Southern California Permanente- Kaiser Permanente High Throughput SARS-CoV-
2 Assay EUA Summary – Updated September 22, 2021
EMERGENCY USE AUTHORIZATION (EUA) SUMMARY
For the Kaiser Permanente High Throughput SARS-CoV-2 Assay
For in vitro Diagnostic Use
Rx Only
For 18 years of age or older
For Use Under Emergency Use Authorization (EUA) Only
The Kaiser Permanente High Throughput SARS-CoV-2 Assay will be used with the
Kaiser Permanente Saliva Home Collection Kit. Testing will be performed at the SCPMG-
RRL located at 13000 Peyton Drive, Chino Hills, CA 91709 which is certified under
Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and
meets requirements to perform high complexity tests, as described in the Laboratory
Standard Operating Procedure that was reviewed by the FDA under this EUA.
INTENDED USE
The Kaiser Permanente High Throughput SARS-CoV-2 Assay is a real-time reverse transcription
polymerase chain reaction (RT-PCR) test intended for qualitative detection of nucleic acid from
SARS-CoV-2 in saliva that is self-collected unsupervised at home using the Kaiser Permanente
Saliva Home Collection Kit, by individuals 18 years or older suspected of COVID-19, when
determined to be appropriate by a healthcare provider. Specimens collected using the Kaiser
Permanente Saliva Home Collection Kit can be transported at ambient temperature for testing.
Testing is limited to the Southern California Permanente Medical Group - Regional Reference
Laboratory (SCPMG-RRL) located at 13000 Peyton Drive, Chino Hills, CA 91709 which is
certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a,
and meets requirements to perform high complexity tests.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally
detectable in saliva during the acute phase of infection. Positive results are indicative of the
presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic
information is necessary to determine patient infection status. Positive results do not rule out
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 do not preclude SARS-CoV-2 infection and should not be used as the sole basis
for patient management decisions. Negative results must be combined with clinical observations,
patient history, and epidemiological information. Negative results for SARS-CoV-2 RNA from
saliva should be confirmed by testing of an alternative specimen type if clinically indicated.
The Kaiser Permanente High Throughput SARS-CoV-2 Assay is intended for use by qualified
laboratory personnel specifically instructed and trained in molecular testing and in vitro
diagnostic procedures. The Kaiser Permanente High Throughput SARS-CoV-2 Assay and the
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Kaiser Permanente Saliva Home Collection Kit are only for use under the Food and Drug
Administration’s Emergency Use Authorization.
DEVICE DESCRIPTION AND TEST PRINCIPLE
1) Device Description
The Kaiser Permanente High Throughput SARS-CoV-2 Assay is a real-time reverse transcription
polymerase chain reaction (RT-PCR) test intended for the qualitative detection of nucleic acid
from SARS-CoV-2 performed on the Thermo Fisher Amplitude Solutions System. The SARS-
CoV-2 primers are designed to detect RNA from SARS-CoV-2 in saliva specimens from
individuals 18 years old or older as recommended for testing by a healthcare provider.
Saliva specimens must be self-collected using the Kaiser Permanente Saliva Home Collection
Kit which contains the Spectrum Solutions, LLC SDNA-1000 Saliva Collection Device.
Kaiser Permanente Saliva Home Collection Kit Ordering Process:
Individuals may request the Kaiser Permanente Saliva Home Collection Kit by either speaking
with a healthcare provider or requesting a test through an online questionnaire. The questionnaire
is reviewed by a physician to ascertain patient symptoms or reasons for testing, such as exposure
to COVID-19 and criteria that follows the CDC recommendations for testing prioritization.
Patients are then approved by the healthcare provider to receive the unobserved self-collect Kaiser
Permanente Saliva Home Collection Kit for at home collection. The home collection kit is only
distributed to the patient after a prescription is written for the test.
