accessbiodiagnstics RCHM-02071 Rapid Diagnostic Test for the Detection of SARS-CoV-2 Antigen Instruction Manual
- June 7, 2024
- accessbiodiagnstics
Table of Contents
RCHM-02071 Rapid Diagnostic Test for the Detection of SARS-CoV-2 Antigen
Antigen
Rapid Diagnostic Test for the Detection of
SARS-CoV-2 Antigen
RCHM-02071
For use under the Emergency Use Authorization (EUA) only For in vitro
diagnostic use only For prescription use only
Package Insert
(Instructions for Use)
Intended Use
The CareStartTM COVID-19 Antigen test is a lateral flow immunochromatographic
assay intended for the qualitative detection of the nucleocapsid protein
antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens
directly collected from individuals who are either suspected of COVID-19 by
their healthcare provider within first five 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. Results
are for the identification of the SARS-CoV-2 nucleocapsid protein antigen. The
antigen is generally detectable in nasopharyngeal or anterior nasal swab
specimens during the acute phase of infection. Positive results indicate the
presence of viral antigens, but the clinical correlation with patient history
and other diagnostic information is necessary to determine infection status.
Positive results do not rule out a bacterial infection or co-infection 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 results to the appropriate public 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 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, and
confirmed with a molecular assay, if necessary, for patient management. For
serial testing programs, additional confirmatory testing with a molecular test
for negative results may be necessary, if there is a high likelihood of SARS-
CoV-2 infection, 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 SARS-CoV-2
infection, such as in individuals without known exposures to SARS-CoV-2 or
residing in communities with low prevalence of infection. The CareStartTM
COVID-19 Antigen is intended for use in point of care settings and operated by
healthcare professionals or trained users specifically instructed in the use
of the CareStartTM COVID-19 Antigen and proper infection control procedures.
The CareStartTM COVID-19 Antigen is only for use under the Food and Drug
Administration’s Emergency Use Authorization.
Summary and Explanation of the Test
Since the first outbreak reported in December 2019, SARS-CoV-2 has spread
rapidly worldwide, and the disease it causes has been named “Coronavirus
Disease 2019” (COVID-19). Due to its highly contagious nature and global
health crises, SARS-CoV-2 has been designated as a pandemic by the World
Health Organization (WHO). SARS-CoV-2 continues to have devastating impacts on
healthcare systems and the world economy including the U.S. The CareStartTM
COVID-19 Antigen is a rapid (approximately 10 minutes) chromatographic
immunoassay for the direct detection of the presence or absence of SARS-CoV-2
antigens in the respiratory specimens taken from patients with signs and
symptoms who are suspected of COVID-19, or taken from asymptomatic individuals
being tested serially, as described in the authorized intended use. The test
is intended to be interpreted visually in both laboratory and near patient
testing environments without an instrument.
Principles of the Test
The CareStartTM COVID-19 Antigen test is a lateral flow immunochromatographic
assay for the detection of extracted nucleocapsid protein antigens specific to
SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly
collected from individuals who are suspected of COVID-19 by their healthcare
provider within the first five days of symptom onset, or who are asymptomatic
and undergoing serial testing, as described in the intended use.
Nasopharyngeal and anterior nasal swabs require a sample preparation step in
which the sample is eluted into the extraction buffer solution. Extracted swab
sample is added to the sample well of the test device to initiate the test.
When the swab sample migrates in the test strip, SARS-CoV-2 viral antigens
bind to anti-SARS-CoV-2 nucleocapsid protein antibodies conjugated to
indicator and capture particles in the test strip forming an immune complex.
The immune complex is then captured by the test line on the nitrocellulose
membrane as it migrates through the strip. Test results are interpreted at 10
minutes. The presence of two colored lines in the control line region “C” and
test line region “T” indicates COVID-19 positive. The presence of one colored
line in the control line region “C” indicates COVID-19 negative. No appearance
of a colored line in the control region “C” indicates an invalid test
Reagents and Materials Provided
Contents Name
Quantity (in a kit)
Description
Test device
20 each
Foil pouched test device containing one test strip which is encased in plastic device cassette.
Extraction vial / cap
2an0dvicaalsps
The extraction vial contains extraction buffer solution.
