Diagnostic Accuracy of FebriDx: A Rapid Test to Detect Immune Responses to Viral and Bacterial Upper Respiratory Infections
Abstract
:1. Introduction
2. Experimental Section
2.1. Design and URI Study Population
2.2. FebriDx Measurements
2.3. Outcome
2.4. Reference Testing Algorithm
2.5. Physician Panel Over-Read
2.6. Statistical Analysis
2.7. Asymptomatic Control Population
3. Results
3.1. URI Study Population
3.1.1. Reference Standard Results
3.1.2. Diagnostic Accuracy of FebriDx
3.1.3. Asymptomatic Control Results
4. Discussion
5. Conclusions
Supplementary Materials
Acknowledgments
Author Contributions
Conflicts of Interest
References
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Characteristic | URI Population (n = 205) | Asymptomatic Control Population (n = 163) |
---|---|---|
Female Gender, n (%) | 123 (60.0) | 90 (55.2) |
Median age, years (IQR) | 29 (15, 46) | 44 (29, 55) |
Age Groups, n (%) | ||
<18 years | 56 (27.3) | 5 (3.1) |
18–50 years | 112 (54.6) | 99 (60.7) |
>50 years | 37 (18.1) | 59 (36.2) |
Race, n (%) | ||
White | 142 (69.3) | 134 (82.2) |
Black | 46 (22.4) | 14 (8.6) |
Other | 17 (8.3) | 15 (9.2) |
Hispanic Ethnicity, n (%) | 88 (42.9) | 64 (39.3) |
Median body temperature, °F (IQR) | 101.5 (101.0, 102.1) | n/a |
Median white blood cell count, thousand cells/mcL (IQR) | 7.8 (5.9, 10.3) | n/a |
Median serum procalcitonin, ng/mL (IQR) | <0.05 (<0.05, 0.07) | n/a |
Median CRP, mg/L (IQR) | 12.1 (3.8, 45.2) | 2.0 (1.0, 4.0) |
Median MxA, ng/mL (IQR) | 4.9 (0.65, 20.2) | <1.0 (0.03, 2.0) |
Reference Standard Classification Criterion | n | Organisms Detected |
---|---|---|
Bacterial | 25 | |
Throat culture positive for bacteria commonly causing pharyngitis and PCT ≥ 0.10 ng/mL | 9 | 6 Group A Streptococcus 3 Group C Streptococcus |
Throat culture positive for other bacteria and PCT ≥ 0.15 ng/mL | 2 | 1 Haemophilus parainfluenza 1 Enterobacter cloacae |
NP/OP PCR positive for atypical bacteria and PCT ≥ 0.10 ng/mL | 1 | 1 Chlamydophila pneumoniae |
Throat culture negative or contaminant, PCR negative, and PCT PCT ≥ 0.25 ng/mL | 5 | 5 none |
Throat culture negative or contaminant, PCR negative, and PCT between 0.15 ng/mL and 0.25 ng/mL, and WBC > 15 k or bands present | 6 | 6 none |
Physician panel over-read classified as bacterial after algorithm suggested negative | 2 | 1 Group A Streptococcus 1 none |
Viral | 53 | |
NP/OP positive PCR for pathogenic virus | 47 | 33 influenza 9 parainfluenza 3 RSV 1 hMPV 1 hMPV and parainfluenza |
NP/OP positive PCR and IgM positive for EBV | 3 | 3 EBV |
Throat culture negative or contaminant, PCR negative or contaminant , and PCT between 0.15 ng/mL and 0.25 ng/mL, and WBC < 15 k, and no bands present | 3 | 1 none 1 Enterobacter gergoviae 1 Group B Streptococcus |
Negative | 127 | |
Throat culture negative or contaminant, P/OP PCR negative, and PCT < 0.15 ng/mL | 79 | 79 none |
Throat culture positive for bacteria commonly causing pharyngitis and PCT < 0.10 ng/mL | 11 | 10 Group A Streptococcus 1 Group C Streptococcus |