The Kaiser Permanente Saliva Home Collection Kit collects and stabilizes viral RNA from saliva
specimens and can also be used for the transportation and storage of samples. The Kaiser
Permanente Saliva Home Collection Kit is for saliva self-collection from individuals who are
suspected of COVID-19 by their healthcare provider for use with The Kaiser Permanente High
Throughput SARS-CoV-2 Assay.
The Kaiser Permanente Saliva Home Collection Kit consists of the Spectrum Solutions, LLC
SDNA-1000 Saliva Collection Device, an outbound corrugated box, biohazard specimen bag with
absorbent material, pre-labeled return shipping bag along with a digitally printed personalized
letter containing the sample identification label and instructions for shipping the samples. Saliva
specimens must be received in the laboratory within 96 hours of sample collection. Specimens
are received at the clinical laboratory for testing with the Kaiser Permanente High Throughput
SARS-CoV-2 Assay.
Test results are returned to the individual who use the Kaiser Permanente Saliva Home Collection
Kit via a secure online portal. Kaiser Permanente Medical Center staff will verbally contact patients
who receive a positive or invalid/inconclusive result for follow up.
2) Test Principle
The Kaiser Permanente High Throughput SARS-CoV-2 Assay uses the TaqPath COVID-19
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High Throughout Combo Kit which contains primers to detect specific nucleic acid sequences
from the genome of the SARS-CoV-2 virus from the nucleocapsid (N) gene, spike glycoprotein
gene (S), and ORF1ab region. The bacteriophage MS2 is also a target in the test to serve as an
internal and extraction control.
The Kaiser Permanente High Throughput SARS-CoV-2 Assay is performed using the fully
automated Thermo Fisher Amplitude Solutions System.
The real‑time RT‑PCR data is automatically analyzed by the Amplitude System COVID‑19
Interpretive Software Driver to determine the presence or absence of SARS-CoV-2 RNA. A
summary of the Kaiser Permanente High Throughput SARS-CoV-2 Assay workflow is illustrated
in Figure 1.
Figure 1. Kaiser Permanente High Throughput SARS-CoV-2 Assay Workflow
COLLECTION KITS USED WITH THE TEST
This test must be used with the Kaiser Permanente Saliva Home Collection Kit to self-collect saliva
specimens at home when determined to be appropriate by an HCP.
REAGENTS AND MATERIALS
Table 1 below lists the kit components for use with the Kaiser Permanente High Throughput
SARS-CoV-2 Assay.
20 minutes
•Prepare sample tube run
•A Module 1 technician loads up to 376 sample tubes into the Tecan
sample tube runners
1 hour
•Perform a Module 1 run
•During a Module 1 run, the Tecan Fluent 1080 Automation
Workstation transfers samples and reagents for RNA extraction to
four deep-well plates.
2 hours and
15 minutes
•Perform a Module 2 run
•Performs RNA extraction and real-time RT-PCR. The results are
analyzed and sent to the SampleManager LIMS Software for review
15 minutes
•Review results (automated workflow)
•Analyzed real-time RT-PCR results are automatically transferred to the
SampleManager LIMS Software for review, authorization, and archival.
Once authorized, results are exported as a CSV file.
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Table 1. Reagents for Use with the Kaiser Permanente High Throughput SARS-CoV-2 Assay
Components
Amount
Cat. No.