N(oarsnaal sopharyngeal) 20 each swab Positive control swab 1 each
Swabs for specimen collection. Recombinant SARS-CoV-2 nucleocapsid protein antigen is dried on the foam-tipped head.
Negative control swab 1 each Blank swab
Package insert
1 each Instructions for use
QInusticrukcRtieofenrse(nQcReI)
1 each Quick reference instructions
The following materials are needed but not provided: Pair of gloves Timer Biohazard or sharps container Micropipette
Warnings and Precautions
For prescription and in vitro diagnostic use only. This product has not been
FDA cleared or approved, but has been authorized by FDA under an Emergency Use
Authorization (EUA) for use by laboratories certified under the CLIA that meet
the requirements to perform moderate, high or waived complexity tests. This
product 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 emergency use of this product
is only authorized for the duration of the declaration that circumstances
exist justifying the authorization of emergency use of in vitro diagnostic
tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of
the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless
the declaration is terminated or authorization is revoked sooner. This product
has been authorized only for the detection of proteins from SARS-CoV-2, not
for any other viruses or pathogens. As with all diagnostic tests, all results
must be interpreted together with other clinical information available to the
physician. Immediately use after opening the test device in the pouch. In
order to obtain accurate results, the test must follow this package insert.
Excess blood or mucus on the swab specimen may interfere with test performance
and may yield a false-positive result. Avoid touching any bleeding areas of
the nasopharynx when collecting specimens. Do not interpret the test result
before 10 minutes and after 15 minutes starting the test. Inadequate or
inappropriate sample collection, storage, and transport can result in
incorrect results. If specimen storage is necessary, swabs can be placed into
extraction buffer for up to four hours. Specimens should not be stored dry. Do
not use if the test device package is damaged. Do not use the kit contents
beyond the expiration date. Do not eat, drink, or smoke in the area where the
specimens and kit contents are handled. Use appropriate precautions in the
collection, handling, storage, and disposal of patient samples and used kit
contents. Dispose of used contents as biohazardous wastes in accordance with
federal, state, and local requirements. Nitrile or latex gloves should be worn
when performing this test. If the extraction buffer contacts the skin or eye,
flush with copious amounts of water. The SARS-CoV-2 positive control swabs
have been prepared from recombinant viral proteins and do not contain
infectious material. Handle all specimens as though they contain infectious
agents. Observe established precautions against microbiological hazards
throughout the procedure and follow the standard procedures for proper
disposal of specimens. Reagents contain sodium azide, which is harmful if
inhaled, swallowed, or exposed to skin. Contact with acids produces a very
toxic gas. If there is contact with skin, wash immediately with plenty of
water. Sodium azide may react with lead and copper plumbing to form highly
explosive metal azides. On disposal, flush with a large volume of water to
prevent azide build-up. Do not interchange kit contents from different lots.
Do not re-use any contents in the kit as they are single-use only. For
additional information on hazard symbols, safety, handling and disposal of the
components within this kit, please refer to the Safety Data Sheet (SDS)
located at accessbio.net.
Storage and Stability
Store the test kit as packaged between 1 ~ 30°C. The reagents and materials in
the CareStartTM COVID-19 Antigen are stable until the expiration date printed
on the outer packaging. Do not use beyond the expiration date. The test device
must remain in the sealed pouch until use. Do not freeze any contents of the
kit.
Quality Control
Internal Quality Control:
The CareStartTM COVID-19 Antigen contains a built-in internal procedural
control that is included in the test device. A red-colored line appearing in
the control region “C” is designed as an internal procedural control. The
appearance of the procedural control line indicates that sufficient flow has
occurred, and the functional integrity of the test device has been maintained.
If the procedural control line does not develop in 10 minutes, the test result
is considered invalid and retesting with a new device is recommended. If the
internal procedural control line is still absent in the retest, please contact
the Technical Support at
+1-888-898-1270 (Available Hours: Mon.
to Fri.: 8 a.m. 5 p.m.) or TShelp@accessbio.net (24/7 available).
External Control:
External control is used to demonstrate that the test device and test
procedure perform properly. It is recommended that positive and negative
external control swabs are run once with every new lot, shipment, and each new
user. External positive and negative control swabs are provided in the kit.
