Table 3. Tier 1 biospecimen collection and processing summary.
| Collected Specimen | Quantity | Biobanked Specimen Type | Number of Aliquots | Aliquot Volume | Processing |
|---|---|---|---|---|---|
| Nasopharyngeal or nasal swab* | 1 | Nasal Cells | NA | 1 | Processed locally within 1 hour; frozen to -90°C to -65°C; batch shipped on dry ice |
| Blood in serum separator tube | 2 x 8.5 ml | Serum | 10 | 1 ml | |
| Blood in cell preparation tube (CPT)** | 4 x 8 ml | Peripheral Blood Mononuclear Cells (PBMCs) | 8 x PBMCs (target cell count minimum 5 million cells/mL) | 1 ml | Centrifuged locally, refrigerated, shipped at refrigerated temperature on day of collection |
| Blood in sodium citrate tube** | 2 x 2.7 ml | Plasma | 2 | 1 ml | Processed locally within 1 hour; frozen to -90°C to -65°C; batch shipped on dry ice |
| Blood in ethylenediaminetetraacetic acid (EDTA) tube** | 1 x 10 ml | Plasma White blood cells*** |
4 1 |
1 ml | Refrigerated, shipped at refrigerated temperature on day of collection |
| Blood in PAXgene-RNA tube | 1 x 2.5 ml | Whole blood | 1 | 2.5 ml | |
| Urine in no additive tube | 1 x 10 ml | Urine supernatant | 8 | 1 ml | |
| Saliva in Oragene OGR-600*** | 1 x 2 ml | Saliva | 1 | 2 ml | |
| Stool | 1 x 25 ml | Stool | 1 | 25 ml | Directly sent by participant |
* As of June 29, 2022, nasopharyngeal swab changed to nasal swab
** As of protocol v6.0, added sodium citrate and EDTA tubes and CPT reduced to 2 cell preparation tubes.
*** Not collected in those who decline genetic testing