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. Author manuscript; available in PMC: 2020 Apr 22.
Published in final edited form as: J Virol Methods. 2018 Jun 30;260:26–33. doi: 10.1016/j.jviromet.2018.06.018

Table 4.

Sensitivity and specificity of kits tested at 3 laboratories compared to confirmed reference results.

Overall CDC Diagnosis Laboratory results
ADB-DRL PHAC MPIR Combined




Test Measure N POS EQ NEG % POS EQ NEG % POS EQ NEG % % (95% CI)
InBiosa Sensitivity 64 54b NA 9 84.4 52b NA 11 81.3 53b NA 11 82.8 82.8 (77.0, 87.7)
Specificityc 78 14b NA 57 73.1 6b NA 71 91.0 10b NA 67 87.2 83.3 (78.0, 87.6)
Specificityd 155 45b NA 110e 71.0 40b NA 115d 74.2 42b NA 113e 72.9 72.7 (68.5,76.6)
NovaTec Sensitivityf 64 40 3 21 67.2 40 5 19 70.3 45 1 18 71.9 69.8 (63.1, 76.0)
Specificityc 78 2 0 76 97.4 1 0 77 98.7 2 0 76 97.4 97.9 (95.5, 99.2)
Specificityd 155 3 0 152 98.1 2 0 153 98.7 6 0 149 96.1 97.6 (96.0, 98.8)
Euroimmun IgM Sensitivitye 64 28 4 32 50.0 30 3 31 51.6 33 4 27 57.8 53.1 (46.1, 60.1)
Specificityc 78 0 1 77 98.7 1 1 76 97.4 3 1 74 96.2 97.0 (94.3, 98.7)
Specificityd 155 2 1 152 98.1 2 1 152 98.1 5 1 149 96.8 97.4 (95.7, 98.6)
Euroimmun IgG Sensitivityf 64 20 1 43 32.8 20 0 44 31.3 22 3 39 39.1 34.4 (27.9, 41.3)
Specificityc 78 1 0 77 98.7 0 1 77 98.7 2 0 76 97.4 98.3 (96.1, 99.5)
Specificityd 155 5 2 148 95.5 5 3 147 94.8 9 3 143 94.2 94.2 (91.8, 96.1)
Euroimmun IgM + IgG Sensitivityf 64 39 NA 25 60.9 39 NA 25 60.9 42 NA 22 65.6 62.5 (55.5, 69.1)
Specificityc 78 1 NA 77 98.7 1 NA 77 98.7 5 NA 73 93.6 97.0 (94.3, 98.7)
Specificityd 155 7 NA 148 95.5 7 NA 148 95.5 14 NA 141 91.0 94.0 (91.6, 95.9)
a

For InBios, positive plus negative numbers do not add up to N in some cases, because of the “Presumptive Other Flavivirus” category.

b

For the InBios kit, positive results are considered both “Presumptive Zika positive” and “Possible Zika positive”.

c

Specificity denominator consists of true negative samples only.

d

Specificity denominator consists of 10 YF, 10 WN, 10 CHIK, 47 DEN and 78 NEG samples.

e

Negative plus Presumptive Other Flavivirus results are classified as a negative result.

f

Sensitivity was calculated where equivocal results were classified as positive.