Sub-kits
TaqPath COVID‑19
High‑Throughput Combo
Kit
20,000
reactions
A49869
TaqPath COVID-19 Module 1 MS2
Phage Control × 3
TaqPath COVID-19 Module 2 assay Kit
× 3
TaqPath COVID-19 Control × 3
TaqPath COVID-19 Module 2 Control
Dilution Buffer × 3
TaqPath HT Module 2 Empty Mixing
Tubes × 3
Amplitude
High‑Throughput
Consumable Package 1
Reagent Kit
20,000
reactions
A49599
MagMAX MVPII HT Module 1
Sample Prep Kit × 3
MagMAX MVPII HT Module 2
Sample Prep Kit × 3
TaqPath HT Module 2 1-Step
Multiplex Master Mix (No ROX) × 3
Amplitude
High‑Throughput
Consumable Package
3 Plastics
40,000
reactions
A49663
Amplitude
Plastics and Tips Combo Kit 1
Amplitude Plastics Combo Kit 2
Nunc Microplate Lids
ASSAY CONTROLS
Assay controls listed in Table 2 are run concurrently with test samples in each run of the Kaiser
Permanente High Throughput SARS-CoV-2 Assay. The MS2 phage control is added to each
sample prior to extraction. The assay positive, MS2, and negative controls are provided ready to
use, no preparation is required.
Table 2. Assay Controls for the Kaiser Permanente High Throughput SARS-CoV-2 Assay
Used to monitor
Assays
RT-PCR reaction setup and reagent
integrity
All three SARS-CoV-2
assays
RNA extraction
MS2 assay
Cross-contamination during RNA
extraction and RT-PCR reaction setup
All three SARS-CoV-2
assays
MS2 assay
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INTERPRETATION OF RESULTS
All test controls must pass for the real-time RT-PCR plate results to be considered valid. Validation
of the results is performed automatically based on the performance of the positive and negative
controls. The Ct cutoff values for assay targets indicated in Table 3 are used during the
interpretation of results.
Table 3. Ct cutoff values for assay targets
Sample
Target C
t
cutoff
Result
Positive Control
MS2 – C
t
values are >37
Valid Positive Control
Viral targets – C
t
values are ≤37
Negative Control
MS2 – C
t
values are ≤32
Valid Negative Control
Viral targets – C
t
values are >37
Clinical samples
MS2 – C
t
values are ≤32
For interpretation of the
test results, see Table 4
Viral targets – Positive C
t
values are ≤37
The results for each assay target are used to determine the status and result for the sample, as
indicated in Table 4.
Table 4. Interpretation of test results
ORF1
ab
N
gene
S
gene
MS2
Status
Result
Action
NEG
NEG
NEG
NEG
INVALID
NA
Repeat test. If the repeat
result remains invalid,
consider collecting a
new specimen.
NEG
NEG
NEG
POS
VALID
SARS-CoV-2
Not Detected
Report results to a
healthcare provider.
Only one SARS-CoV-2
target = POS
POS
or
NEG
VALID
SARS-CoV-2
Inconclusive
Repeat test. If the repeat
result remains
inconclusive, additional
confirmation testing
should be conducted if
clinically indicated.
Two or more SARS-
CoV-2 targets = POS
POS
or
NEG
VALID
Positive
SARS-CoV-2
Report results to a
healthcare provider.
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SPECIMEN COLLECTION CONTROL
The integrity of the saliva specimen collected with the Kaiser Permanente Saliva Home Collection
kit is visually evaluated during the accessioning process in the laboratory prior to placing the
sample into the Amplitude system. The samples are inspected to confirm that the minimum volume
requirements have been met, as indicated by the fill line on the sample collection device. The
release of the stabilizing solution into the sample, consistency of the saliva sample, and presence
of mucus is also assessed to determine acceptability for testing. The assay includes an internal
MS2 Phage control that is added to each sample to monitor for the integrity of nucleic acid
extraction and RT-PCR.
COMPONENTS INCLUDED WITH THE COLLECTION KIT
The Kaiser Permanente Saliva Home Collection Kit includes the Spectrum Solutions, LLC
SDNA-1000 Saliva Collection Device to self-collect saliva specimens at home when
determined to be appropriate by an HCP. The components for the Kaiser Permanente Saliva
Home Collection Kit, described in Table 5, will be assembled and distributed by a fulfillment
vendor, Previon.
