RSV Rapid RNA

LAB495

RSV, respiratory syncytial virus

 

 

To collect a nasopharyngeal swab sample, carefully insert the swab into the nostril exhibiting the most visible drainage, or the nostril that is most congested if drainage is not visible. Pass the swab directly backwards without tipping the swab head up or down. The nasal passage runs parallel to the floor, not parallel to the bridge of the nose. Using gentle rotation, insert the swab into the anterior nare parallel to the palate advancing the swab into the nasopharynx, leave in place for a few seconds, and then slowly rotate the swab as it is being withdrawn.
To ensure proper collection, the swab should be passed a distance that is halfway of that from the nose to the tip of the ear. This is about half the length of the swab. DO NOT USE FORCE while inserting the swab. The swab should travel smoothly with minimal resistance; if resistance is encountered, withdraw the swab a little bit without taking it out of the nostril. Then elevate the back of the swab and move it forward into the nasopharynx.
Elute the swab into a blue viral transport media by rotating the swab head in the liquid for 10 - 20 seconds, within 1 hour of sample collection. Remove the swab and discard. If immediate testing is not possible, eluted swab samples can be held at room temperature (15-30°C) for up to eight (8) hours prior to testing. If the eluted swab sample will be held longer than eight (8) hours, it must be refrigerated at 2-8°C and tested within 24 hours from the time of sample collection. If needed, transport the sample at 2-8°C in a leak-proof container.

Direct nasopharyngeal swabs should be tested as soon as possible after collection. If immediate testing is not possible, a direct nasopharyngeal swab can be held in its original package at room temperature (15-30°C) for up to two (2) hours prior to testing. If a direct nasopharyngeal swab specimen will be held longer than two (2) hours, it must be refrigerated at 2-8°C and tested within 24 hours from the time of sample collection.
If the transport of nasopharyngeal swab samples is required, the transport media listed below were tested and are acceptable for use in Alere™ i RSV. Elute the swab into 0.5 to 3.0 mL of saline or viral transport media by rotating the swab head in the liquid for 10 - 20 seconds, within 1 hour of sample collection. Remove the swab and discard. If immediate testing is not possible, eluted swab samples can be held at room temperature (15-30°C) for up to eight (8) hours prior to testing. If the eluted swab sample will be held longer than eight (8) hours, it must be refrigerated at 2-8°C and tested within 24 hours from the time of sample collection. If needed, transport the sample at 2-8°C in a leak-proof container.

Transport Media:
Amie’s Media
Dulbecco’s Modified Eagles Medium (DMEM)
M4 Media
M4-RT Media
M5 Media
M6 Media
Phosphate Buffered Saline
Saline
Tryptose Phosphate Broth
Veal Infusion Broth
Universal Transport Media
Starplex Multitrans Media
Vircell Media

Refrigerated 2-8°C

room temperature (15-30°C) (2) hours
refrigerated (2-8°C)  24 hours

Calcium alginate and Puritan Purflock® Ultra flocked swabs are not suitable for use in this assay.

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The performance of the Alere™ i RSV was evaluated using the procedures provided in this package insert only. Modifications to these procedures may alter the performance of the test.
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Alere™ i RSV performance depends on viral RNA load and may not correlate with cell culture performed on the same specimen. Viral nucleic acid may persist in vivo, independent of virus viability. Detection of analyte target(s) does not imply the corresponding virus(es) are infectious, or are the causative agents for clinical symptoms.
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There is a risk of false negative results due to the presence of sequence variants in the viral targets of the assay. If the virus mutates in the target regions, RSV viruses may not be detected or may be detected less efficiently. Additionally, if the sequence variant occurs in the target sequence recognized by the fluorescently-labeled molecular beacon an invalid assay may result.
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False negative results may occur if a specimen is improperly collected, transported or handled. False negative results may occur if inadequate levels of viruses are present in the specimen.
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Mucin may interfere with RSV detection at levels greater than 0.0625% w/v.
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This test is not intended to differentiate RSV subtypes. If differentiation of specific RSV subtypes is needed, additional testing, in consultation with state or local public health departments, is required.
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Negative results do not preclude infection with RSV and should not be the sole basis of a patient treatment decision.
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This test has not been evaluated for patients without signs and symptoms of respiratory infection.
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Cross-reactivity with respiratory tract organisms other than those tested in the Analytical Specificity Study may lead to erroneous results.
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This assay has not been evaluated for immunocompromised individuals.
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The test is a qualitative test and does not provide the quantitative value of detected organism present.
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Positive and negative predictive values are highly dependent on prevalence. The assay performance was established during the 2015 to 2016 respiratory season. The positive and negative predictive values may vary depending on the prevalence and population tested.

Negative for RSV viral RNA

Respiratory Syncytial Virus (RSV) is the single most important cause of severe respiratory illness in infants and young children and the major cause of infantile bronchiolitis. It is the most frequent cause of hospitalization of infants and young children in industrialized countries. In the USA alone, 85,000 to 144,000 infants with RSV infections are hospitalized annually, resulting in 20% to 25% of pneumonia cases and up to 70% of bronchiolitis cases in the hospital. Global RSV disease burden is estimated at 64 million cases and 160,000 deaths every year.1
RSV disease includes a wide array of symptoms, from rhinitis and otitis media to pneumonia and bronchiolitis. Spread of the virus from contaminated nasal secretions occurs via large respiratory droplets, and close contact with an infected individual or contaminated surface is required for transmission.
RSV is also a significant problem in the elderly, in persons with cardiopulmonary diseases and in immunocompromised individuals. Rates of RSV infection in nursing homes in the USA are approximately 5% to 10% per year with a 2% to 8% case fatality rate, amounting to approximately 10,000 deaths per year among persons >64 years of age.1