Table 1 Diagnostic performance of proposed biosensor for detection of SARS-CoV-2 by samples and study groups in FVL case.

From: Performance assessment of disposable carbon-based immunosensors for the detection of SARS-CoV-2 infections

  

Proposed Immunosensor

RT-PCR*

NA

OS

SA

At least one positive sample per participantd

All samples

+

−

+

−

+

−

+

−

+

−

Patientsa

+

4

1

13

1

6

3

15

2

23

5

−

0

0

0

0

0

0

0

0

0

0

Co-habitantsb

+

0

2

2

0

2

0

2

0

4

2

−

0

2

3

3

3

2

4

3

6

7

Healthy donorsc

+

0

0

0

0

0

0

0

0

0

0

−

2

2

2

5

2

4

5

4

6

11

All

+

4

3

15

1

8

3

17

2

27

7

−

2

4

5

8

5

6

9

7

12

18

PPV % (95% CI)

66.7 (22.3–95.7)

75 (50.9–91.3)

61.5 (31.6–86.1)

65.4 (44.3–82.8)

69.2 (52.4–83)

NPV % (95% CI)

57.1 (18.4–90.1)

88.9 (51.8–99.7)

66.7 (29.9–92.5)

77.8 (39.9–97.2)

72 (50.6–87.9)

Likelihood ratio (+)

1.71 (0.47–6.30)

2.44 (1.21–4.90)

1.60 (0.76–3.36)

1.59 (1.01–2.52)

1.99 (1.24–3.18)

Likelihood ratio (−)

0.64 (0.23–1.79)

0.10 (0.01–0.71)

0.50 (0.17–1.51)

0.24 (0.06–1.00)

0.34 (0.17–0.71)

  1. ‘+’: Indicates a measured sample that tested positive for SARS-CoV-2 infection.
  2. ‘−’: Indicates a measured sample that tested negative for SARS-CoV-2 infection.
  3. Samples types: nasopharyngeal aspirate (NA), oropharyngeal swab (OS), and saliva (SA).
  4. *The sample type used for RT-PCR as the standard diagnosis was NA.
  5. aPatients: Participants with symptomatic SARS-CoV-2 infection.
  6. bCo-habitants: Participants asymptomatic co-habitants of patients.
  7. cHealthy donors: Participants with no history nor symptoms of COVID-19 infection.
  8. dCalculated based on RT-PCR data from NA and sensor results considering positivity in at least one positive sample from each participant. Not validated against subsequent serological (antibody) testing.
  9. eCalculated based on RT-PCR data from NA and sensor results considering each independent sample.
  10. Prevalence = Disease present/Disease absent.
  11. Sensitivity = True positive / (True positive + False negative).
  12. Specificity = True negative / (True negative + False positive).
  13. PPV = (sensitivity × prevalence) / [(sensitivity x prevalence) + ((1–specificity) × (1 − prevalence))].
  14. NPV = (specificity × (1–prevalence)) / [(specificity × (1–prevalence)) + ((1 − sensitivity) x prevalence)].
  15. Likelihood ratio (+) = True positive rate / False positive rate = Sensitivity / (1 − Specificity).
  16. Likelihood ratio (−) = False negative rate / True negative rate = (1 − Sensitivity) / Specificity.
  17. In bold. p ≤ 0.05 (Fischer’s exact test).
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