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Guideline for the Prevention and Control of Norovirus Gastroenteritis Outbreaks in Healthcare Settings, 2011

Q2: What are the best methods to identify a norovirus outbreak in a healthcare setting?

Diagnostic methods – Fecal specimens

EM

Author, Yr (Ref) Study Design Quality Study Objective Population and Setting N Results Comments Ref ID_Data extracted by
Rabenau, H; 2003 17 Diagnostic study
 
1, 2
To compare the sensitivity and specificity of:
1. ELISA when compared with a) TEM and PCR or b) PCR only
2. TEM when compared with a) ELISA and PCR or b) PCR only
Inhabitants and employees of homes for the elderly (in Frankfurt, Germany) aged 20 to >60 years; 73% females, 42% > 60 yrs.
 
244 stool samples from 227 patients
Test characteristics (%) for ELISA
When compared with TEM and PCR
Sensitivity – 50.0
Specificity – 96.2
PPV – 68.0
NPV – 92.2
(True Positive[TP] – 17; True Negative[TN] – 202; FP – 8; FN – 17)
When compared with PCR only
Sensitivity – 31.3
Specificity – 94.9
PPV – 60.0
NPV – 84.9
(TP – 15; TN – 186; FP – 10; FN – 33)
 
Test characteristics (%) for TEM
When compared with ELISA and PCR
Sensitivity – 88.2
Specificity – 99.0
PPV – 93.8
NPV – 98.1
(TP – 30; TN – 208; FP – 2; FN – 4)
When compared with PCR only
Sensitivity – 58.3
Specificity – 98.0
PPV – 87.5
NPV – 90.6
(TP – 28; TN – 192; FP – 4; FN – 20)
 
Test characteristics (%) for PCR
When compared with ELISA and TEM
Sensitivity – 94.1
Specificity – 92.4
PPV – 66.7
NPV – 99.0
(TP – 32; TN – 194; FP – 16; FN – 2)
Power and sample size not reported.
 
Prevalence not reported
801_RA
Richards, A; 2003 119 Diagnostic Study
 
1,2
To determine the test characteristics of ELISA and EM in detecting norwalk-like virus (NLV) infection when compared with PCR Fecal samples collected from patients involved in outbreaks of gastroenteritis in the UK
 
531 fecal samples
Test characteristics (%) of ELISA vs. PCR
Sensitivity – 55.5(51.1-60.0)
Specificity – 98.3(97.1-99.9)
PPV – 95.0(CI not reported)
NPV – 76.9 (CI not reported)
 
Test characteristics (%) of EM vs. PCR
Sensitivity – 23.9(19.5-28.1)
Specificity – 99.2(98.3-100)
PPV – 93.9(CI not reported)
NPV – 70.7(CI not reported)
 
Identification of NLV as the cause of an outbreak (% of outbreaks)
When the causative agent was defined by ≥ 2 positive samples
EM – 7.2
ELISA – 18.6
PCR – 41.5
When the causative agent was defined by ≥ 1 positive samples
EM – 19.6
ELISA – 47.8
PCR – 62.8
 
Sensitivity; Specificity of ELISA based on number of samples collected
2 samples – 52.9; 100
≥4 – 69.2; 100
≥6 – 71.4; 100
 
Other results
Agreement between ELISA and PCR – 81.8% (Kappa = 0.57)
Sensitivity of ELISA was significantly increased when compared with EM (P<0.01)
Power and sample size not reported.
 
Prevalence not reported
848_RA

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