Zika IgM ELISA Test CE

Zika IgM ELISA Test CE

The RecombiLISA Zika IgM ELISA Test is a solid-phase enzyme-linked immunosorbent assay based on the principle of the indirect immunoassay technique.  The two main kit components are:

  • A 96-well breakable microplate pre-coated with Zika NS1 antigen
  • A liquid conjugate solution composed of horseradish peroxidase (HRP-anti-human IgM conjugates)

This test is intended for the qualitative detection of IgM anti-Zika virus in human serum or plasma. It is intended to be used by professionals as an aid in the diagnosis of an acute infection with Zika virus.  Any interpretation or use of this test result must also rely on other clinical findings as well as on the professional judgment of health care providers.

Recommended for use:

  • Symptomatic individuals, or Pregnant women with or without symptoms, when

1. living in/having recently traveled to an area with Zika

2. having sex with a partner who lives in or having traveled to an area with Zika

IgM antibodies are typically detectable 3-5 days after infection and may persist for 2-12 weeks. Serological detection of IgM antibodies compliments virus RNA detection by Real-Time PCR, extending the detection window beyond the viraemic phase. However cross-reactivity with closely related viruses including dengue, yellow fever, Japanese encephalitis, and West Nile are often observed.

  • Sensitivity: 94.7%
  • Specificity: 98.5%
  • Cross Reactivity: No false positive results were observed on specimens of HCV, Syphilis, HBsAg, HIV, H. pylori, Malaria, No noticeable cross-reaction with non-flavivirus disease specimens, including CHIK IgM, pregnancy, HBsAg, HCV, TBE, HIV, H. pylori, syphilis, parovirus, malaria, varicella zoster, Yellow Fever and Zika IgG. Cross-reaction with CMV was 4.3% (1/23), as well as West Nile 16.7% (2/12) and dengue IgM 27.3% (6/22), respectively.
  • Interference: No interference was seen with bilirubin (6.7-20 mg/dL); hemoglobin (0.67-2 g/L); human IgG (3.3-10 mg/mL); human serum albumin (60-80 g/L); ANA (1:3 - 1:1); HAMA (1:3 - 1:1) RF (up to 2900 IU/mL)
  • Intra Assay Precision: CV < 6% 
  • Inter Assay Precision: CV <  5%
  • Shelf life: 18 months
  • Open vial stability:  8 weeks  at 2-8°C, or until the expiration date
  • Zika NS1 Ag Coated Microwell
  • HRP-anti-human IgM Conjugates
  • Zika IgM Positive Control
  • Zika IgM Negative Control
  • Sample Treatment Buffer
  • Assay Buffer
  • Wash Buffer (30 X Concentrate)
  • TMB Substrate
  • Stop Solution
  • ELISA Working Sheet
  • Product Insert

Catalog #

Product

Quantity

Specimen

E0320

Zika IgM ELISA Test 

96/kit

S, P

To learn about distribution opportunities or for additional product information, please contact <http://www.privatedaddy.com?q=UnlnenhVdUBMPAFndkJYZiJGTXZmVnk-3D_19>

Product Features
  • Sensitivity: 94.7%
  • Specificity: 98.5%
  • Cross Reactivity: No false positive results were observed on specimens of HCV, Syphilis, HBsAg, HIV, H. pylori, Malaria, No noticeable cross-reaction with non-flavivirus disease specimens, including CHIK IgM, pregnancy, HBsAg, HCV, TBE, HIV, H. pylori, syphilis, parovirus, malaria, varicella zoster, Yellow Fever and Zika IgG. Cross-reaction with CMV was 4.3% (1/23), as well as West Nile 16.7% (2/12) and dengue IgM 27.3% (6/22), respectively.
  • Interference: No interference was seen with bilirubin (6.7-20 mg/dL); hemoglobin (0.67-2 g/L); human IgG (3.3-10 mg/mL); human serum albumin (60-80 g/L); ANA (1:3 - 1:1); HAMA (1:3 - 1:1) RF (up to 2900 IU/mL)
  • Intra Assay Precision: CV < 6% 
  • Inter Assay Precision: CV <  5%
  • Shelf life: 18 months
  • Open vial stability:  8 weeks  at 2-8°C, or until the expiration date
Kit Components
  • Zika NS1 Ag Coated Microwell
  • HRP-anti-human IgM Conjugates
  • Zika IgM Positive Control
  • Zika IgM Negative Control
  • Sample Treatment Buffer
  • Assay Buffer
  • Wash Buffer (30 X Concentrate)
  • TMB Substrate
  • Stop Solution
  • ELISA Working Sheet
  • Product Insert
Support
Order Information

Catalog #

Product

Quantity

Specimen

E0320

Zika IgM ELISA Test 

96/kit

S, P

To learn about distribution opportunities or for additional product information, please contact <http://www.privatedaddy.com?q=UnlnenhVdUBMPAFndkJYZiJGTXZmVnk-3D_19>


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