Table 1.
ASSURED-SQVM principles as applied to current diagnostics for SARS-CoV-2 and other infectious diseases
Criteria | Detection methods | ||||
Direct detection of virus | Detection of antibodies |
Detection of inflammatory biomarkers |
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|
Culture |
Nucleic Acid |
Antigen capture |
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Affordable | No, requires laboratory setting, trained personnel | No. Instrument, consumables are expensive | Yes | Yes | Requires a clinical laboratory to perform the tests for multiple biomarkers |
Sensitive | Very high | High | Depends on the QC of the antibodies and manufacturer | Depends on the QC of the antibodies and manufacturer | Depends on the QC of the antibodies and manufacturer |
Selective | Very high | Very high, but requires the right primers | Depends on the QC of the antibodies and manufacturer | Depends on the QC of the antibodies and manufacturer | Depends on the QC of the antibodies and manufacturer |
Rapid | No, requires days. | Tabletop instruments provide results in ≤ 15 min | Lateral flow tests will provide results in ≤ 15 min. | Lateral flow tests will provide results in ≤ 15 min. | Blood tests take 24–28 hours |
Robust | No, reagents require refrigeration. | Yes/No, some reagents may require refrigeration | No, depends on antibody stability. May require refrigeration | No, depends on antibody stability. May require refrigeration | No, reagents require refrigeration |
User-friendly | No, requires trained personnel | Only the new integrated systems are user friendly. | Yes | Yes | No, requires trained personnel |
Equipment free | No | No | Yes | Yes | No |
Deliverable to end users | No, requires laboratory | No, requires space, electricity | Yes, small footprint, portable | Yes, small footprint, portable | No, requires laboratory |
Self-testing | No | No | Yes | Yes | No |
Quantitative | Yes, but takes days | Tabletop systems provide yes/no answer; | No | No | Yes, but takes hours/days |
Viability | Yes | No | No | N/A | N/A |
Multiplexing | Yes, but requires equipment | Capability exists, but is expensive | Yes, but becomes more expensive | Yes, but becomes more expensive | Yes, but requires equipment |