of 5
Open Forum Infectious Diseases
BRIEF REPORT
Laboratory Evaluation Links Some
False-Positive COVID-19 Antigen Test
Results Observed in a Field Study to a
Specific Lot of Test Strips
Alyssa M. Carter,
a,
Alexander Viloria Winnett,
a,
Anna E. Romano,
Reid Akana,
Natasha Shelby,
and Rustem F. Ismagilov
Chemistry and Chemical Engineering, California Institute of Technology, Pasadena, California,
USA
During a household-transmission field study using COVID-19
antigen rapid diagnostic tests (Ag-RDT), a common test strip
lot was identified among 3 participants with false-positive
results. In blinded laboratory evaluation, this lot exhibited a
significantly higher false-positive rate than other lots.
Because a positive Ag-RDT result often prompts action,
reducing lot-specific false positives can maintain confidence
and actionability of true-positive Ag-RDT results.
Keywords.
COVID-19; diagnostics; false positive; faulty
lot; lateral flow test; Quidel QuickVue.
Received 03 November 2022; editorial decision 23 December 2022; accepted 03 January
2023; published online 5 January 2023
a
A. M. C. and A. V. W. contributed equally to this work.
Correspondence: Rustem F. Ismagilov, PhD, Chemistry & Chemical Engineering, California
Institute of Technology, 1200 E California Blvd, Pasadena, CA 91125 (rustem.admin@caltech.
edu).
Open Forum Infectious Diseases
®
© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases
Society of America. This is an Open Access article distributed under the terms of the
Creative Commons Attribution-NonCommercial-NoDerivs licence (https://creativecommons.
org/licenses/by-nc-nd/4.0/
), which permits non-commercial reproduction and distribution of
the work, in any medium, provided the original work is not altered or transformed in any
way, and that the work is properly cited. For commercial re-use, please contact journals.permis
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sions@oup.com
https://doi.org/10.1093/ofid/ofac701
Antigen rapid diagnostic tests (Ag-RDTs) are increasingly used
for detection of severe acute respiratory syndrome coronavirus
2 (SARS-CoV-2). Usage of at-home Ag-RDTs in the United
States (US) has increased nearly 4-fold among those with self-
reported coronavirus disease 2019 (COVID-19)–like illness
between the period of Delta (23 August–11 December 2021)
to Omicron (19 December 2021–12 March 2022) variant pre
-
dominance [
1]. Ag-RDTs are also used widely for test-to-enter
events and serial screening testing in schools and workplaces;
for example, in May 2022 [2], the California Department of
Public Health began recommending Ag-RDTs as the primary
test for COVID-19 in schools [3].
Ag-RDTs typically have very high specificity; of the 51
Ag-RDTs currently authorized for at-home use in the US as
of 2 September 2022, all are required to demonstrate false-
positive rates of
2% [4
]. However, with widespread use
imperfect specificity can result in many false-positive results,
and at low prevalence of infection, these false positives can
represent a large fraction of or even dominate among all posi
-
tive results [
5].
As part of a COVID-19 household-transmission field study
in Southern California initiated in November 2021, partici
-
pants performed a daily at-home nasal swab Ag-RDT (Quidel
QuickVue At-Home OTC COVID-19 Test) and self-collected
saliva, anterior nares swab, and oropharyngeal swabs for
reverse-transcription quantitative polymerase chain reaction
(RT-qPCR) testing [
6]. This test was selected for the field study
because it was one of the first Ag-RDTs to be granted US Food
and Drug Administration Emergency Use Authorization [7]
and is widely in use in the US and internationally.
In January 2022, interim analysis of the field study showed a
string of 24 Ag-RDT positive results from participants who had
corresponding negative results in all 3 specimen types tested
by RT-qPCR, causing an elevated clinical false-positive
rate (Figure 1
A
). Further investigation revealed a common
Ag-RDT strip lot number (152000) among 3 participants
with false-positive results. We then investigated the technical
false-positive rate of Ag-RDT test strip lot 152000, and other
lots acquired for use in the field study, in a controlled laborato
-
ry setting.
