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Respiratory Syncytial Virus (RSV) IgM ELISA Kit

INTENDED USE

Human RSV IgM ELISA kit is a method intended for analysing in-vitro quantitative levels of human IgM antibodies against respiratory syncytial virus (RSV IgM) using serum and plasma. This assay has a minimum analytical sensitivity limit of 1.7 U/ml.

BACKGROUND

Respiratory-syncytial virus (RSV) is a linear negative sense, single stranded RNA genome which contains a lipoprotein coat, it belongs to the Pneumoviridae family of viruses. RSV is approx. 15,000 nucleotides in length and contains four viral genes that code for intracellular proteins, namely M (matrix protein), N (nucleoprotein), L (“large” protein) and P (phosphoprotein). These proteins play vital roles for cellular processes such as particle budding, transcription and replication. The virus is responsible for causing infection of the lungs or the respiratory tract and it can be transmitted via large droplets or direct contact with infected people. ELISA assay procedures are useful for serological diagnosis of RSV infections, they offer high degree of sensitivity, specificity and can be used to differentiate antigen into their respective immunoglobulin classes.

RSV IGM ELISA KIT CONTENT

All reagents supplied need to be stored at 2 °C – 8 °C, unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date.

  • RSV antigen coated microtiter strips.
  • Calibrators (A-D): Negative, Cut-Off, Weak Positive and Positive Controls.
  • Enzyme Conjugate.
  • Sample Diluent.
  • TMB Substrate.
  • Washing Buffer (10x).
  • Stop Solution.

SENSITIVITY

The minimum detection sensitivity level of IgM antibodies to respiratory syncytial virus (RSV IgM) using current human RSV-IgM ELISA kit was 1.7 U/ml. The dynamic range for this assay is 1.0 – 150.0 U/ml.

ASSAY CHARACTERISTICS

– RSV ELISA: IgM
– Intra-Assay-Precision: 10.1 %
– Inter-Assay-Precision: 6.8 %
– Inter-Lot-Precision: 1.0 – 8.7 %
– Analytical Sensitivity: 1.70 U/mL
– Recovery: 89 – 104 %
– Linearity: 83 – 121 %
– Cross-Reactivity: No cross-reactivity to Adenovirus, Influenza A and Parainfluenza 1/2/3.
– Interferences: No interferences to hemoglobin up to 8.0 mg/mL, triglycerides up to 5.0 mg/mL and bilirubin up to 0.3 mg/mL.
– Clinical Specificity: 100 %
– Clinical Sensitivity: 100 %

REFERENCES

  1. Application of ELISA for IgM, IgA and antigen detection for rapid diagnosis of respiratory-syncytial virus infections: a comparative study. Clin Diagn Virol. (1995) 3 (1): 17-27. Varsano N., et al.
  2. [Evaluation of serum specific IgM detection in diagnosis of respiratory viral infections in children]. Zhonghua Er Ke Za Zhi. (2012) 50 (6): 440-4. Chinese. Song Q.W., et al.
  3. Atopy does not predispose to RSV bronchiolitis or post-bronchiolitic wheezing. Br Med J (Clin Res Ed). (1981) 282 (6282): 2086-8. Sims D.G., et al.
  4. Detection of an immunoglobulin M response in the elderly for early diagnosis of respiratory-syncytial virus infection. J Clin Microbiol. (1988) 26 (5): 808-11. Vikerfors T., et al. 

ADDITIONAL INFORMATION

  • Full Name: Respiratory Syncytial Virus (RSV) IgM ELISA Kit
  • Reactivity: Human
  • Sample Type: Plasma, Serum
  • Sensitivity: 1.7 U/ml

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