Throat culture positive for other bacteria and PCT < 0.15 ng/mL | 37 | 18 S. aureus 3 Group B Streptococcus 3 Klebsiella pneumoniae 3 Group B Strep and S. aureus 3 Enterobacter sp. 2 Streptococcus pneumoniae 2 Proteus mirabilis 1 Citrobacter freundi 1 M. catarrhalis and S. aureus 1 Anicetobacter sp and S. aureus |
FebriDx Test | Reference Standard | Total | |||
---|---|---|---|---|---|
Test | FebriDx Result | Bacterial | Viral | Negative | |
FebriDx | Bacterial | 20 | 1 | 11 | 32 |
Viral | 1 | 46 | 25 | 72 | |
Negative | 4 | 6 | 91 | 101 | |
Total | 25 | 53 | 127 | 205 |
Population | Total n | Bacterial/Viral by Reference Standard, n (%) | FebriDx Test Characteristics | ||||
---|---|---|---|---|---|---|---|
Sens (%) (95% CI) | Spec (%) (95% CI) | PPV (%) (95% CI) | NPV (%) (95% CI) | ||||
(A) Bacterial | |||||||
Full URI population | 205 | 25 (12%) | 80% (59–93%) | 93% (90–97%) | 63% (45–79%) | 97% (94–99%) | |
Age < 18 | 56 | 5 (8.9%) | 60% (16–95%) | 100% (94–100%) * | 100% (30–100%) * | 96% (88–100%) | |
Age 18–50 | 112 | 13 (12%) | 85% (56–98%) | 90% (84–96%) | 55% (33–77%) | 98% (93–100%) | |
Age > 50 | 37 | 7 (19%) | 86% (43–100%) | 90% (75–98%) | 67% (31–93%) | 96% (83–100%) | |
(B) Viral | |||||||
Full URI population | 205 | 53 (26%) | 87% (75–95%) | 83% (77–89%) | 64% (53–75%) | 95% (90–98%) | |
Age <18 | 56 | 25 (45%) | 96% (80–100%) | 55% (37–73%) | 63% (47–78%) | 94% (73–100%) | |
Age 18–50 | 112 | 21 (19%) | 76% (53–92%) | 87% (80–93%) | 57% (38–76%) | 94% (87–98%) | |
Age >50 | 37 | 7 (19%) | 86% (42–100%) | 100% (89–100%)* | 100% (54–100%) * | 97% (83–100%) |
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Self, W.H.; Rosen, J.; Sharp, S.C.; Filbin, M.R.; Hou, P.C.; Parekh, A.D.; Kurz, M.C.; Shapiro, N.I. Diagnostic Accuracy of FebriDx: A Rapid Test to Detect Immune Responses to Viral and Bacterial Upper Respiratory Infections. J. Clin. Med. 2017, 6, 94. https://doi.org/10.3390/jcm6100094
Self WH, Rosen J, Sharp SC, Filbin MR, Hou PC, Parekh AD, Kurz MC, Shapiro NI. Diagnostic Accuracy of FebriDx: A Rapid Test to Detect Immune Responses to Viral and Bacterial Upper Respiratory Infections. Journal of Clinical Medicine. 2017; 6(10):94. https://doi.org/10.3390/jcm6100094
Chicago/Turabian StyleSelf, Wesley H., Jeffrey Rosen, Stephan C. Sharp, Michael R. Filbin, Peter C. Hou, Amisha D. Parekh, Michael C. Kurz, and Nathan. I. Shapiro. 2017. "Diagnostic Accuracy of FebriDx: A Rapid Test to Detect Immune Responses to Viral and Bacterial Upper Respiratory Infections" Journal of Clinical Medicine 6, no. 10: 94. https://doi.org/10.3390/jcm6100094
APA StyleSelf, W. H., Rosen, J., Sharp, S. C., Filbin, M. R., Hou, P. C., Parekh, A. D., Kurz, M. C., & Shapiro, N. I. (2017). Diagnostic Accuracy of FebriDx: A Rapid Test to Detect Immune Responses to Viral and Bacterial Upper Respiratory Infections. Journal of Clinical Medicine, 6(10), 94. https://doi.org/10.3390/jcm6100094