Table 5. Contents of the Kaiser Permanente Saliva Home Collection Kit
Name
Description
Quantity
Material Supplier
SDNA-1000 blister
pack
Saliva collection device,
sample collection
instructions
1
Spectrum Solutions,
LLC
Outbound
corrugated box
6 ¾” x 4 ½” x 2 ¼”
white
1
Premier: My Binding
Backup(s): Kelly
Paper, Veritek
Printed
personalized letter
with ID label and
shipping
instructions
Digitally printed
1
Premier: Best Forms
Backup: Wright
Business Graphics
Biohazard bag
Biohazard bag
1
Premier: Kelly Paper
Backup: Veritek
Shipping polybag,
prelabeled and pre-
paid
Opaque polybag for
shipping sample.
Includes SCPMG-RRL
return address
1
Premier: Best Forms
Backup: Wright
Business Graphics
In addition to the printed sample collection and shipping instructions provided in the Kaiser
Permanente Saliva Home Collection Kit, patients will also have access to an instructional video,
by scanning a QR code provided on the individualized letter in the collection kit. The
instructional video demonstrates how to fill the sample tube, seal the tube, label the sample, and
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package the sample for return shipping. The video can be viewed here:
https://kp.qumucloud.com/view/oPAP-COVID-Home-Saliva-Test-How
SAMPLE STABILITY
Spectrum Solutions, LLC has granted Southern California Permanente a Right of Reference
(RoR) to leverage the sample stability data for saliva samples collected in the SDNA-1000 to
support 7 day sample stability at room temperature (15⁰C-30⁰C) and the data supporting viral
inactivation of SARS-CoV-2 virus in the SDNA-1000 collection device.
SAMPLE SHIPPING STABILITY
Southern California Permanente performed a shipping stability study with simulated shipping
conditions that were designed to evaluate the impact variations of extreme temperatures on the
stability of SARS-CoV-2 RNA during transport of SDNA-1000 saliva specimens. This study
used residual clinical specimens, previously reported as SARS-CoV-2 negative using the Kaiser
Permanente High Throughput SARS-CoV-2 Assay with the Kaiser Permanente Saliva Home
Collection Kit spiked with inactivated SARS-CoV-2 viral material. The inactivated SARS-CoV-
2 was spiked into negative pooled clinical saliva matrix, within 24 hours of initial laboratory
receipt, to replicate a clinical specimen most closely. Testing included 25 spiked samples at 2x
LoD (low positives), 8 spiked samples at 5x LoD, 7 spiked samples at 10x LoD (high positives),
and 14 SARS-CoV-2 negative saliva samples. Samples were initially tested (Day 0) then
subjected to the summer and winter temperature cycles described in Tables 6 and 7 at 80 hours
and 112 hours post time Zero. All 14 negative SARS-CoV-2 samples remained negative for each
target when tested in both the winter and summer temperature excursions. Testing was performed
with the Kaiser Permanente High Throughput SARS-CoV-2 Assay according to the authorized
SOP. Results (Tables 8 and 9) were obtained and compared to those reported upon Day 0 testing.
The data provided supports 96 hours specimen shipping stability for specimens collected using
the Kaiser Permanente Saliva Home Collection Kit.
Table 6. Summer temperature cycles
Temperature
Cycle
Period
Cycle
Period
Hours
Total Time
Hours
40°C
1
8
8
22°C
2
4
12
40°C
3
6
18
30°C
4
56
74
40°C
5
6
80 ---->test
30°C
6
32
112 ---->test
Table 7. Winter temperature cycles
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Temperature
Cycle
Period
Cycle
Period
Hours
Total Time
Hours
-20°C
1
8
8
18°C
2
4
12
-20°C
3
6
18
10°C
4
56
74
-20°C
5
6
80 ---->test
10°C
6
32
112 ---->test
Table 8. Summary of Summer Profile Results
Sample
Gene
Detection
Day 0
Mean
Ct
Value
80
Hours
Mean
Ct
Value
80
Hours
Mean
Ct Diff.