METHODS
Participant Consent Statement
The Ag-RDT field study [6
] was approved by the California
Institute of Technology Institutional Review Board under pro
-
tocol number 20-1026. All adult participants in the study pro
-
vided written informed consent and all minors provided verbal
assent accompanied by written parental permission.
Laboratory Evaluation of Ag-RDT Test Strips
We created contrived specimens using heat-inactivated
SARS-CoV-2 particles (BEI, catalog number NR-52286, lot
70034991) spiked into commercial SARS-CoV-2–negative hu
-
man nasal fluid (Lee BioSolutions, catalog number 991-13-P,
lot 03f4044 and catalog number 991-13-P-PreC, lot 09F3280)
at concentrations above and below the inferred limit of detec
-
tion (LOD) for this assay (7
×
10
6
copies/mL) [
6
] and applied
them to 2 lots of test strips (152194 and 152532) that did not
yield any false-positive results among participants in the field
study. Contrived specimens with SARS-CoV-2–negative hu
-
man nasal fluid alone were also applied to 4 Ag-RDT strip
lots (152194, 152532, 000202, as well as 152000, the lot com
-
mon to participants with observed clinical false-positive
BRIEF REPORT •
OFID
• 1
results).
The order
of contrived
specimens
and Ag-RDT
strip
lots was randomized
by the operator.
Contrived
specimens
(20 μL) were pipetted
onto the swab
that came
with each Ag-RDT,
and the swab was placed
into
the Ag-RDT
tube containing
buffer.
Manufacturer
instructions
were then followed
exactly
[
8
], by mixing
the swab in the buffer
for 1 minute,
removing
the swab, then placing
an Ag-RDT
strip
in the tube and incubating
at room temperature
for 10 minutes.
The result
was then interpreted
within
5 minutes
by 3 readers
blinded
to the experimental
conditions
and test strip lot num
-
bers; each trial with a single
test strip therefore
resulted
in 3 in
-
dependent
reads.
Readers
were provided
with the manufacturer
instructions
for result
interpretation
[
8
] and no additional
guidance.
Readers
were unable
to see the interpretations
of
other readers.
Statistical
Methods
Clinical
false-positive
results
were defined
as positive
Ag-RDT
results
reported
by a study
participant,
at the same timepoint
when
saliva,
nasal swab,
and oropharyngeal
swab specimens
collected
by the same participant
all resulted
negative
by high-
analytical
RT-qPCR
testing.
The clinical
false-positive
rate was
calculated
as the number
of clinical
false-positive
Ag-RDT
re
-
sults over all timepoints
with false-positive
and true-negative
Ag-RDT
results,
using
RT-qPCR
as the reference
standard.
The clinical
false-positive
rate was binned
by 2-week
periods
for visualization
(
Figure
1
A
).
Technical
false-positive
Ag-RDT
results
were defined
as
reads interpreted
as positive
when contrived
specimen
contain
-
ing only SARS-CoV-2–negative
nasal
fluid was tested.
The
technical
false-positive
rate was calculated
as the number
of
technical
false-positive
reads
over all reads
originating
from
specimen
containing
only SARS-CoV-2–negative
nasal fluid.
The technical
false-positive
rate was grouped
by Ag-RDT
strip
lot (
Figure
1
B
).
The 95% confidence
interval
(CI) of both the clinical
and
technical
false-positive
rate was calculated
using
the method
described
in the Clinical
and Laboratory
Standards
Institute
EP12-A2
document
[
9
]. Statistical
testing
was performed
to as
-
sess differences
in the clinical
false-positive
rates between
time
periods
in the field study (
Figure
1
A
), and to compare
the tech
-
nical false-positive
rates between
Ag-RDT
strip lots in the lab
-
oratory
evaluation
(
Figure
1
B
); for all analyses
we used the
Fisher
exact test, implemented
in Python
3.8.8.