The external control should be tested using the swab test procedure provided
in this package insert or the quick reference instruction card. If the
external control results are invalid, please contact the Technical Support at
+1-888-898-1270 (Available Hours: Mon.
to Fri.: 8 a.m. 5 p.m.) or TShelp@accessbio.net (24/7 available) before
testing patient specimens.
Specimen Collection and Handling
Acceptable specimen type for testing with the CareStartTM COVID-19 Antigen is
a direct nasopharyngeal and anterior nasal swab specimen. It is essential that
correct specimen collection and preparation methods be followed. Inadequate
specimen collection, improper specimen handling and/or transport may yield
false results; therefore, specimen collection requires specific training and
guidance due to the importance of specimen quality to obtain accurate test
results. Specimens are stable for 4 hours in extraction buffer. Refer to the
CDC Interim Guidelines for Collecting, Handling, and Testing Clinical
Specimens from Persons for Coronavirus Disease 2019 (COVID-19)
https://www.cdc.gov/coronavirus/2019-nCoV/lab/ guidelines-clinical-
specimens.html
Swab Sample Collection Procedure Nasopharyngeal Swab Collection
Procedural Notes
Process the test sample immediately after collection. Use only recommended
nasopharyngeal swab for specimen collection. Collect the specimen wearing
safety gloves to avoid contamination. Do not touch the tip (specimen
collection area) of the swab. Collect samples as soon as possible within 5
days of symptom onset.
1
Remove a nasopharyngeal swab from the pouch.
2
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3
Slowly rotate 3-5 times the swab over the surface of the posterior
nasopharynx.
4
Leave swab in place for several seconds to absorb secretions. Slowly remove
the swab from the nostril while rotating it.
Anterior Nasal Swab Collection Procedural Notes
Process the test sample immediately after collection. Use only provided or
recommended anterior nasal swab for specimen collection. Collect the specimen
wearing safety gloves to avoid contamination Do not touch the tip (specimen
collection area) of the swab. Collect samples as soon as possible within 5
days of symptom onset.
1
Remove a nasal swab from the pouch.
2
Insert the swab into one of patient’s nostrils up to 1 inch from the edge of
the nostril.
Description of Symbols
In vitro diagnostic medical device Indicates a medical device that is intended to be used as an in vitro diagnostic medical device. Consult instructions for use Indicates the need for the user to consult the instructions for use. Manufacturer Indicates the medical device manufacturer.
Batch code Indicates the manufacturer’s batch code so that the batch or lot can be identified. Do not re-use Indicates a medical device that is intended for one use, or uses on a single patient during a single procedure. Use by date Indicates the date after which the medical device is not to be used.
Positive control Indicates a control material that is intended to verify the results in the expected positive range. Negative control Indicates a control material that is intended to verify the results in the expected negative range. Catalog number Indicates the manufacturer’s catalog number so that the medical device can be identified.
Caution Indicates the need for the user to consult the instructions for use
for important cautionary information such as warnings and precautions that
cannot, for a variety of reasons, be presented on the medical device itself.
Date of manufacture Indicates the date when the medical device was
manufactured.
Temperature limit Indicates the temperature limits to which the medical device
can be safely exposed.
Do not use if the package is damaged Indicates a medical device that should not be used if the package has been damaged or opened. Contains sufficient for
Manufactured by: Access Bio, Inc. 65 Clyde Road, Suite A. Somerset, NJ 08873,
USA Tel: 732-873-4040 Fax:
732-873-4043 Email: info@accessbio.net
Website: www.accessbio.net
Technical Support in the U.S. Tel:
+1-888-898-1270 (Toll Free) Email:
TShelp@accessbio.net
MIntarnivuofaDcitaugrneodsftoicrs:, Inc. 2021 Santa Monica Blvd, #11 Santa Monica, CA 90404, USA Tel: 888-965-0301 Fax: 888-965-0302 Email: info@intrivo.com Website: www.intrivo.com
Document number: IFU-RCHM71-E Revision number: E Effective date: Apr. 15, 2021
3
Slowly roll the swab 5 times over the surface of the nostril. Using the same
swab, repeat this collection process in the other nostril. Take approximately
15 seconds to collect the specimen.