112
hours
Mean
Ct
Value
112
Hours
Mean
Ct. Diff
Number
tested/
Concordant
Results
2x LoD
MS2
29.32
29.67
0.3
29.75
0.4
25/25
SARS-CoV-2
Positive
N gene
39.36
29.71
0.4
29.81
0.4
ORF1ab
29.37
29.71
0.3
29.83
0.5
S gene
29.37
29.74
0.4
29.86
0.5
5x LoD
MS2
28.25
28.34
0.1
28.50
0.2
8/8
SARS-CoV-2
Positive
N gene
28.36
28.44
0.1
28.64
0.3
ORF1ab
28.35
28.45
0.1
28.66
0.3
S gene
28.39
28.49
0.1
28.70
0.3
10x LoD
MS2
27.54
28.89
0.3
27.51
0.0
7/7
SARS-CoV-2
Positive
N gene
27.64
27.93
0.3
27.60
-0.04
ORF1ab
27.64
27.94
0.3
27.61
-0.03
S gene
27.68
27.68
0.3
27.65
-0.03
Table 9. Summary of Winter Profile Results
Sample
Gene
Detection
Day 0
Mean
Ct
Value
80
Hours
Mean
Ct
Value
80
Hours
Mean
Ct Diff.
112
hours
Mean
Ct
Value
112
Hours
Mean
Ct. Diff
Number
tested/
Concordant
Results
2x LoD
MS2
29.35
28.97
-0.4
28.85
-0.5
25/25
SARS-CoV-2
Positive
N gene
29.38
29.01
-0.4
28.88
-0.5
ORF1ab
29.37
29.01
-0.4
28.87
-0.5
S gene
29.37
29.01
-0.4
28.87
-0.5
5x LoD
MS2
28.26
27.91
-0.3
27.81
-0.4
8/8
SARS-CoV-2
Positive
N gene
28.37
28.03
-0.3
27.92
-0.4
ORF1ab
28.37
28.02
-0.4
27.92
-0.5
S gene
28.42
28.04
-0.4
27.94
-0.5
10x LoD
MS2
27.72
27.21
-0.5
27.24
-0.5
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N gene
27.77
27.29
-0.5
27.29
-0.4
7/7
SARS-CoV-2
Positive
ORF1ab
27.73
27.31
-0.4
27.27
-0.5
S gene
27.73
27.33
-0.4
27.27
-0.5
PERFORMANCE EVALUATION
1) Limit of Detection (LoD) - Analytical Sensitivity:
The LoD of Kaiser Permanente High Throughput SARS-CoV-2 Assay was evaluated using
gamma-irradiated SARS-CoV-2 obtained from BEI Resources (SARS-CoV-2 isolate USA-
WA1/2020, Item NR-52287) diluted in pooled SARS-CoV-2 negative saliva samples collected
with the Spectrum Solutions, LLC SDNA-1000 Saliva Collection Device.
Preliminary LoD:
The preliminary LoD was determined in a two-phase approach. Phase 1 of the initial estimate of
the LoD was determined by testing six 10-fold dilutions of inactivated SARS-CoV-2 in pooled
negative saliva samples. One RNA extraction at each of the six different target levels, 1.75 to
175,000 copies/mL, was tested using the Kaiser Permanente High Throughput SARS-CoV-2
Assay on the Amplitude System to estimate the range for the LoD.
Phase 2 of the preliminary range finding study involved testing 3-fold dilutions of inactivated
SARS-CoV-2 in pooled negative saliva samples around the concentration determined in the
Phase 1 study. Three individual RNA extraction replicates of five target levels, 19.4, 58.3, 175,
525, and 1575 copies/mL, were tested on the Amplitude System to determine the presumptive
LoD. Spiked saliva specimens were tested according to the Kaiser Permanente High
Throughput SARS-CoV-2 Assay protocol.
Confirmation of the LoD:
The presumptive LoD was confirmed by testing an additional 20 replicates at 525 copies/mL on
seven Amplitude Systems.
