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Study
(Sample Size)
(Exhibited or Reported)
Shapiro
Exhibited on Enrollment
(n = 121/220)
16
Shapiro
(n = 220)
16
Self
(n = 205)
17
PPA, Positive Percent Agreement; NPA, Negative Percent Agreement; PPV, Positive Predictive Value; NPV, Negative Predictive Value; CI, Confidence Interval
PROSPECTIVE CLINICAL STUDIES FEBRIDX
Viral infection in patients with suspected COVID-19
Two real-world diagnostic accuracy studies evaluating FebriDx
COVID-19 were performed during the first wave (March-April 2020) of the COVID-19 pandemic.
diagnostic accuracy were calculated based on FebriDx
(i) SARS-CoV-2 PCR on combined nose and throat swabs
Centre for Disease Prevention and Control (ECDC) and U.S. Centers for Disease Control and Prevention (CDC) probable
case definition for COVID-19 (any person meeting the clinical criteria with an epidemiological link or any person meeting
the diagnostic criteria [radiological evidence consistent with COVID-19]).
•
248 symptomatic subjects with suspected COVID-19 were enrolled in the ED and in-patient setting
o 48% (118/248) of the cohort had SARS-CoV-2 confirmed by PCR (ECDC/CDC definition for confirmed COVID-19)
o 50% (125/248) of the cohort had met the ECDC/CDC case definition for probable (n = 7) or
confirmed (n = 118) COVID-19
•
47 symptomatic subjects with suspected COVID-19 were enrolled in the ED and in-patient setting
o 66% (31/47) had SARS-CoV-2 confirmed by PCR
o 74% (35/47) had a diagnosis of COVID-19 (n = 31 confirmed by PCR; n = 3 met ECDC/CDC case definition
for probable COVID-19 together with antibodies)
RESULTS
FebriDx
v. SARS-CoV-2 PCR
®
FebriDx
v. Probable Case
®
Definition (ECDC/CDC)
SARS-CoV-2 PCR, Positive
Antibody Test, or Probable Case
Definition (ECDC/CDC)
FebriDx
v. Bacterial Infection
®
Fever
(55%)
Reported
within 3 days
Reported
within 3 days
DIAGNOSTIC PERFORMANCE:
®
n
248
11
248
11
47
11
47
16
PPA
Diagnosis
[95% CI]
90%
Viral
[81-96]
90%
Viral
[83-94]
87%
Viral
[75-95]
in hospitalized subjects with suspected
®
results compared to the reference standard of either
®
and/or SARS-CoV-2 serum antibody test
3
20,21
Sensitivity
Specificity
[95% CI]
[95% CI]
93%
86%
110/118
112/130
[87-97]
[79-92]
93.6%
91.1%
117/125
112/123
[87.8-97.2]
[84.5-95.5]
100%
100%
34/34
13/13
[87.4-100]
[71.7-100]
100%
92.3%
8/8
36/39
[59.8-100]
[78-98]
9
NPA
PPV
[95% CI]
[95% CI]
78%
89%
[62-89]
[82-93]
76%
83%
[66-84]
[77-87]
83%
64%
[77-89]
[53-75]
3,4
as well as the European
4
3
4
PPV
[95% CI]
86%
110/128
[79-91]
91.4%
112/120
[84.5-95.5]
100%
34/34
[84.7-100]
72.7%
8/11
[39.3-92.3]
NPV
[95% CI]
80%
[67-89]
85%
[77-90]
95%
[90-98]
Measures of
NPV
[95% CI]
93%
112/120
[87-97]
93.3%
117/128
[88.7-96.8]
100%
13/13
[71.7-100]
100%
36/36
[88-100]
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