Quidel Sofia™ RSV FIA Immunofluorescence Kit

Includes

RSV FIA 25-test Kit Contents:

• Individually Packaged Cassettes (25): Mouse monoclonal anti-RSV antibodies
• Reagent Tubes (25): Lyophilized buffer with detergents and reducing agents
• Reagent Solution (25): Vials with salt solution
• Sterile Nasopharyngeal Swabs (25)
• Large, Pink Fixed Volume Pipettes (25)
• Small, Clear Fixed Volume Pipettes (25)
• RSV Positive Control Swab (1): Swab is coated with non-infectious RSV antigen
• Negative Control Swab (1): Swab is coated with heat-inactivated, non-infectious Streptococcus C antigen
• Package Insert (1)
• Quick Reference Instructions (1)
• QC Card (located on kit box)
• Printer Paper (1)

For rapid qualitative detection of respiratory syncytial virus (RSV) nucleoprotein antigens

 

• Use with Sofia Analyzer only
• Test nasopharyngeal swab and nasopharyngeal aspirate/wash specimens taken directly from symptomatic patients less than 19 years of age
• When run in conjunction with Sofia Influenza A+B FIA, a single specimen may be used for both tests
• Accurate results within 15 mins.
• 25 tests per kit

 

Applications:   IVD

CLIA Complexity: This test is CLIA moderately complex for pediatric patients 7 to less than 19 years of age. It is CLIA waived for children less than 7 years of age.

Certifications

CE Marked; CLIA Complexity: Waived

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Clia Complexity

Waived

Detectable Analytes

Respiratory Syncytial Virus (RSV) Antigen

Sample Type

Nasopharyngeal swab and nasopharyngeal aspirate/wash specimens

Type

Sofia™ RSV FIA Immunofluorescence Test Kit

For Use With (Application)

IVD

Includes

Individually packaged cassettes 25, reagent tubes 25, reagent solution 25, sterile nasopharyngeal swabs 25, large, pink fixed volume pipettes 25, small, clear fixed volume pipettes 25, RSV positive control swab 1, negative control swab 1, package insert 1, quick reference instructions 1, QC card, printer Paper 1

Quantity

1 x 25 Tests

Test Time

>15 min.