs2dwh@channing.harvard.edu or call us at Again, for answers to frequently asked questions, visit our website at THANK YOU! 5

7 Blood Collection Instruction Sheet Please have participant sit and rest for 10 minutes to allow body fluid shifts to equilibrate. Blood should be drawn from the antecubital vein. Please fill tubes in the following order, as seen in the picture from left to right: 1st: 10 ml red top tube with 8 ml blood 2nd: 2 ml lavender top tube with 2 ml blood 3rd: 10 ml lavender top tube with 10 ml blood 4th: 2.5 ml PAXgene RNA tube 1 (NOTE: the PAXgene tubes have liquid in the tube) 5th: 2.5 ml PAXgene RNA tube 2 To use the butterfly needle, remove the clear cap. Once the needle is in the vein, push the 10mL red top tube into the clear needle holder until the tube stopper is punctured and blood starts to flow. Once the tube is full, remove it carefully, and gently insert the 2mL lavender top tube into the holder. Repeat this for the 10mL lavender top tube and please make sure the 2 PAXgene tubes are drawn last Immediately after filling each tube, invert it times to prevent the blood from clotting o For the PAXgene tubes, please allow at least 10 seconds for a complete blood draw to take place and ensure that the blood has stopped flowing into the tube before removing the tube from the holder o When collecting blood using PAXgene TM RNA tube, hold the tube vertically below the participant s arm to avoid possible backflow from the tube; allow at least 10 seconds for a complete blood draw to take place, and ensure that the blood has stopped flowing into the tube before removing the tube from the holder. o The PAXgene tube must remain upright at room temperature for at least 2 hours (preferably 2 4 hours) prior to being packed with the ice packs or put in a refrigerator. 6