4
Slowly remove the swab from the nostril while rotating it.
Test Procedures Procedural Notes
Allow test devices, reagents, specimens, and/or controls to equilibrate to
room temperature (15~30°C) prior to testing. Remove the CareStartTM COVID-19
Antigen test device and extraction vial from its foil pouch immediately before
testing. The CareStartTM COVID-19 Antigen kit IS INTENDED to be used only with
a direct nasopharyngeal or anterior nasal swab specimen. The CareStartTM
COVID-19 Antigen kit IS NOT INTENDED for testing other liquid samples such as
nasal wash, aspirate samples or samples in viral transport media as results
can be compromised by over dilution.
Direct Swab Test Procedure
PEEL OFF
1 2 Peel off aluminum foil seal from the top of the extraction vial
Place the swab into the extraction vial. Rotate the swab vigorously
containing the extraction buffer
at least 5 times.
PUSH FIRMLY
CLICK
3 Remove the swab by rotating against the extraction vial while squeezing the sides of the vial to release the liquid from the swab. Properly discard the swab.
4 Close the vial with the provided cap and push firmly onto the vial.
TAP
90°
5 Mix thoroughly by flicking the bottom of the tube.
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Start the timer
7
Read and interpret the test result at 10 minutes. The test result should not
be read and interpreted after 15 minutes.
10 min
Warning
The false positive, false negative, or invalid results may occur if the test
is interpreted outside of the interpretation window.
Interpretation of Results
NOTE: The test results should be read and interpreted at 10 minutes after the
sample application and the reading and interpretation of the results should
not exceed 15 minutes. The test results should not be interpreted using any
instruments.
Positive: two distinct colored lines appear.
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NOTE: The color intensity in the test region will vary depending on the amount
of SARS-CoV-2 nucleocapsid protein antigen present in the sample. Any faint
colored line(s) in the test region(s) should be considered as positive.
Negative:
Onengearteivde-croeslourlet.d line only next to “C” indicates a
NOTE: Negative results should be treated as presumptive and confirmation with
a molecular assay, if necessary, for patient management, may be performed.
Invalid:
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Serial Testing Results Reporting
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COVID-19 or with suspected exposure to COVID-19 or in communities
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Limitations
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CONDITIONS of AUTHORIZATION for LABORATORY
The CareStartTM COVID-19 Antigen test Letter of Authorization, along with the
authorized Fact Sheet for Healthcare Providers, the authorized Fact Sheet for
Patients, and authorized labeling are available on the FDAwebsite:
https://www.fda.gov/medical-devices/coronavirus-disease -2019-covid-19
-emergency-use-authorizations-medical-devices/vitrodiagnostics-euas. However,
to assist clinical laboratories using the CareStartTM COVID-19 Antigen test
(“your product” in the conditions below), the relevant Conditions of
Authorization are listed below: A. Authorized laboratories1 using your product
must include with test result reports, all authorized Fact Sheets. Under
exigent circumstances, other appropriate methods for disseminating these Fact
Sheets may be used, which may include mass media. B. Authorized laboratories
using your product must use your product as outlined in the authorized
labeling. Deviations from the authorized procedures, including the authorized
instruments, authorized extraction methods, authorized clinical specimen
types, authorized control materials, authorized other ancillary reagents and
authorized materials required to use your product are not permitted. C.
Authorized laboratories that receive your product must notify the relevant
public health authorities of their intent to run your product prior to
initiating testing. D. Authorized laboratories using your product must have a
process in place for reporting test results to healthcare providers and
relevant public health authorities, as appropriate. E. Authorized laboratories
must collect information on the performance of your product and report to
DMD/OHT7-OIR/OPEQ/CDRH (via email: CDRH-EUA-Reporting@fda.hhs.gov) and ACCESS
BIO, INC. (Technical Support at
+1-888-898-1270 or
TShelp@accessbio.net) any suspected occurrence of false positive or false
negative results and significant deviations from the established performance
characteristics of your product of which they become aware. F. All operators
using your product must be appropriately trained in performing and
interpreting the results of your product, use appropriate personal protective
equipment when handling this kit, and use your product in accordance with the
authorized labeling. G. ACCESS BIO, INC., authorized distributors, and
authorized laboratories using your product must ensure that any records
associated with this EUA are maintained until otherwise notified by FDA. Such
records will be made available to FDA for inspection upon request.
