Table 2.
Saliva collection devices and respective manufacturers’ claims.
| Device | Abbreviation | Storage condition | Regulatory status |
|---|---|---|---|
| PAXgene Saliva Collector (769040) – (PreAnalytiX GmbH, Switzerland) | PreAnalytiX | Saliva collected and stabilized with the PAXgene Saliva Collector can be stored for DNA isolation for at least 24 months at temperatures up to 25 °C (study ongoing). In addition, PAXgene Saliva can be frozen long term at − 20 or − 80 °C when transferred into a suitable cryovial. SARS-CoV-2-derived RNA copy numbers are stabilized in saliva collected into PAXgene Saliva Collector for at least 4 days (96 h) at 20 °C [15]. | MBA (for molecular biology applications) world wide |
| Zeesan Saliva RNA Sample Collection Kit (401115) – (Zeesan, P.R. China) | Zeesan | Collected sample should be stored and transported under 37 °C. It is recommended to extract RNA within 1 month or be stored below 8 °C for long-term storage (Package insert, see Supplementary information) | EU: CE IVD Outside EU: CFDA approval for clinical use in China |
| DNA/RNA Shield™ Saliva/sputum collection kit (R1210) – (Zymo Research Corp., U.S.A) | Zymo | Each collection tube is pre-filled with 2 mL of DNA/RNA Shield™ that preserves nucleic acids in samples at ambient temperature (DNA > 1 year; RNA at least 1 month). Samples in DNA/RNA Shield™ can be frozen (− 20/− 80 °C) for prolonged periods [16]. | EU: CE IVD Outside EU: FDA 510(k) Number K202641 (substantial equivalence determination decision summary) |
| GeneFiX RNA Saliva collection (RFX-01) – (Isohelix DNA/RNA Sampling and Purification, UK) | Isohelix | RNA is stabilized at room temperature for at least 4 weeks [17]. | For research use only (Patient instructions, Version September 2018) |
| Saliva RNA Collection and Preservation Device Dx (53810) – (Norgen Biotek Corp. Canada) | Norgen | Once collected, saliva RNA is stable for up to 2 months when kept tightly sealed and stored at room temperature [18]. | EU: CE IVD Outside EU: authorized for diagnostic use in Canada by Health Canada |
| Spectrum SDNA-2000 Saliva Collection device – (Spectrum Solutions, USA) | Spectrum | No required post-collection temperature-controlled storage or transport of saliva samples. Provides over 10 days of post-collection stability with no degradation in sample efficacy [19]. | EU: CE Approved and authorized for COVID-19 testing Outside EU: Health Canada Approved and authorized for COVID-19 testing. FDA accelerated emergency use authorization for SARS-CoV-2 testing. |
| OMNIgene ORAL (OME-505) – (DNA Genotek Inc, Canada) | DNAGenotek | Saliva samples collected in OMNIgene ORAL (OM-505) can be stored at room temperature for up to 21 days. Storing at 4 °C is NOT recommended for saliva samples collected in OMNIgene ORAL [20]. |
EU: CE IVD |