The assay LoD was confirmed to be 525 copies/mL in saliva. Table 10 below shows the
summary of mean Ct values at the assay LoD for the Kaiser Permanente High Throughput
SARS-CoV-2 Assay.
Table 10. Summary of overall results from LoD Confirmation at 525 copies/mL
Amplitude
system
Mean Ct values (± SD) for each Amplitude system
N gene
(# positive/ # tested)
ORF gene
(# positive/ # tested)
S gene
(# positive/ # tested)
1
29.2 ± 0.4 (20/20)
28.7 ± 0.4 (20/20)
30.6 ± 0.6 (20/20)
2
30.8 ± 0.6 (20/20)
29.9 ± 0.5 (20/20)
32.3 ± 0.7 (20/20)
3
28.5 ± 0.3 (20/20)
28.1 ± 0.4 (20/20)
30.5 ± 1.1 (20/20)
4
29.2 ± 0.5 (20/20)
28.0 ± 1.1 (20/20)
29.7 ± 0.9 (20/20)
5
30.4 ± 1.2 (20/20)
27.8 ± 1.5 (20/20)
30.7 ± 1.2 (20/20)
6
28.3 ± 2.3 (20/20)
27.8 ± 2.1 (20/20)
29.8 ± 1.8 (20/20)
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29.0 ± 1.0 (20/20)
25.5 ± 2.4 (20/20)
28.2 ± 2.2 (20/20)
2) Inclusivity, Cross-Reactivity and Interfering Substances
SCPMG-RRL has obtained a Right of Reference from Thermo Fisher Scientific, manufacturer
of the TaqPath COVID‑19 High‑Throughput Combo Kit, for data supporting inclusivity, cross
reactivity and interfering substances.
3) Clinical Evaluation
The clinical performance of the Kaiser High Throughput SARS-CoV-2 Assay was evaluated by
testing a total of 300 saliva samples collected under the supervision of a healthcare provider with
the Spectrum SDNA-1000 saliva collection device. Saliva specimens were collected from
symptomatic and suspected of COVID-19 patients who consented to enroll in the study from
August 18, 2020 to November 1, 2020. A corresponding nasopharyngeal (NP) swab was collected
within 10 minutes of saliva collection by a healthcare provider. The NP swab was collected in
either viral transport medium or 0.9% saline and transported with the saliva samples collected in
the SDNA-1000 collection device to the laboratory under ambient conditions. The NP swab was
tested using a highly sensitive FDA authorized molecular assay.
Results for the paired NP swabs were used as the comparator method for calculating positive and
negative percent agreement (PPA and NPA).
Of the 300 saliva specimens tested using the Kaiser High Throughput SARS-CoV-2 Assay, 12
(4.7%) had invalid results. These residual clinical specimens had insufficient volume for
additional repeat testing as instructed in the standard operating procedure and were excluded from
the analysis. The remaining 288 specimens were used for comparative analysis as denoted in
Table 11.
Table 11. Clinical Evaluation Results
NP Swab FDA Authorized Assay Result
Positive
Negative
Total
Saliva
Kaiser High
Throughput SARS-
CoV-2 Assay
Positive
136
6
142
Negative
2
144
146
Total
138*
150*
288
Positive Percent Agreement
98.6% (95% CI, 94.9% - 99.6%)
Negative Percent Agreement
96.0%, (95% CI, 91.5% - 98.2%)
*An inconclusive result for the Kaiser High Throughput SARS-CoV-2 Assay occurs when only one of three
SARS-CoV-2 targets tests as positive. Two comparator positive samples and one negative sample tested as
inconclusive using the Kaiser assay. Inconclusive results were considered discrepant results between the
candidate and comparator assays. There was insufficient residual volume for additional testing.