1 The letter of authorization refers 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” as “authorized
laboratories.”
Performance Characteristics Clinical Performance Nasopharyngeal Swab
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November 2020 against an FDA Emergency Use Authorized RT-PCR molecular assay
as a comparator method. A total of three (3) POC investigational sites
throughout the U.S. participated in the study. To be enrolled in the study,
patients had to be presenting at the participating scCwtrOuiittVdheyrIinDiac-
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the comparator method. The second collected nasopharyngeal swab from the same
nostril was tested directly on the CareStartTM COVID-19 Antigen test to
demonstrate the agreement with the comparator method. Testing was performed by
six (6) operators with no laboratory experience and who were representative of
the intended users. Operators were only using the QRI for the test without any
training provided. A total of 180 nasopharyngeal swab specimens collected from
individual symptomatic patients (within 5 days of onset) were considered
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CareStartTM COVID-19 Antigen
Positive Negative
Total Positive Percent Agreement (PPA) Negative Percent Agreement (NPA)
Comparator
Positive
Negative
Total
30
1
31
2
147
149
32
148
180
93.75% (95% CI: 79.85% 98.27%)
99.32% (95% CI: 96.27% 99.88%)
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Patient Demographics
Age Group
5 Years of Age 6-21 Years of Age 22-59 Years of Age 60 Years of Age
CareStartTM COVID-19 Antigen
Total #
Positive
Prevalence
0
0
0.00%
22
3
13.64%
134
27
20.15%
24
2
8.33%
Positive results broken down by days since symptom onset:
Days Since Symptom Onset
1 2 3 4
5
CumuPlaots(iv+ite)ivReT-PCR CuCmOuVlPaIDotis-v1iet9ivCAeanr(e+tiS)gteanrtTM
0
0
7
7
15
15
23
22
32
30
PPA
100.00% 100.00% 95.65% 93.75%
95% Confidence interval
64.57% 79.62% 79.01% 79.85%
100.00% 100.00% 99.23% 98.27%
Clinical Performance Anterior Nasal Swab
The clinical performance characteristics of the CareStartTM COVID-19 Antigen
test using anterior nasal swab specimen were evaluated in a multi-site
prospective study in the U.S. between November 2020 and December 2020 against
an FDA Emergency Use Authorized RT-PCR
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,hoVprmIoaDutp-
ig1eah9rnaotltsiuoktehratmshdyeemttoUhpot.bSode.m.pApsartraeotnsitcedainplmotaiftneetgehdtraeiintnectt(hluh3es)eiPopsonatiur
/ntedti-xcyoci.pflTu-aoCstaiiobnrneeg criteria. All patients presented with
fever or at least two symptoms of COVID-19 infection. The patients presenting
the COVID-19 like symptoms within five (5) days of symptom onset at the study
sites were enrolled. Clinical studies in asymptomatic patients undergoing
serial testing are ongoing to establish the clinical performance. Two (2)
nasal swabs were collected using the provided swabs. One (1) swab was tested
on the CareStartTM COVID-19 Antigen test and the second swab was processed in
transport media for the comparator method. Collection order for the swab to be
tested on the CareStartTM COVID-19 Antigen test and the swab for reference
testing was randomized. Testing was performed by eight (8) operators with no
laboratory experience and who were representative of the intended users.
Operators were only using the QRI for the test without any training provided.
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)IlDlew-c1et9eredAfncrtooigmnesniidnetderivestiddcuoeamvl
sapyluamraepbdtleot.moTathhtieec comparator method is presented in the tables
below.