RESULTS
A significantly
elevated
clinical
false-positive
rate was observed
among
participants
in a field study
of a COVID-19
Ag-RDT,
compared
with what had previously
been observed
in the study
(
P
<
.01, upper-tailed
Fisher
exact test;
Figure
1
A
). The elevated
false-positive
rate prompted
the identification
of a common
Ag-RDT
strip lot (152000)
among
3 participants
with multiple,
daily clinical
false-positive
results.
We then sought
to evaluate
the technical
false-positive
rate of this lot and other
lots ac
-
quired
for use in the field study,
through
laboratory
evaluation.
To confirm
that this Ag-RDT
could
be performed
and pro
-
duce expected
results
in a laboratory
setting,
we created
con
-
trived
specimens
with and without
SARS-CoV-2
particles.
Contrived
specimens
were applied
to 2 Ag-RDT
strip lots
that had not yielded
clinical
false-positive
results
in the field
study.
Positive
reads
were expected
when
nasal
fluid with
viral concentrations
above
the LOD were applied
to Ag-RDT
strips,
and negative
reads
were expected
when
viral concen
-
trations
were
below
the inferred
LOD,
and when
only
Figure
1.
Clinical
false-positive
rate of antigen
rapid diagnostic
tests (Ag-RDTs)
among
participants
in a coronavirus
disease
2019
(COVID-19)
household-
transmission
field study and subsequent
laboratory
evaluation
of technical
false-
positive
rates among
Ag-RDT
strip lots.
A
, The biweekly
clinical
false-positive
r
-
ate for nasal swab Ag-RDT,
defined
as a positive
Ag-RDT
at the same timepoint
as negative
results
by reverse-transcription
quantitative
polymerase
chain reaction
(RT-qPCR)
in saliva,
nasal swabs,
and oropharyngeal
swab specimens.
The propor
-
tions displayed
below
each month
represent
the number
of clinical
false-positive
results
over the total number
of false-positive
and true-negative
Ag-RDT
results
in the field study during
each period.
Error bars represent
95% confidence
interval
(CI).
B
, Laboratory
evaluation
of the technical
false-positive
rate for 4 Ag-RDT
strip
lots was performed
using severe
acute respiratory
syndrome
coronavirus
2 (SARS-
CoV-2)–negative
human
nasal fluid (see Methods).
The proportion
of technical
false-positive
reads to all reads by readers
blinded
to experimental
conditions
is
displayed
below
each lot number.
P
values
were obtained
using an upper-tailed
Fisher
exact test. Additional
details
are provided
in
Supplementary
Table 1
.
2 •
OFID
• BRIEF
REPORT
SARS-CoV-2–negative
nasal fluid (without
any viral particles)
was applied.
Contrived
specimens
with SARS-CoV-2
concen
-
trations
between
1.0
×
10
7
and 1.5
×
10
7
copies/mL
(above
the
inferred
LOD of the Ag-RDT)
were interpreted
by readers
as
positive
in 8 of 9 reads
(3 independent
trials
each with 3
reads,
1 from
each reader);
contrived
specimens
with viral
concentrations
between
2.0
×
10
6
and 4.1
×
10
6
copies/mL
(be
-
low the inferred
LOD of the Ag-RDT)
were interpreted
by
readers
as negative
in all 6 reads
(
Supplementary
Table
1
).
These
results
confirmed
that the Ag-RDT
used in the field
study
yields
expected
positive
and negative
results
with con
-
trived
specimens
in a laboratory
setting.
To assess
the technical
false-positive
rate of different
lots,
SARS-CoV-2–negative
human
nasal fluid (without
the addi
-
tion of viral particles)
was applied
to Ag-RDT
strips
from 4
lots: 152194,
152532,
000202,
and 152000
(the lot that produced
clinical
false
positives
among
3 different
participants)
(
Figure
1
B
). No false-positive
reads were reported
for any trial
performed
on lots 152194,
152532,
or 000202.
