RSV Antigen Rapid Test – EZER™ Diagnostic Kit
The EZER Respiratory Syncytial Virus Antigen Rapid Test detects RSV nucleoprotein antigen in a nasopharyngeal swab, a throat swab or a nasal aspirate, by lateral flow immunoassay read by eye in 15 minutes. The manufacturer reports an overall agreement with the reference method of 97.7 per cent on 1112 nasal aspirates, 97.9 per cent on 329 nasopharyngeal swabs and 98.7 per cent on 315 throat swabs.
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This kit in detail
- RSV nucleoprotein antigen in nasopharyngeal swab, throat swab or nasal aspirate
- Result in 15 minutes, read by eye, no instrument needed
- Overall agreement 97.7 to 98.7 per cent, depending on sample type
- Internal procedural control on every device
- Samples may be held at 2 to 8 °C for up to 48 hours
- 20 tests per kit with swabs, extraction tubes and nozzles, REF P211004
The EZER Respiratory Syncytial Virus Antigen Rapid Test is used in the rapid diagnosis of RSV infection, where the result is needed during the consultation rather than after a laboratory run.
Performance
The manufacturer reports, against the reference method: for nasal aspirate (n = 1112) a positive agreement of 96.19 per cent and a negative agreement of 98.47 per cent, overall 97.66 per cent; for nasopharyngeal swab (n = 329) 97.35 and 98.15 per cent, overall 97.87 per cent; and for throat swab (n = 315) 97.92 and 99.09 per cent, overall 98.73 per cent, each with the 95 per cent confidence interval stated in the IFU.
Procedure
The sample is taken with the supplied swab, extracted in the extraction tube and applied to the device with the nozzle. The result is read at 15 minutes and is not valid after 30 minutes. Every device carries an internal procedural control: the control line at position C shows that the reagents worked. Samples may be kept at 2 to 8 °C for up to 48 hours before testing. The kit is stored at 2 to 30 °C and must not be frozen. Reading is visual; no reader is named.
Interpretation
An antigen test is less sensitive than PCR, particularly in adults and later in the course of illness, when viral load falls. A negative result in a patient with a matching clinical picture therefore does not exclude RSV.
Datasheets and regulatory documentation
Everything your quality team needs for evaluation and procurement.
Frequently paired with this kit
Other assays and instruments lab teams add alongside the RSV Antigen Rapid Test – EZER™ Diagnostic Kit.
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