Absorbent Packet and 0.75 mL Developer Solution Vial
HCPCS
(5) Test Stands
Number of Tests
Instructions for Use
Product Dating
Quick Reference Guide
Purchase Program Type
U0002
Reading Type
25 Tests
Sample Type
SLI Medical Acceptable Dating: we will ship >= 90 days
Specialty
Visual Read
Test Format
Nasal Swab Sample
Test Kit Type
Test Device Format
Test Method
Lateral Flow Immunoassay
Test Name
COVID-19 Rapid Test Pro
Test Type
Antigen Detection
Time to Results
30 to 40 Minute Time to Results
UNSPSC Code
41116205
Features
The InteliSwab COVID-19 Rapid Test Pro is 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
The InteliSwab™ COVID-19 Rapid Test Pro is a single-use lateral flow immunoassay with an integrated swab
intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal samples from individuals 18 years or older when the sample is self-collected or in individuals 2 years or older when the sample is collected by an adult or healthcare provider
The test is authorized for individuals who are suspected of COVID-19 by their healthcare provider within 7 days of symptom onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests
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
high or waived complexity 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
Positive results indicate that viral antigens have been detected
but clinical correlation with patient history and other diagnostic information is necessary to determine infection status; positive results do not exclude bacterial infection or coinfection with other viruses
Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities in accordance with local
state
and federal requirements using appropriate LOINC and SNOMED codes
as defined by the Laboratory In Vitro Diagnostics (LVID) Test Code Mapping for SARS-CoV-2 Tests provided by CDC
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
Negative results should be considered in the context of an individual’s recent exposures
history and the presence of clinical signs and symptoms consistent with COVID-19
The InteliSwab™ COVID-19 Rapid Test Pro is intended for use by medical professionals or trained operators who are proficient in performing tests and trained clinical laboratory personnel or individuals trained in POC settings
TEST, COVID-19 RAPID INTELISWAB PROFESSIONAL KIT (25/BX) D/S
