RSV Pre-F ELISA Kit

Sample

Serum, plasma, or other biological fluids

Species Reactivity

Human

Detection Method

iELISA

Intended Use

Human Anti- Respiratory Syncytial Virus Fusion Protein (RSV-F) IgG is an indirect ELISA suitable for detecting anti-RSV-F protein IgG in serum or plasma in vaccinated samples. Other biological fluids, including tissue culture medium, may be validated for use.
This immunoassay is suitable for:
1. Determining immune status relative to non-immune controls
2. Assessing efficacy of vaccines, including dosage, adjuvantcy, route of immunization, and timing
3. Qualifying and/or standardizing vaccine batches/protocols
The kit contains no virus or virus derived antigens. For research use only (RUO). Not for diagnosis, cure, or prevention of the disease.

Contents of Kit

1. Wash Solution Concentrate (100×), 10ml
2. Sample Diluent Concentrate (20×), 10ml
3. Anti-Human IgG-HRP Conjugate Concentrate (100×), 0.15ml
4. RSV-F Coated Strip Plate, 8-well strips (12), Coated with purified recombinant RSV-F and post-coated with stabilizers.
5. Anti-RSV-F Calibrators: 1 U/ml, 2.5 U/ml, 5 U/ml, 10 U/ml. 0.65 ml each. Four (4) vials, each containing anti-RSV-F; in buffer with antimicrobial as stabilizers.
6. Anti-RSV-F Positive Control, 0.65 ml. Serum with anti-RSV-F reactivity; [Value range on label]
7. Low NSB Sample Diluent, 30 ml Buffer with protein, detergents and antimicrobial as stabilizers. Use as is for sample dilution.
8. TMB Substrate, 12 ml. Chromogenic substrate for HRP containing TMB and peroxide.
9. Stop Solution, 12 ml. Dilute sulfuric acid.

Storage

The microtiter well plate and all other reagents, if unopened, are stable at 2-8°C until the expiration date printed on the box label.
Stabilities of the working solutions are indicated under Reagent Preparation.

General Description

Respiratory Syncytial Virus (RSV) is a leading cause of severe respiratory infection in infants and children. RSV is a respiratory pathogen that infects human and chimpanzees. It is the most common pathogen leading to hospitalization in young children up to the age of 5. RSV Infection may result from either direct or indirect contact with oral or nasal secretions from an infected person. Specific diagnostic tests for confirming RSV infection include Culture, Antigen-revealing techniques, Polymerase chain reaction (PCR) assay, and serology (Antigen or antibody tests by ELISA).
RSV is an enveloped, nonsegmented, negative-sense RNA virus (~15 Kb) that encodes major viral proteins (G, F, and SH). Matrix protein (M) and four proteins associated with the genomic RNA form the viral nucleocapsid (N, P, L, and M2) open reading frame 1 [M2 ORF1]). M2 ORF-2 is a second, distinct protein transcribed from the M2 gene, which has defined properties in transcriptional regulation. Finally, two proteins (NS1 and NS2) are nonstructural viral products that accumulate in infected cells but are present in only trace amounts in mature virions.
Therapeutics & Vaccines: High risk infants can be treated with a neutralizing, humanized antibody to RSV (palivizumab or Synagis®) to reduce the risk of severe RSV. No approved vaccine available. A formalin-inactivated vaccine (FI-RSV) showed poor immunity. Recombinant vaccine that is suitable for intranasal instillation is being tested in the chimpanzee.