PRODUCTS


INTENDEDUSE

The AMPER COVID-19 Antigen Rapid Testing Kit(Colloidal Gold) is a colloidal gold-based lateral flow immunoassay, intendedfor the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2in nasopharyngeal swab (NPS) and oropharyngeal swab (OPS) specimens fromindividuals who are suspected of COVID-19 by their healthcare provider. Testingis limited to laboratories certified under the Clinical Laboratory ImprovementAmendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements toperform moderate complexity and high complexity.

 

Results are for the identification of SARS-CoV-2nucleocapsid protein antigen. Antigen is generally detectable in nasopharyngealswab (NPS) and oropharyngeal swab (OPS) specimens during the acute phase ofinfection. Positive results indicate the presence of viral antigens, butclinical correlation with patient history and other diagnostic information isnecessary to determine infection status. Positive results do not rule outbacterial infection or co-infection with other viruses. The agent detected maynot be the definite cause of disease. Laboratories within the United States andits territories are required to report all positive results to the appropriatepublic health authorities.

 

Negative results should be treated as presumptive,and do not rule out SARS-CoV-2 infection and should not be used as the solebasis for treatment or patient management decisions, including infectioncontrol decisions. Negative results should be considered in the context of apatient’s recent exposures, history, and the presence of clinical signs andsymptoms consistent with COVID-19, and confirmed with a molecular assay, ifnecessary, for patient management.

 

The AMPER COVID-19 Antigen Rapid Testing Kit(Colloidal Gold) is intended for use by medical professionals or trainedoperators who are proficient in performing tests and trained clinicallaboratory personnel or individuals trained in point of care settings.



specifications:

The AMPER COVID-19 Antigen Rapid Testing Kit (Colloidal Gold) has two specifications: 1 test per box and 25 tests per box as listed in the followingTable.


    Table 1. Specifications

Catalogue number

MU00301

MU00325

Kit Size (test)

1

25

Component

sample extraction buffer

1

25

sample bottle with lid

1

25

test cartridge*

1

25

Desiccant*

1

25

IFU leaflet

1

1

* Transfer pipette and desiccant arepackaged inside the test cassette pouch

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