SITE PROCEDURES NASAL SWAB

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1 SITE PROCEDURES NASAL SWAB Nasal Swab Collection Nasal swab specimen labels EXAKT-PAK One Pak shipping system Cryogenic specimen vial with transport medium Outer transport tube with absorbent material Copan Pediatric FLOQ-Swab 1. Note that the index nasal swab specimen cannot be taken less than 2 hours after the NPA specimen 2. Wash your hands before taking swab 3. Tilt child s head back gently, with one hand to steady chin 4. With the other hand, insert the end of a new swab into the front part of one of the nostrils 5. Rub swab gently against the inner wall of the nostril, whilst getting a good sample of mucus if child has a runny nose at the time 6. Remove the swab from the nostril, and using the same swab collect a swab from the other nostril 7. Remove cap from specimen vial with transport medium 8. Put the swab in the transport medium and break the shaft at the molded breakpoint. 9. Close the vial cap securely 10. Remove the cap from the outer transport tube 11. Pull up and separate the two ends of the absorbent material 12. Insert the sealed specimen vial UPRIGHT into the plastic container inside the absorbent material folds 13. Use your finger to gently push the vial fully into the container cavity. 14. Tuck in any excess absorbent material, keeping the ends within easy reach 15. Screw the cap on tightly 16. For site only: [Ensure the parent/legal guardian witnesses and understands the collection procedure so he or she can repeat the procedure for all follow-up nasal swab collections] Labeling Sample Nasal Swab Label 1. Verify the Study ID is correct, write the date (mm/dd/yr) and time (hh:mm) of sample collection on the label. 2. Place Sample Nasal Swab Label on the cryogenic vial. 3. Wrap a strip of clear tape around the whole tube, over the label, and atop itself to prevent the label from falling off. 4. Record the date (mm/dd/yr) and time (hh:mm) of sample collection in the Specimen/Enrollment Checklist in REDCap.

2 5. Place the container in the outer cardboard box 6. Fold the flaps over to cover the container. Close the lid. It is NOT necessary to tape the box. Storage The nasal swab specimens will not be stored at the enrolling hospital. They will be shipped as soon as they are collected. Shipping Note: Study personnel who package the nasal swab shipments do not need to have IATA certification and the packages do not need to have biohazard labels since the shipments will meet all criteria to be classified as exempt human specimens. Ship all nasal swab specimens collected during enrollment directly to the Massachusetts General Hospital using the provided pre-addressed, pre-paid, outer box via first class mail. Nasal swab specimens will be shipped to: Carlos A. Camargo, M.D. Attention: Ashley Sullivan Massachusetts General Hospital 326 Cambridge Street, Suite 410 Boston, MA Tel: After shipment, all sites should record date shipped in the Nasal Swab section of the Specimen/Enrollment Checklist. PARENT/LEGAL GUARDIAN PROCEDURES NASAL SWAB All collection and shipment procedures are identical to site procedures. All collections materials used by the parents will have labels pre-affixed by study personnel at either the enrolling site or the EMNet Coordinating Center.

3 MASSACHUSETTS GENERAL HOSPITAL (MGH) PROCEDURES NASAL SWABS Storage All specimens stored at MGH will be labeled with a bar code upon arrival. The nasal swab specimens will be stored at 80 o C for 0-6 months at MGH. Three times per year Massachusetts General Hospital will then ship all received specimens to the Baylor Laboratory Shipping of Nasal Swabs from MGH to Baylor Note: Only lab personnel with IATA certification may package and ship the nasal swab specimens to Baylor Laboratory because the shipment involves dry ice. The study coordinator should be present during this process to ensure that all nasal swab specimens are included in the mailing, to give the necessary supplies to the person preparing the package, and to include the completed shipment list in the mailing. Specimens will be shipped three times during each study year (in February, June, and October) until all follow-up nasal swab collections are complete. Mindful of holidays, specimens should be sent only on Mondays, Tuesdays, or Wednesdays so that the specimens do not arrive on a Saturday, Sunday, or holiday. Prior to shipment, the shipment list should be matched against the nasal swab specimen collection form in REDCap to ensure that all specimens are accounted for. Sterile gloves Biohazard bag(s) Absorbent material Nasal Swab Shipment List (completed) Envelope for Nasal Swab Shipment List 5 lbs (2.27 kgs) dry ice (small pellets rather than large blocks) Sample box Styrofoam box (to hold dry ice and sample box) Cardboard shipping box Biohazard sticker or biohazard bag (for top of Styrofoam box lid) Exempt Human Specimen label Dry Ice shipment label 1. Put on sterile gloves and remove samples from freezer. 2. Place each nasal sample in a biohazard bag, (only ONE sample per bag) with absorbent material, while noting on the Nasal Swab Shipment List their inclusion (At this time, the last column of the Shipment List should be completed). 3. Place the freezer bag(s) in sample box(es). 4. Add bubble wrap or foam padding around the bags for cushioning and put the lid on the sample box. 5. Place the sample box(es) the Styrofoam box.

4 6. Completely surround the box with samples with the 5 lbs (2.27 kgs) of dry ice. 7. Insert padding around the sample box(es) if there is additional space in the Styrofoam box. 8. Put lid on Styrofoam box and place into cardboard box. 9. Affix an orange biohazard sticker (or a bag that is pre-labeled with the universal biohazard symbol) to the Styrofoam box lid if one is not already present. 10. Put completed Nasal Swab Shipment List in an envelope and place on top of Styrofoam lid. Keep a copy of the Shipment List. 11. Seal cardboard box and affix the completed dry ice label. 12. On the FedEx label, be sure to check off Dry Ice and note the weight of dry ice. Also affix the Dry Ice label, which is required to be on the box and also notes the weight of the dry ice. 13. Attach Exempt Human Specimen label near the Dry Ice label. 14. Ship samples (overnight) to: Pedro A. Piedra, M.D. Attention: Kirtida Patel Baylor College of Medicine Department of Molecular Virology and Microbiology Mail stop code: BCM 280, Room 248E, One Baylor Plaza Houston, Texas Lab Tel: Office Tel: FedEx is the preferred carrier for frozen nasal swab specimen shipments to the Baylor Laboratory. On the day that the specimens are sent, MGH study personnel will ppiedra@bcm.tmc.edu the FedEx tracking number for the mailing.

5 SAMPLE NASAL SWAB SHIPMENT LIST Site # Sample ID# Date Collected (mm/dd/yr) Time Collected (hh:mm) Included in Shipment? **Please double-check that all samples are included in this shipment and that the sample box is surrounded by dry ice. **Please include this shipment list in mailing.

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