4) Human Usability Study
To support home use of the Kaiser Permanent Saliva Home Collection Kit, using the Spectrum
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Solutions, LLC SDNA-1000 Saliva Collection Device, a Human Usability Study was conducted
to evaluate the entire workflow including sample collection, labeling the sample, packaging of
the sample, and mailing to the laboratory with pre-paid shipping label. The saliva samples were
collected using the sample collection instructions provided in the SDNA-1000 saliva collection
device and were not subject to change or improvement based on the usability study results.
Testing included 30 adult participants representing varying education levels ranging from high
school education to graduate level degrees and took place in a simulated home environment.
Each participant collected the saliva sample while under observation by a Southern California
Permanente staff, who recorded any difficulties the participant experienced with the sample
collection process. The participants were provided the instructional letter from Kaiser Permanente
including the instructions for use and had access to an instructional video which demonstrates all
aspects of the sample collection workflow. None of the participants in the usability study elected
to watch the instructional video but used only the written instructions provided. The samples were
returned to the lab and evaluated by laboratory staff to determine if the samples were collected,
packaged, and received in the lab correctly.
Thirty out of the 30 samples were received at SCPMG-RRL within 48 hours of saliva collection.
Upon receipt, laboratory personnel inspected the packaging and recorded any packaging errors and
noted acceptability of the sample for testing. All 30 samples were deemed acceptable for testing
based on the evaluation of the sample volume and release of the stabilizing liquid into the sample.
After the entire process was completed, the user was given a questionnaire to indicate the ease of
use of the kit and sample collection. The parameters that were evaluated in the Kaiser Permanente
Saliva Home Collection Kit usability study are listed in Table 12 along with the percentage of
participants who performed each step correctly and without difficulty. Seventeen out of the 30
participants did not experience any difficulty collecting the saliva sample and did not provide any
comments or suggestions on the process.
Table 12. Parameters Evaluated and Performed Correctly
Parameters Evaluated
Percent Performed
Correctly
Open sealed SDNA-1000 device
100% (30/30)
Fill the tube with saliva
100% (30/30)
Replace the funnel
100% (30/30)
Firmly screw cap to release liquid
93% (28/30)
Shake 5 sec
97% (29/30)
Write date and time of collection
90% (27/30)
Label tube and align with existing barcode
93% (28/30)
Wrap in tissue, bag and seal
90% (27/30)
Box bag and letter
97% (29/30)
Place in prepaid shipping bag
100% (30/30)
Ship sample
100% (30/30)
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Upon review of the study results the instructions were updated to address identified difficulties for
the user.
ADDITIONAL REQUIREMENTS
Upon authorization, within 30 days of the receipt of the first home collected sample, SCPMG-
RRL will submit to the FDA a summary of any testing performed with the Kaiser Permanent
Saliva Home Collection Kit including how many kits were prescribed and distributed for
unsupervised collection, how many kits were returned, how many specimens had to be rejected
during accession and the main reasons for rejection, and the positivity rate of the collection
device.
LIMITATIONS
· For 18 years of age or older.
· Negative results for SARS-CoV-2 RNA from saliva should be confirmed by testing of an
alternate specimen type if clinically indicated.
· Performance of this test was not evaluated in an asymptomatic patient population from
individuals suspected of COVID-19 by their healthcare providers.
· The clinical performance of this test has not been established in all circulating variants but is
anticipated to be reflective of the prevalent variants in circulation at the time and location of
the clinical evaluation. Performance at the time of testing may vary depending on the variants
circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which
change over time.
WARNINGS
· For Emergency Use Authorization (EUA) only.
· For in vitro diagnostic use.
· For prescription use.
· This product has not been FDA cleared or approved but has been authorized for emergency use
by FDA under an EUA for use by SCPMG-RRL located at 13000 Peyton Drive, Chino Hills,
CA 91709 which is certified under CLIA and meets the requirements to perform high-
complexity tests.
· This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not
for any other viruses or pathogens.
· 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 diagnostics for
detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug
and Cosmetics Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or
authorization is revoked sooner.
REVOKED