Rapid Check™ RSV Antigen Test
Supplier: Germaine Laboratories
Rapid, qualitative detection of respiratory syncytial virus fusion protein in nasopharyngeal swabs/nasal aspirate specimens in patients less than 6 years and over 60. Intended as a simple and effective aid in the rapid laboratory diagnosis of acute respiratory syncytial virus infection in patients with consistent symptoms.
- Rapid detection and patient management
- RSV infection results available in 15 minutes
- Positive and negative controls included
- Nasopharyngeal swabs included with each kit
- Various sample types
- Nasopharyngeal swab and nasal aspirates-from symptomatic patients less than 6 years and over the age of 60
- CUA waived testing at the point-of-care for use with minimally trained healthcare professionals
- Transport medium compatibility allows for analysis of preserved or transported specimens
- External quality controls included facilitate routine quality inspection
- Shelf life spans viral aeasonality; 24 months from date of manufacture at room temperature storage
The Rapid Check™ RSV antigen test is intended for the rapid, qualitative detection of respiratory syncytial virus fusion protein directly from nasopharyngeal swab, and nasal aspirate specimens in children less than 6 years and adults over the age of 60. RSV infection results available in 15 minutes. The test is intended for use as an aid in the rapid laboratory diagnosis of acute respiratory syncytial virus infection in patients with symptoms consistent with RSV infection. It is recommended that negative test results be confirmed by cell culture.
Premier test performance:
Positive percent agreement: 93.9%
Negative percent agreement: 97.7%
Nasopharyngeal swab and nasal aspirates. Refer to the package insert for additional performance claims.
Certifications: CLIA waived.
Delivery information: Kit includes 20 individually packaged test devices; 1 R1 (extraction reagent solution) 2 ml; 20 extraction tubes; 40 disposable pipettes; 1 PC (positive control reagent) 1.0 ml; 1 NC (negative control reagent) 1.0 ml; instructions for use; swabs with each kit.
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