Legionella Antigen Rapid Test

Intended Use:

Legionella Antigen Rapid Test is an in-vitro rapid immunochromatographic assay for the qualitative detection of Legionella pneumophila antigen (L. pneumophila antigen) in urine specimens from patients with symptoms of pneumonia. It is intended to aid in the presumptive diagnosis of Legionella infection (Legionnaires' disease) caused by L. pneumophila in conjunction with culture and other methods.

Materials

● Device

● Instructions for use

Specimen Collection and Storage

● Legionella Antigen Rapid Test is intended for use with human urine specimens only.

● Although urine specimens from any time of day can be used, first morning urine specimens are preferred as they contain the highest concentration of Legionella pneumophila sg 1 antigen.

● Turbid specimens should be centrifuged, filtered, or allowed to settle and only the clear supernatant should be used for testing.

● Urine specimens must be collected in clean, dry containers.

● Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. Specimens may be stored at 2-8°C for up to 48 hours. For long term storage, specimens should be kept below 20°C.

● Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.

● If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.

Procedure

Do not remove device test from pack until test sample has reached room temperature. Bring patient urine and/or liquid urine control(s) to room temperature (15-30℃/59-86°F)

1.Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results the assay should be performed within one hour.

2.Add 2 drops of specimen (approximately 80 µL) directly into the specimen well (S) and start the timer.

Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.

As the test begins to work, color will migrate across the result area in the center of the device.

3.Wait for the colored band(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 20 minutes.

NOTE: Low L. pneumophila antigen concentrations may produce very weak T lines after a prolonged period of time. Therefore, do not interpret the result after 20 minutes.

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