Table 2.
Comparison of sensitivity (Sen), specificity (Spe), and diagnostic odds ratio (DOR, with 95%CI) of FDA-approved respiratory panels, based on data reported by manufacturers to the FDA as part of the approval processes for the assays. For the purposes of surveillance studies, assays with larger DORs have better accuracy for the pathogen(s) of interest.
| FilmArray RP |
Nanosphere RP Flex |
eSensor RVP |
Luminex NxTAG RPP |
|||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sen | Spe | DOR | 95% CI | Sen | Spe | DOR | 95% CI | Sen | Spe | DOR | 95% CI | Sen | Spe | DOR | 95% CI | |
| Adeno | 95% | 97% | 547.59 | 192–1561.3* | 86% | 97% | 213.2 | 2.8–469.9* | n.d. | n.d. | n.d. | n.d. | 100% | 98% | 61,438.5 | 52,533.3–71,853.3* |
| Adeno B/E | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 100% | 99% | 110,001 | 46,915.4–257,915.7* | n.d. | n.d. | n.d. | n.d. |
| Adeno C | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 100% | 97% | 28,383.35294 | 11,911.8–67,631.5* | n.d. | n.d. | n.d. | n.d. |
| CoHKU1 | 100% | 99% | 123,876 | 49,003–313,149.2 | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 93% | 100% | 6529.2 | 533.9–79,836.2* |
| CoNL63 | 100% | 99% | 165,501 | 82,619–331,528.6 | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 95% | 99% | 3435.8 | 1469.6–8032.4* |
| Co229E | 92% | 100% | 3671.68 | 395.8–34,059.4* | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 100% | 99% | 165,501 | 129,533.6–211,455.4* |
| CoOC43 | 81% | 100% | 1371.94 | 426.1–4417.5* | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 97% | 100% | 7532.3 | 798.6–71,039.91* |
| hMPV | 97% | 100% | 7171.37 | 1496.1–34,374.1* | 100% | 100% | 332,001 | 5.7–778,167.9* | 100% | 100% | 498,501 | 121,426.9–2,046,525* | 94% | 99% | 1665.9 | 1183.1–2345.6* |
| Rhino/Entero | 98% | 94% | 561 | 295.3–1065.6* | 82% | 97% | 151.5 | 3.7–219.2* | 89% | 96% | 203.5166192 | 46.3–895.1* | 95% | 96% | 527.7 | 442.2–629.8* |
| InfA | 100% | 100% | 998,001 | 295.3–1065.6* | 98% | 99% | 9579.4 | 1.4–74,460.2* | 96% | 95% | 488.1794872 | 190.7–1249.8* | 95% | 98% | 911.8 | 745.3–1115.5 |
| InfA/H1 | 100% | 100% | 998,001 | 319,033.3–3,121,950* | 98% | 100% | 14,773.7 | 1.3–125,258.6* | 97% | 100% | 29,273.72727 | 3983.8–215,106.9* | 100% | 99% | 110,001 | 90,760.01–133,321.1* |
| InfA/H3 | 100% | 100% | 998,001 | 374,104–2,662,377* | 100% | 100% | 498,501 | 4.6–1,530,067* | 100% | 97% | 37,424.07692 | 23,683.6–59,161.3* | 99% | 98% | 2789.4 | 1374.7–5659.9* |
| InfA/H1-2009 | 100% | 100% | 998,001 | 790,354.4–1,260,202* | n.d. | n.d. | n.d. | n.d. | 100% | 99% | 65,601 | 36,662.8–117,380.4* | n.d. | n.d. | n.d. | n.d. |
| InfB | 100% | 100% | 998,001 | 22,630.6–4,394,843* | 98% | 100% | 12,201 | 1.4–9445.6* | 93% | 98% | 665.4736842 | 239.3–1850.4* | 96% | 99% | 3082.2 | 1603.4–5924.7* |
| Para1 | 100% | 100% | 998,001 | 126,362.2–7,882,150* | 100% | 100% | 8991 | 1.8–55,995.1* | 100% | 100% | 998,001 | 111,447.8–8,936,976* | 100% | 100% | 998,001 | 94,900.4–10,495,281* |
| Para2 | 98% | 100% | 9277.19 | 1136.6–75,719* | 100% | 100% | 11,975.0 | 1.1–123,475.6* | 83% | 100% | 2436.294118 | 189.0–31,397.8* | 50% | 100% | 999 | 2.78–357,781.9* |
| Para3 | 96% | 99% | 3599.48 | 765.4–16,927.5* | 82% | 100% | 4677.1 | 1.9–25,206.3* | 94% | 98% | 677.4922623 | 226.6–2025.2* | 95% | 99% | 2459.3 | 279.6–21,630.8* |
| Para4 | 100% | 100% | 248,751 | 92,525.8–668,754.6* | 79% | 100% | 1900.0 | 2.2–7629.9* | n.d. | n.d. | n.d. | n.d. | 60% | 100% | 298.5 | 48.7–1828.4* |
| RSV | 99% | 98% | 9579.43 | 1287.9–71,249.8* | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. |
| RSVA | n.d. | n.d. | n.d. | n.d. | 100% | 100% | 998,001 | 4.4–3,408,002* | 100% | 95% | 17,850.0566 | 12,343.6–25,812.9* | 100% | 99% | 141,715.3 | 120,945.7–166,051.6* |
| RSVB | n.d. | n.d. | n.d. | n.d. | 100% | 99% | 82,251 | 4.6–221,854.5* | 100% | 96% | 23,366.85366 | 14,391.4–37,939.9* | 99% | 99% | 10,878.8 | 5528–7-21,405.9* |
| Bocavirus | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 96% | 99% | 2407.6 | 289.3–20,032.8* |
| B.pert | 67% | 100% | 2001 | 90.2–44,392.2* | 100% | 100% | 998,001 | 3.3–4,702,441* | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. |
| B. para/bronch | n.d. | n.d. | n.d. | 720.4–49,759.4* | 100% | 100% | 998,001 | 1.5–11,010,489* | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. |
| B. holmesii | n.d. | n.d. | n.d. | n.d. | 100% | 100% | 998,001 | 2.2–7,088,148* | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. |
| C.pneumo | 100% | 100% | 998,001 | 116,527.2–8,547,411 | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | – | 100% | 0 | n.a. |
| M.pneumo | 96% | 100% | 7580.37 | 851.6–67,473.8* | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 78% | 100% | 3501 | 372.4–32,916.5* |
DOR: Diagnostic Odds Ratio calculated as LR+/LR– per Glas et al. FilmArray RP: InfluA/H1 Sen not reported. Luminex xTAP RPP: C.pneumo site testing results for discrepant specimens were available or reported.
n.d.: target is not included as a target in the panel.
As reported in the FDA-decision summary, Sen was reported as 0%; thus, DOR was not able to be calculated.
95% CI: Calculated as LN(DOR) ± 1.96 (√(1/TP + 1/TN + 1/FP + 1/FN)),*p ≤ 0.05.
When reported, instead of using Sen and Spe at 100%, we used 99.9% in our calculations to prevent either a DOR = undefined,