Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomised, placebo-controlled ...
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Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomised, placebo- controlled prophylaxis study UK Sample Management v3.0, 2nd July 2020
Laboratory Testing & Sample Processing Clotted Capillary TNS EDTA (Throat and Sputum* Blood blood Nose Swab) Plasma Serum PK-DBS Cell pellet PK-DBS * At this time we are not collecting sputum. You will be informed in future if this situation changes. V3.0, 02 July 2020 2
Sample Management: This is a screenshot of the sample management system we are using, OpenSpecimen. You will be granted access to this system. It allows us to track the location and number of samples, as well as the dates of collection and other essential data. If you have any specific queries about this system that aren’t covered in the training manual then please contact the central trial team. V3.0, 02 July 2020 5
Sample Management (Cont.) When you start typing a participant’s ID in the top menu bar it will allow you to click on the participant. V3.0, 02 July 2020 6
Sample Management (Cont.) This page provides access to each collection time point, and you just press collect to start this process. V3.0, 02 July 2020 7
Sample Management (Cont.) This screen allows you to fill in all the necessary information, as well as complete the blood collection data entry in OpenSpecimen. V3.0, 02 July 2020 8
Sample Management (Cont.) This slide shows how to enter a sample’s location in the storage box. V3.0, 02 July 2020 9
Labelling This is a picture of the labels you will be sent; they contain a round sticker to be placed on the top of the tube and a rectangular one to be placed around the side. These are pre-printed so all you need to do is affix them. V3.0, 02 July 2020 10
Plasma, cell pellet, serum processing Invert 6-8 times before 3 vials EDTA processing 0.5 mL plasma (store at 4°C) 1 vial 0.5 mL buffy 1,500 rcf, coat Immediate 10 minutes, Freeze Serum 25 °C At < -80 °C tube No brake 3 vials (room 1 mL serum temp for 30 mins) V3.0, 02 July 2020 11
DBS on 31 ET Chr paper for CQ level Sample Label 100 µL from EDTA tube BEFORE spin (D0) • 1 DBS/Bag Air dry 50 µL / spot 6 hr - o/n • Keep in cool , dry place Finger • Attach circular prick No sticker to top (D30, D60, D90) hair right, below dryer!! seal V3.0, 02 July 2020 12
Example for ‘Good’ and ‘Bad’ Quality DBS V3.0, 02 July 2020 13
SHIPMENTS • 2 - 5 batches (depends on site facilities, number of samples, etc). • Shipments will be pre-paid for with Davies International, and samples can be transported 12 or 26 boxes at a time. • When a collection is requested, a polystyrene box – already filled with dry ice – will be sent to sites for arrival on a Tuesday. Sites will then fill the box, and it will be collected on the same Tuesday for delivery to Oxford (DTU/OCDEM) on Wednesday. • Sample log data must be sent to the central trial team once shipment organized. • Davies Int. will apply all the appropriate stickers to the boxes, eg UN3373, UN1845 etc. V3.0, 02 July 2020 14
Additional Information Reference Documents: • COPCOV UK Protocol • COPCOV UK Lab Guidelines and SOP Always refer to www.copcov.org/sites for correct version of documents If you have any further questions please contact copcov@dtu.ox.ac.uk V3.0, 02 July 2020 15
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