Diagnostic kit for IgM Antibody to Enterovirus 71 Colloidal Gold

Diagnostic kit for IgM Antibody to Enterovirus 71 Colloidal Gold   

Products Details

Diagnostic kit for IgM Antibody to Enterovirus 71

Colloidal Gold

Production information
Model Number EV-71 Packing 25 Tests/ kit, 30kits/CTN
Name Diagnostic kit for IgM Antibody to Enterovirus 71 Colloidal Gold Instrument  classification Class I
Features High sensitivity, Easy opeation Certificate CE/ ISO13485
Accuracy > 99% Shelf life Two Years
Methodology Colloidal Gold OEM/ODM service Avaliable
Human enterovirus 71 (EV71) belongs to the family Picornaviridae. The genome is a single-stranded positive stranded RNA with a length of about 7400 nucleotides and only one open reading frame. The encoded polyprotein contains about 2190 amino acids. This polyprotein can be further hydrolyzed to P1, P2 and P3 precursor proteins. P1 precursor protein codes structural proteins VP1, VP2, VP3 and VP4; P2 and P3 code 7 nonstructural proteins (2A~2C and 3A~3D). In these 4 structural proteins, except VP4 that is embedded in inner side of viral capsid and closely linked with core, other 3 structural proteins are all exposed on the surface of virus particles. Thus, antigenic determinants are basically located on VP1~VP3.
Intend Use
This kit is applicable to the in vitro quantitative detection on the content of IgM Antibody to Enterovirus 71 in human whole blood, serum or plasma and is mainly used for implementing auxiliary diagnosis of acute EV71 infection. This kit only provides the test result of IgM Antibody to Enterovirus 71 and the obtained result shall be analyzed in combination with other clinical information. It must only be used by healthcare professionals.
The WIZ BIOTECH reagent test will be compared with the control reagent:
Test result of wiz  Test result of reference reagents     Positive coincidence rate:99.39%(95%C.I.96.61%~99.89%)     Negative coincidence rate:100%(95%C.I.97.63%~100%) Total  compliance rate: 99.69%(95%C.I.98.26%~99.94%)
Positive Negative Total
Positive 162 0 162
Negative 1 158 159
Total 163 158 321
Test procedure
 1 Take the test device out of aluminum foil bag, place it on a flat tabletop and properlymark the sample.
 2  Add 10uL of serum or plasma sample or 20uL of whole blood to sample hole, and then drip 100uL (about 2-3 drops) of sample diluent to sample hole and start timing.
 3 Result should be read within 10-15 minutes. Test result will be invalid after 15 minutes.
Note: each sample shall be pipetted by clean disposable pipette to avoid cross contamination.  Feature: •  High sensitive •  result reading in 15 minutes •  Easy operation • Factory direct price • Do not need extra machine for result reading  

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