However,
14 of
18 reads from lot 152000
were interpreted
by readers
as posi
-
tive, yielding
a technical
false-positive
rate of 77% (95% CI,
55%–91%);
1 read from this lot was interpreted
as invalid.
Furthermore,
at least 1 reader
interpreted
a positive
result
for
every
trial with
a lot 152000
test strip
(
Supplementary
Table
1
). The false-positive
rate of Ag-RDT
strip lot 152000
on laboratory
evaluation
was significantly
higher
than the
false-positive
rate observed
for the other 3 test strip lots ana
-
lyzed (
P
<
.01, upper-tailed
Fisher
exact test).
DISCUSSION
In a field study of a COVID-19
Ag-RDT
in Southern
California,
a specific
lot of test strips
was found
to be common
among
3 participants
(from
3 different
households)
with false-positive
Ag-RDT
results.
These
participants
had negative
test results
in
3 paired
high-analytical-sensitivity
RT-qPCR
assays
(saliva,
na
-
sal swab,
and oropharyngeal
swab)
that were collected
at the
same timepoint.
Laboratory
evaluation
confirmed
that when
SARS-CoV-2–negative
nasal fluid was tested
with this specific
lot of Ag-RDT
strips,
readers
blinded
to randomized
test con
-
ditions
and strip lot numbers
consistently
interpreted
results
as positive.
The laboratory
evaluation
supports
that this lot
was likely yielding
false-positive
results
when in use by partic
-
ipants
in our field study.
At-home
Ag-RDTs
are known
to have low clinical
sensitivity
[
6
,
10
,
11
] and are likely to produce
false-negative
results.
The
low clinical
sensitivity
of Ag-RDTs
is due to both their low-
analytical
sensitivity
(high limits
of detection)
and, in the US,
their authorized
use exclusively
with nasal
swab specimens,
which
are not always
representative
of the patient
infection
sta
-
tus, especially
early in the infection
[
6
,
12–16
]. The Centers
for
Disease
Control
and Prevention
(CDC)
has recognized
the lack
of clinical
sensitivity
of Ag-RDTs
and in September
2022 up
-
dated recommendations
to Ag-RDT
testing
protocols
to repeat
testing
24–48
hours
later [
17
].
False positives
are less frequent.
The manufacturer
of the
Quidel
QuickVue
At-Home
OTC
COVID-19
Test,
which
was not involved
in the design
or execution
of this study,
re
-
ports
a 99.2 negative
percent
agreement
[
8
], and Ag-RDTs
generally
have
>
97%
clinical
specificity
in field evaluations
[
11
,
18
]. By late 2020, the CDC recommended
a confirmatory
nucleic
acid amplification
test for Ag-RDT–positive
results
in cases
with low pretest
probability
[
19
]. However
as of
April 2022, a single
positive
result
now typically
prompts
im
-
mediate
action
from
individuals,
their close
contacts,
and
healthcare
personnel
[
20
]. Notably,
the Emergency
Use
Authorization
for the Quidel
QuickVue
At-Home
OTC
COVID-19
Test [
21
] encourages
individuals
who test positive
to self-isolate
and contact
their healthcare
provider
for follow-
up care, which
may include
additional
testing.
Therefore,
false-positive
results
can prompt
unnecessary
isolation
and
quarantine,
needless
treatment,
consumption
of additional
testing
resources,
and diversion
of contact
tracing
efforts
from true-positive
cases
[
22
]. Further,
false-positive
results
undermine
trust in positive
Ag-RDT
results,
such that isola
-
tion, treatment,
additional
testing,
and contact
tracing
may
not be initiated
when
it is appropriate.
False-positive
Ag-RDT
results
are not unique
to the current
COVID-19
pandemic.
The Quidel
QuickVue
Influenza
A+B
Test, another
Ag-RDT
that uses nasal swab specimens,
is re
-
ported
by the manufacturer
to have
>
97 negative
percent
agreement
[
23
], but during
the 2009 influenza
A(H1N1)
pan
-
demic,
the clinical
performance
of the test resulted
in a 62.2
negative
percent
agreement
against
RT-PCR
[
24
].
