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USA EUA certificate COVID-19 Antigen test kits: result in 10 min
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USA EUA certificate COVID-19 Antigen test kits: result in 10 min
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For use under Emergency Use Authorization (EUA) only

For in vitro diagnostic use only

For prescription use only


COVID-19 Rapid Antigen Test

For Rapid Detection of SARS-CoV-2 Antigen

INSTRUCTIONS FOR USE

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IC04QS2021 | PI-2110400ENG | Rev A| July 2021

Contents

Intended Use .....................................................................................................................................................3

Summary and Explanation of the Test......................................................................................................3

Principles of the Procedure...........................................................................................................................4

Reagents and Materials Provided...............................................................................................................5

Chemical and Safety Information...........................................................................................................5

Materials Required but not Provided ....................................................................................................6

Precautions.........................................................................................................................................................6

Storage and Stability .......................................................................................................................................7

Quality Control ..................................................................................................................................................7

Internal Quality Control: .............................................................................................................................7

External Quality Control: ............................................................................................................................7

Specimen Collection, Handling, and Transport......................................................................................8

Test Procedure for Patient Swabs.............................................................................................................10

Result Interpretation.....................................................................................................................................11

Positive Result .............................................................................................................................................11

Negative Result...........................................................................................................................................11

Invalid Result................................................................................................................................................11

External Quality Control Test Procedure................................................................................................11

Limitations........................................................................................................................................................12

Conditions of Authorization for Laboratory and Patient Care Settings .......................................14

Performance Characteristics ......................................................................................................................15

Clinical Performance and Point-of-Care Use ....................................................................................15

Limit of Detection (Analytical Sensitivity)...........................................................................................17

Cross-reactivity (Analytical Specificity) and Microbial Interference...........................................17

High Dose Hook Effect .............................................................................................................................19

Endogenous Interfering Substances...................................................................................................19

Technical Support..........................................................................................................................................20

Symbols .............................................................................................................................................................20

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IC04QS2021 | PI-2110400ENG | Rev A| July 2021

Intended Use

The INDICAID™ COVID-19 Rapid Antigen Test is a lateral flow immunoassay

intended for the qualitative detection of nucleocapsid protein antigen from SARSCoV-2 in direct anterior nasal swab specimens from individuals who are suspected

of COVID-19 by their healthcare provider within the first five (5) days of symptom

onset. Anterior nasal swab specimens may be collected by a healthcare provider

(HCP) or self-collected (by individuals 18 years of age or older, under the supervision

of an HCP). Testing is limited to laboratories certified under the Clinical Laboratory

Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the

requirements to perform moderate complexity, high complexity, or waived tests.

This test is authorized for use at the Point of Care (POC), i.e., in patient care settings

operating under a CLIA Certificate of Waiver, Certificate of Compliance, or

Certificate of Accreditation.

The INDICAID™ COVID-19 Rapid Antigen Test does not differentiate between

SARS-CoV and SARS-CoV-2 viruses.

Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen.

Antigen is generally detectable in anterior nasal swabs 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 bacterial infection or coinfection with other viruses. The agent detected may not be the definite cause of

disease. Laboratories within the United States and its territories are required to

report all positive results to the appropriate public health authorities.

Negative results should be treated as presumptive and may be confirmed with a

molecular assay, if necessary, for patient management. Negative results do not rule

out SARS-CoV-2 infection and should not be used as the sole basis for treatment or

patient management decisions, including infection control decisions. 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 COVID-19.

The INDICAID™ COVID-19 Rapid Antigen Test is intended for use by trained clinical

laboratory personnel and medical and healthcare personnel in Point of Care (POC)

settings. The INDICAID™ COVID-19 Rapid Antigen Test is only for use under the

Food and Drug Administration’s Emergency Use Authorization.

Summary and Explanation of the Test

Coronaviruses are a large family of viruses that cause illness ranging from the

common cold to more severe diseases such as MERS and SARS-CoV. A novel

coronavirus (SARS-CoV-2) was discovered in December 2019 and has resulted in

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IC04QS2021 | PI-2110400ENG | Rev A| July 2021

millions of confirmed human infections worldwide. COVID-19, the disease brought

on by the virus, produces symptoms in infected patients that are similar to the

other viral respiratory diseases including fever, cough, and shortness of breath. The

median incubation time is estimated to be approximately 5 days with symptoms

estimated to be present within 12 days of infection.

The INDICAID™ COVID-19 Rapid Antigen Test is a non-invasive rapid point-of-care

diagnostic test for the qualitative detection of SARS-CoV-2 antigen in respiratory

specimens. Each INDICAID™ COVID-19 Rapid Antigen Test is single-use and can

analyze one anterior nasal swab sample. The total time required to perform one

test is approximately 20 minutes from clinical specimen collection to result.


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