Product Datasheet/Brochure

Page 3 – Sang Joon Han, Access Bio, Inc.
other viruses. The agent detected may not be the definite cause of disease. Individuals who test
positive with your product 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 for
patient management, may be performed if necessary. 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 COVID19. For serial testing programs, additional confirmatory testing
with a molecular test for negative results may be necessary, if there is a high likelihood of
COVID-19, such as, an individual with a close contact with COVID-19 or with suspected
exposure to COVID-19 or in communities with high prevalence of infection. Additional
confirmatory testing with a molecular test for positive results may also be necessary, if there is a
low likelihood of COVID-19, such as in individuals without known exposures to COVID-19 or
residing in communities with low prevalence of infection.
Individuals who test negative and continue to experience COVID-like symptoms of fever, cough
and/or shortness of breath may still have SARS-CoV-2 infection and should seek follow up care
from their healthcare provider.
Individuals should provide all results obtained with this product to their healthcare provider for
public health reporting. All healthcare providers will report all test results they receive from
individuals who use the authorized product to relevant 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 (LIVD) Test Code Mapping for SARS-CoV-2
Tests provided by CDC.
Your product is performed using anterior nasal samples from individuals aged 14 years or older
or adult collected anterior nasal samples from individuals age 2 years or older. The individual
using your product has the option to follow the CareStart COVID-19 Antigen Home Test User
Instructions provided with the kit or follow step-by-step mobile application-based instructions
by downloading theon/go App” onto a compatible smartphone.
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When using your product the
individual unpacks the tray containing all the test components, before removing the test device
from its pouch and placing it on a flat clean surface. The extraction vial is then opened and
inserted into the tray in an upright position. The swab is then removed from its pouch and the
individual collects an anterior nasal swab sample by inserting the swab into the nostril and
rotating at least 5 time for a total of 15 seocnds before repeating in the second nostril. The swab
is then inserted into the extraction vial and rotated vigorously at least 5 times before being
removed and the vial capped. The contents of the extraction vial is then mixed before three drops
are applied to the sample well of the test device. When the anterior nasal swab specimen
migrates in the test strip, SARS-CoV-2 viral antigens present in the sample bind to anti-SARS-
CoV-2 nucleocapsid protein antibodies conjugated to indicator and capture particles in the test
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Compatible smart phone includes Apple iPhone running Operation System (iOS) 13 or later versions of the OS,
and Android Phones running Android10 or later versions. Additional smart phone models as may be requested, and
for which you receive appropriate authorization, in accordance with Condition L. below.