COVID-19
Ag-RDT
false-positive
results
have been report
-
ed in a number
of contexts
[
18
,
25
,
26
]. In a recent
evaluation
of
the Quidel
QuickVue
At-Home
OTC COVID-19
test in a col
-
lege community
[
27
], 8 of 11 participants
with positive
Ag-RDT
results
were found
to be negative
on RT-PCR
testing
within
24 hours.
No definitive
cause for these false-positive
re
-
sults was identified.
False-positive
results
may occur
due to a variety
of reasons
[
22
,
25
,
28–30
], including
user error,
invalid
test conditions,
improper
storage
or manufacturing
errors
that affect
reagent
chemistry,
or off-target
binding
of human
or microbial
materi
-
al (including
viruses
other than SARS-CoV-2);
for example,
in
-
fection
of human
rhinovirus
A has produced
false-positive
results
in SARS-CoV-2
Ag-RDTs
[
26
]. However,
both we
and others
[
31
,
32
] have found
false-positive
Ag-RDT
results
traceable
to specific
lots. Importantly,
the overall
false-positive
rate observed
among
participants
in our field study
was 2.8%
(95%
CI, 2.1%–3.9%)
[
6
]; monitoring
only an overall
false-
positive
rate across
lots could
mask
specific
lots with higher
false-positive
rates.
BRIEF
REPORT
OFID
• 3
Lot issues
can arise during
manufacturing
and transporta
-
tion or can be due to storage
conditions
after distribution
[
33
,
34
]. In our study,
Ag-RDTs
were stored
at room tempera
-
ture and the mild winter
climate
in Southern
California
en
-
sured
that temperatures
were stable
during
shipment
as well.
Here,
we demonstrate
through
a controlled
laboratory
evalua
-
tion that false-positive
results
captured
in a field study
of
Ag-RDTs
were not due to operator
error but were lot specific.
Therefore,
efforts
to monitor
for lot-dependent
false positives
(and whether
they originate
from issues
at the manufacturer
or distributor/retailer
level) can increase
the confidence
and ac
-
tionability
of positive
Ag-RDT
results.
Supplementary
Data
Supplementary
materials
are available
at
Open
Forum
Infectious
Diseases
online.
Consisting
of data provided
by the authors
to benefit
the reader,
the
posted
materials
are not copyedited
and are the sole responsibility
of the
authors,
so questions
or comments
should
be addressed
to the correspond
-
ing author.
Notes
Acknowledgments.
We thank
the study
participants
for making
this
work possible.
We thank
Study
Coordinators
Saharai
Caldera
for suggest
-
ing the laboratory
evaluation
and both Saharai
and Hannah
Davich
for re
-
moving
lot 152000
from
circulation
in the study.
We thank
Taikun
Yamada,
John Raymond
B. Reyna,
Paolo
Piatti,
and Yap Ching
Chew
for
performing
and verifying
the validity
of RT-qPCR
results
as previously
re
-
ported.
Finally,
we thank
all the case investigators
and contact
tracers
at the
Pasadena
Public
Health
Department
and Caltech
Student
Wellness
Services
for their efforts
in study
recruitment
and their work
in the pandemic
response.
Data
availability.
The data underlying
the results
presented
in the study
are available
at CaltechDATA
at:
https:/
/doi.org/10.22002/fmz6a-0x036
.
Financial
support.
This work was supported
by the Ronald
and Maxine
Linde
Center
for New Initiatives
at the California
Institute
of Technology
and the Jacobs
Institute
for Molecular
Engineering
for Medicine
at the
California
Institute
of Technology.
A. V. W. is supported
by a Geffen
Fellowship
at the David
Geffen
School
of Medicine,
University
of
California,
Los Angeles.
Potential
conflicts
of interest
.
R. F. I. is a co-founder,
consultant,
and di
-
rector
for and has stock ownership
in Talis Biomedical
Corporation.
All
other authors
report
no potential
conflicts.
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