TABLE 2.
Modality | Strength(s) | Weakness(es) | Sensitivity (%) | Specificity (%) | Reference(s) |
---|---|---|---|---|---|
Serology | |||||
ELISA | |||||
IgM capture | Decreased rates of false positivity from nonspecific antibody binding Decreased rates of false negativity from competition with preexisting IgG |
Cross-reactivity with other members of the same family Persistence of IgM for >1 yr in some cases |
CDC, 84 | 94 | 39, 62 |
Commercial assays, 98–100a | 92–97 | 24 | |||
Indirect IgG | Fourfold rise in titer identifies recent infection in the presence of preexisting IgM | Cross-reactivity with other members of the same family Long-lasting IgG from prior infections |
CDC, 84 | 39 | |
LDT,c 40 | 94 | 58 | |||
Commercial, 100a | 83 | 42 | |||
IgG avidity assay | Allows for differentiation of recent from past infection | No commercially available tests | |||
PRNT | Quantifies neutralizing antibodies | Requires highly trained staff | |||
Highly specific | Requires biosafety level 3 conditions | ||||
Unaffected by history of prior infections | Slow turnaround time | ||||
IFA | As sensitive as MAC ELISA | Subjective interpretation | IgM, 96–100b | 66–100 | 50, 66 |
IgG, 92–100b | 42–90 | 42, 57 | |||
MIA | Can be highly multiplexed | Not commercially available | 98 | 96 | 42, 57 |
IHC | Useful for confirmatory diagnosis when tissue is available | Limited data on sensitivity and specificity | |||
Molecular diagnostics | |||||
qRT-PCR | High analytic sensitivity and specificity Rapid turnaround time High throughput |
Limited by short time period of viral replication | Serum, 14 | 100 | 70 |
Whole blood, 87b | 100 | 71 | |||
CSF, 57 | 100 | 70 | |||
Urine, 44 | 100 | 72 | |||
mNGS | No prior hypothesis on the target pathogen necessary | Low throughput | |||
Limited by short time period of viral replication |
Relative to the CDC ELISA.
Relative to commercial or laboratory-developed ELISA.
LDT, laboratory-developed test.