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EV-71

The human Enterovirus 71 (EV71), the newest member of Enteroviridae, is noteworthy for its etiological role in epidemics of severe neurological diseases in children. It appears to be emerging as an important virulent neurotropic enterovirus in the upcoming era of poliomyelitis eradication. The illness usually peaks in June or July. EV71 infection may either be asymptomatic or may cause diarrhea and rashes. EV71 as one of the major causative agents for hand, foot and mouth disease (HFMD), is sometimes associated with severe central nervous system diseases. Direct detection of the virus is the mainstay of diagnosis. EV71 can be isolated from throat and stool specimens, as well as from skin vesicle fluid. PCR testing provides generally greater sensitivity than cultures for throat and stool specimens, and viral RNA has also been detected in vesicular fluid, blood and urine. EV71-specific serological assays, including tests specific for IgM antibody, have also been developed to assist for early and easier diagnosis of the disease.

Pathogens identified in local institutional HFMD outbreaks

Seasonality of by onset date

Wantai EV71-IgM ELISA is a solid-phase antibody capture assay in which microwell strips are pre-coated with antibodies directed to anti-human IgM antibodies. The patient’s sample is added, and any IgM antibodies will be captured in the wells. Purified EV71 antigen, and monoclonal anti-EV71 antibodies conjugated to the enzyme horseradish peroxidase are simultaneously added into the wells. They will specifically react only with the EV71-IgM antibodies captured in the wells. Chromogen solutions are then added into the wells. In presence of EV71-IgM antibody in the sample, the colourless chromogens are hydrolyzed by the bound HRP-conjugate to a blue-coloured product. The colour intensity can be measured and is proportional to the amount of antibody captured in the wells, and thus to the amount of antibody in the sample.

Wantai EV71-IgM Rapid Test is a single use, rapid device intended for the qualitative detection of IgM-class antibodies to human enterovirus-71 (EV71) in serum, plasma or whole blood samples. It is intended to be used in clinical laboratories for early diagnosis and management of patients related to infection with EV71.

Wantai EV71-IgM Rapid Test - performance characteristics study

Samples
Wantai EV71 IgM Rapid Test Positive
Wantai EV71 IgM Rapid Test Negative
Sensitivity
Specificity
EV71 PCR positive samples
23
3
88.5%
(23/26)
--
Non-EV71 hand, foot and mouth diseases samples
9
177
--
95.2%
(177/186)

In total, 212 clinical serum samples were tested, including 26 EV71 PCR positive samples and 186 non-EV71 HFMD samples. The test demonstrated a sensitivity of 88.5% (23/26) and a specificity of 95.2% (177/186).

Wantai EV71-IgM Rapid Test demonstrated very high sensitivity and specificity during this evaluation. The test is applicable for clinical laboratories for early diagnosis and management of patients related to infection with EV71.

Download clinical evaluation report 1

 



  Catalog No.
  Product
Certification
IFU
  WR-1696
  EV-71 IgM ELISA

  WJ-2010
  EV-71 IgM Rapid Test
 

Download product brochure 1

Wantai EV-71 IgM ELISA : performance characteristics

Study I - Analysis performance

Samples
Wantai EV-71 IgM ELISA positive
Wantai EV-71 IgM ELISA negative
Sensitivity
Specificity
Confirmed EV71 positive samples
178
11
94.2%(178/189)
--
Healthy individuals' samples
24
3682
--
99.4%(3682/3706)

Study II - Analysis performance

Samples
Wantai EV-71 IgM ELISA positive
Wantai EV-71 IgM ELISA negative
Sensitivity
Specificity
Confirmed EV71 positive samples
25
2
92.6%(25/27)
--
Non-EV71 hand, foot and mouth diseases samples
1
17
--
94.4%(17/18)

Study III - The correlation between the days from the onset of symptoms and detectable rate using Wantai EV-71 IgM ELISA

Days from onset
Positive number detected
Total sample number
Positive rate
1 day
23
26
88.5%
2 days
40
53
75.5%
3 days
35
42
83.3%
4 days
18
21
85.7%
5-6 days
50
50
100.0%
7-10 days
51
54
94.4%
11-30 days
52
57
91.2%
31-41 days
24
25
96.0%
Total
293
328
89.3%

The results indicate that Wantai EV71-IgM ELISA had a high detectable rate at the early period of infection with EV71. The average detectable rate was up to 86.5% within the first 1-6 days after onset of symptoms.

Study IV - The correlation between the days from the onset of symptoms and IgM antibody levels detected in the patients' serum using Wantai EV71-IgM ELISA

     

The detectable level of IgM antibodies increase gradually from the first day of onset, reach a maximum after 13-14 days, and then decline gradually. IgM antibodies can be detected even until the 40th day after onset.

Study V - The cross reaction with CA16 using Wantai EV-71 IgM ELISA

    

Few cross reaction with CA16 for Wantai EV71-IgM ELISA. 28 samples infected with CA16 were detected positive, but there were only 3 samples of which the A values were over 0.3. However, there were only 12 samples of which A values were below 0.3 among 206 EV71 infected samples which were detected positive.

 


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