Description

The EASENDER SARS-CoV-2 & Respiratory Syncytial Virus & Flu A ＆ Flu B Antigen Rapid Test Kit is a rapid, qualitative in vitro diagnostic tool designed for the qualitative detection of Flu A＆ Flu B & Respiratory Syncytial Virus & Adenovirus antigens in Nasal Swab and nasal aspirate samples

This kit is intended to facilitate the prompt diagnosis of SARS-CoV-2 & Respiratory Syncytial Virus & Flu A ＆ Flu B infections. It is important to note that the results obtained from this test are preliminary in nature. Consequently, any positive findings should be corroborated through further confirmatory testing methodologies and comprehensive clinical assessment to ensure accurate diagnosis and appropriate clinical management.

Feature

Easy to use: Simple operation without cumbersome steps.

Fast: Get results in within 15 minutes.

Accurate: High sensitivity, detection 4 items in a testing.

SAMPLE COLLECTION

It is applicable to the diagnosis of the respiratory syncytial virus from the specimens of nasal swabs or throat swabs. Use freshly collected specimens for optimal test performance. Inadequate specimen collection or improper specimen handling may yield a false-negative result.

1.Nasal Swabbing: Completely insert the sterilized swab supplied in this kit into the nasal basin, and swab several times to collect the epidermal cells of the mucus. It is recommended to collect specimen from nasal basin for more accurate results.

2.Throat Swabbing: Deeply insert the sterilized swab into the throat and swab several times to collect the epidermal cells of the mucus. Caution must be paid to avoid the swab to be contaminated with saliva.

3.Specimen collected may be stored for 1 days at 2-8℃ if not tested within 1 hours. For long term storage, specimens should be kept below -20℃.

SAMPLE PREPARATION PROCEDURE

1)Nasal /pharyngeal Swabs

Insert swab with collected sample into extraction tube containing 10 drops (about 500μl) of sample extraction buffer. Squeeze the swab several times by compressing the outside walls of the tube end against the swab to mix well. . Leave the swab in the Reagent Tube for one minute. Finally squeeze the swab to make most of the solution stays in the extraction tube and remove the swab. Use extraction solution as test sample.

2)Nasal Aspirate Fluids

Add 10 drops of sample extraction buffer into extraction tube ，then add about 500μl of the nasal aspirate fluids into extraction tube and mix well. Use extraction solution as test sample.

TEST PROCEDURE

Allow the test device, test sample and buffer to equilibrate to room temperature (15-30°C) prior to testing.

1)Remove test device from the sealed pouch just prior to the testing and lay flat on work bench.

2)Insert a tube tip into the sample extraction tube tightly.

3)Reverse the sample extraction tube, and add 3 drops (about 100μl) of test sample by squeezing the extracted solution tube into the sample window.

4)Read the result at 15 minutes. Do not interpret the result after 20 minutes.

Interpret the result

LIMITATIONS OF TEST

1） The Flu A＆Flu B&Respiratory Syncytial Virus&Adenovirus Antigen Rapid Test (Colloidal Gold Method) is an acute-phase screening test for qualitative detection.

2）Sample collected may contain antigen titles below the reagent's sensitivity threshold, so a negative test result does not exclude infection with Respiratory Syncytial Virus

3）The Flu A＆Flu B&Respiratory Syncytial Virus&Adenovirus Antigen Rapid Test (Colloidal Gold Method) detects both viable and non-viable Respiratory Syncytial Virus antigen.  Test performance depends on antigen load in the sample and may not correlate with cell culture performed on the same sample.  A positive test does not rule out the possibility that other pathogens may be present.  Therefore, the results must be compared with all other available clinical and laboratory information to make an accurate diagnosis.

4）Performance of the test has not been established for monitoring antiviral treatment of Respiratory Syncytial Virus