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CareStartTM COVID-19 Antigen
Positive
Comparator Negative
Total
Positive
34
0
34
Negative
5b
53
58
Total
39
53
92
Positive Percent Agreement (PPA)
87.18% (34/39) (95% CI: 73.29%-94.40%)
Negative Percent Agreement (NPA)
100.00% (53/53) (95% CI: 93.24%-100.00%)
bCOVID-19 was not detected in 0/5 False Negative specimens using an
alternative FDA-EUA molecular Assay
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Patient Demographics
Age Group
5 Years of Age 6-21 Years of Age 22-59 Years of Age 60 Years of Age
CareStartTM COVID-19 Antigen
Total #
Positive
Prevalence
1
1
100.00%
38
13
34.21%
47
20
42.55%
6
0
0%
Positive results broken down by days since symptom onset:
Days Since Symptom Onset
0
1 2 3 4
5
CumuPlaots(iv+ite)ivReT-PCR CuCmOuVlPaIDotis-v1iet9ivCAeanr(e+tiS)gteanrtTM
3
3
11
10
24
21
33
29
37
32
39
34
PPA
100% 90.91% 87.50% 87.88% 86.49% 87.18%
95% Confidence interval
43.85% 62.27% 69.00% 72.68% 72.02% 73.30%
100.01% 98.38% 95.66% 95.19% 94.09% 94.40%
Analytical Sensitivity: Limit of Detection (LoD)
The LoD for direct swab was established using heat-inactivated SARS-CoV-2
isolate USA-WA1/2020 (NR-52286). The strain was spiked into the pooled human
nasal swab matrix obtained from multiple healthy volunteers eluted in VTM and
confirmed as SARS-CoV-2 negative by RT-PCR to prepare positive samples. The
estimated LoD found from the initial two-fold serial dilution test was
confirmed by testing 20 replicates. The confirmed LoD for direct swab was 8 x
102 TCID50/ml.
AMnicarloytbiciaallISnpteercfiefirceitnyc:eCross Reactivity (Exclusivity) and
The potential cross-reactivity (exclusivity) of a panel of common organisms
was evaluated with SARS-CoV-2 negative samples using the CareStartTM COVID-19
Antigen test. Potential microbial interference was evaluated with samples
containing heat-inactivated SARS-CoV-2 isolate USA-WA1/2020 at approximately
3x LoD. A total of 8 bacteria were tested at a target concentration of
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105.2and 107.9 TCID50/ml. All negative samples gave negative results at the
concentrations of the potentially cross-reactive common organisms tested
showing no cross-reactivity with CareStartTM COVID-19 Antigen assay. All
samples with SARS-CoV-2 strain tested positive showing no microbial
interference at the concentrations of the potentially interfering common
organisms tested.
Potential Cross-Reactant
Adenovirus 1
MERS-Coronavirus, Irradiated Lysate
Bodetella pertussis
Adenovirus 7
Parainfluenza virus type 1
Candida albicans
Enterovirus 71, Tainan/4643/1998
Parainfluenza virus type 2
Chlamydophila pneumoniae
Human coronavirus(OC43)
Parainfluenza virus type 3
Haemophilus influenzae
Human coronavirus(229E)
Parainfluenza virus type 4
Legionella pneumophila
Human coronavirus(NL63) Respiratory syncytial virus Type B Mycoplasma pneumoniae
Human metapneumovirus(hMPV)
Rhinovirus
Staphylococcus aureus
Influenza A/Michigan/45/2015
SARS-Coronavirus
Staphylococcus epidermidis
Influenza B/Wisconsin/01/2010 Pooled human nasal wash
Streptococcus pneumoniae
Streptococcus pyogenes, Group A
To estimate the likelihood of cross-reactivity with SARS-CoV-2 of organisms that were not available for wet testing, in silico analysis using the Basic Local Alignment Search Tool (BLAST) managed by the National Center for Biotechnology Information (NCBI) was used to assess the degree of protein sequence homology. https://blast.ncbi.nlm.nih.gov/Blast.cgi?PAGE=Proteins&PROGRAM=blastp &BLAST_PROGRAMS=blastp&PAGE_TYPE=BlastSearch&BLAST_SPEC=blast 2seq&DATABASE=n/a&QUERY=&SUBJECTS=
The homology between SARS-CoV-2 nucleocapsid protein and human coronavirus
HKU1 nucleocapsid protein is relatively low, at 36.7% across 86.4% of
sequences, but cross-reactivity cannot be ruled out. The homology between
SARS-CoV-2 nucleocapsid protein and Mycobacterium tuberculosis total protein
(3,991 proteins) is relatively low, homology-based cross-reactivity can be
ruled out. The homology between SARS-CoV-2 nucleocapsid protein and
Pneumocystis jirovecii total protein (3,745 proteins) is relatively low,
homology-based cross-reactivity can be ruled out. The homology between SARS-
CoV-2 nucleocapsid protein and human coronavirus 229E nucleocapsid protein is
relatively low, at 28.8% across 72.1% of sequences, but cross-reactivity
cannot be ruled out. However, a result of the cross-reactivity wet study
showed that CareStartTM COVID-19 Antigen had no cross-reactivity against human
coronavirus 229E. No homologous protein was detected as a result of in silico
assay with all the proteins (686 proteins) of Mycoplasma pneumoniae and the
nucleocapsid protein (NP) of SARS-CoV-2.
