SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test (Nasopharyngeal Swab)

Principle	Chromatographic Immunoassay
Format	Cassette
Specimen	Nasopharyngeal Swab
Certificate	CE
Reading Time	15 minutes
Pack	20 T
Storage Temperature	2-30°C
Shelf Life	2 Years

The SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid protein, Influenza A, Influenza B, Respiratory Syncytial Virus(RSV) and Adenovirus antigens present in human nasopharynx. For professional in vitro diagnostic use only

INTENDED USE

The SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid protein, Influenza A, Influenza B, Respiratory Syncytial Virus(RSV) and Adenovirus antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2/Influenza/RSV/Adenovirus infection in conjunction with clinical presentation and the results of other laboratory tests.

Results are for the detection of SARS-CoV-2, Influenza A+B, RSV and Adenovirus antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out other bacterial/viral infection. The agent detected may not be the definite cause of disease.

Negative results do not preclude SARS-CoV-2/Influenza A+B/RSV/Adenovirus infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with SARS-CoV-2, Influenza A+B, RSV and Adenovirus.

REAGENTS

The test contains anti-SARS-CoV-2, anti-Influenza A, anti-Influenza B, anti-RSV and anti-Adenovirus as the capture reagent, anti-SARS-CoV-2, anti-Influenza A, anti-Influenza B, anti-RSV and anti-Adenovirus as the detection reagent.

SPECIMEN COLLECTION, TRANSPORT AND STORAGE

Specimen Collection

1. Insert a sterile swab into the nostril of the patient, reaching the surface of the posterior nasopharynx.

2. Swab over the surface of the posterior nasopharynx 5-10 times.

3. Withdraw the sterile swab from the nasal cavity and avoid excess volume and highly-viscous nasopharyngeal discharge.

Specimen Transport and Storage

Specimens should be tested as soon as possible after collection. If swabs are not been processed immediately, it is highly recommended the swab specimen is placed into a dry, sterile and tightly sealed plastic tube for storage. The swab specimen in dry and sterile condition is stable for up to 24 hours at 2-8 °C.

【DIRECTIONS FOR USE】

Allow the test, extracted specimen and/or controls to equilibrate to room temperature (15-30 °C) prior to testing.

1. Remove the test cassette from the sealed foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.

2. Invert the specimen collection tube and add 3 drops of the extracted specimen to each of the specimen well(S) respectively and then start the timer.

3. Wait for the colored line(s) to appear. Read the result at 15 minutes. Do not interpret the result after 20 minutes.

SARS-CoV-2/RSV/Adenovirus POSITIVE:* Two colored lines appear in the SARS-CoV-2/RSV/Adenovirus window. One colored line should be in the control region (C) and another colored line should be in the test region (T). Positive result in the test region indicates detection of SARS-CoV-2/RSV/Adenovirus antigens in the specimen.

Influenza A POSITIVE:* Two colored lines appear in the FLU window. One colored line should be in the control region (C) and another colored line should be in the Influenza A region(A). Positive result in the Influenza A region indicates that Influenza A antigen was detected in

the specimen.

Influenza B POSITIVE:* Two colored lines appear in the FLU window. One colored line should be in the control region (C) and another colored line should be in the Influenza B region (B). Positive result in the Influenza B region indicates that Influenza B antigen was detected in

the specimen.

Influenza A and Influenza B POSITIVE:* Three colored lines appear in the FLU window. One colored line should be in the control region (C) and two colored line should be in the Influenza A region (A) and Influenza B region (B). Positive result in the Influenza A region and Influenza B region indicates that Influenza A antigen and Influenza B antigen were detected in the specimen.

*NOTE: The intensity of the color in the test line region (T) will vary based on the amount of SARS-CoV-2 antigen, Influenza A and/or B antigen, RSV antigen, Adenovirus antigen present in the specimen. So any shade of color in the test region (T/B/A) should be considered positive.

NEGATIVE: One colored line appears in the control region (C). No apparent colored line appears in the test line region (T/B/A).

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

Tag:

Place of Origin:	China
Brand Name:	AllTest
Certification:	CE
Model Number:	IRT-545

Packaging Details:	20 T
Payment Terms:	T/T

Specimen:	Nasopharyngeal Swab	Format:	Cassette
Time:	15 Minutes	COLOR:	BLUE
Model:	IRT-545	Certificate:	CE
High Light:	Nasopharyngeal Swab Antigen Combo Rapid Test , Adenovirus Antigen Combo Rapid Test

	Hangzhou AllTest Biotech CO.,LTD
	#383, Qiaoxin Road, Xiasha Street, Qiantang Disctrict, Hangzhou, Zhejiang, P.R.China
	86-571-56267891
	selina.wu@alltests.com.cn

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