Clinitest - Rapid Test Kit Antigen Detection At-Home OTC COVID-19 Test Anterior Nasal Swab Sample 5 Tests per Kit - 11556711
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This product may require 1-3 business days to process and prepare for shipping.
- The CLINITEST At-Home OTC COVID-19 Test is only for use under an FDA EUA: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
- Ships with minimum 30 Days Dating
- The CLINITEST At-Home OTC COVID-19 Test is a lateral flow chromatographic immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2
- This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first 7 days of symptom onset
- This test is also authorized for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom onset
- This test is also authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests
- Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen; antigen is generally detectable in anterior nasal (nares) swabs during the acute phase of infection
- Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status
- Positive results do not rule out bacterial infection or co-infection with other viruses
- Individuals who test positive with CLINITEST Rapid COVID-19 Antigen Self-Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary
- Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed
- 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
- Individuals should provide all results obtained with this product to their healthcare provider for public health reporting
- 86.5% Sensitivity; 99.3% Specificity
- Qualitative; visually interpreted, no instrument required
Stock Number : 1203770
Manufacturer # : 11556711
Brand : Clinitest
Manufacturer : Siemens
Country of Origin : China
Application : Rapid Test Kit
Contents 1 : (5) Test Devices, (5) Sterile Swabs, (5) Extraction Tubes with Buffer and Tips, Instructions for Use
HCPCS : U0002
Number of Tests : 5 Tests per Kit
Product Dating : McKesson Acceptable Dating: we will ship >= 30 days
Reading Type : Visual Read
Sample Type : Anterior Nasal Swab Sample
Test Format : Cassette Format
Test Method : Lateral Flow Chromatographic Immunoassay
Test Name : At-Home OTC COVID-19 Test
Test Type : Antigen Detection
Time to Results : 15 Minute Results
UNSPSC Code : 41116205
CLINITEST COVID-19 RAPID ANTI GEN OTC (5/KT 170KT/CS)