Endogenous Interfering Substances Effect
To assess substances with the potential to interfere with the performance of
the CareStartTM COVID-19 Antigen, positive and negative samples were tested
with the addition of potentially interfering substances. The SARS-CoV-2 target
concentration in the positive samples was approximately 2x LoD. All samples
tested produced expected results, demonstrating that the CareStartTM COVID-19
Antigen test performance was not affected by any of the 30 potentially
interfering substances listed in the table below at the concentrations tested.
Potential Interfering Substances
Acetaminophen Acetyl salicylic acid Beclomethasone
Benzocaine Budesonide Chlorpheniramine maleate Dexamethasone Dextromethorphan
HBr Diphenhydramine HCl Ephedrine HCl Flunisolide Fluticasone Guaiacol
Glyceryl Ether Histamine Dihydrochloride
Menthol
Concentration
10 mg/ml 15 mg/ml 0.5 mg/ml 5 mg/ml 2 mg/ml 5 mg/ml 1 mg/ml 2 mg/ml 5 mg/ml 10
mg/ml 5 mg/ml 1 mg/ml 20 mg/ml 10 mg/ml 10 mg/ml
Potential Interfering Substances
Mometasone Mucin
Mupirocin OTC Throat drop (Halls) OTC Throat drop (Ricola) OTC Nasal spray
(Afrin) OTC Nasal spray (VicksSinex) OTC Nasal spray (Zicam)
Oxymetazoline HCl Phenylephrine HCl Phenylpropanolamine
Tobramycin Triamcinolone Whole Blood
Zanamivir
Concentration
1 mg/ml 2%
1 mg/ml 15% 15% 15% 15% 15%
10 mg/ml 5 mg/ml 5 mg/ml 1 mg/ml 1 mg/ml
4% 1 mg/ml
The interfering effects of biotin concentrations ranging between 625 ng/mL and
10 µg/mL were tested in a separate study. Biotin concentrations up to 1.25
µg/ml did not lead to false results. Biotin concentrations 2.5 µg/ml can cause
false-negative COVID-19 results with the CareStartTM COVID-19 Antigen.
High-dose Hook Effect
The CareStartTM COVID-19 Antigen was tested up to 105 TCID50 /ml of heat-
inactivated SARS-CoV-2 strain and no high-dose hook effect was observed.
Point of Care Use
The CareStartTM COVID-19 Antigen was demonstrated at near patient or Point of
Care (POC) testing that non-laboratory personnel can perform the test
accurately in the intended use environment. In addition, the robust use of the
CareStartTM COVID-19 Antigen for near patient or Point of Care (POC) testing
was demonstrated by thirteen (13) Flex studies.
Technical Support
For questions, or to report a problem, please call Technical Support at
+1-888-898-1270 (Available Hours: Mon.
to Fri.: 8 a.m. 5 p.m.) or TShelp@accessbio.net (24/7 available).
Test system problems may also be reported to the FDA using the MedWatch
reporting system (phone: 1-800 FDA-1088; fax: 1-800 FDA-1078: or
http://www.fda.gov/medwatch).
QRI-RCHM-E / Rev. C / Apr. 15, 2021
References
- Access Bio – A TRUSTED PARTNER IN GLOBAL HEALTH
- HHS Accessibility & Section 508 | HHS.gov
- Access Bio – A TRUSTED PARTNER IN GLOBAL HEALTH
- MedWatch: The FDA Safety Information and Adverse Event Reporting Program | FDA
- Intrivo | Get Back to What Matters
- Protein BLAST: search protein databases using a protein query