Product Manual

4 (6)
1. Authorized laboratories* 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
2. Authorized laboratories using your product must use your product
as outlined in the Instructions for Use. Deviations from the
authorized procedures, including the authorized clinical
specimen types, authorized control materials, authorized other
ancillary reagents and authorized materials required to use your
product are not permitted.
3. Authorized laboratories that receive your product must notify the
relevant public health authorities of their intent to run your
product prior to initiating testing.
4. 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.
5. Authorized laboratories must collect information on the
performance of your product and report to DMD/OHT7-
OIR/OPEQ/ CDRH (via email:
CDRH-EUA-
[e-mail]) and Salofa Oy ([e-mail]) 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.
6. All laboratory personnel using your product must be appropriately
trained in immunoassay techniques and use appropriate
laboratory and personal protective equipment when handling this
kit and use your product in accordance with the authorized
labeling. All laboratory personnel using the assay must also be
trained in and be familiar with the interpretation of results of the
product.
7. Salofa Oy, 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.
*The letter of authorization refers to, “Laboratories certified under the
Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42
U.S.C. §263a, that meet requirements to perform moderate or high
complexity tests. The Clarity COVIBLOCK
TM
COVID-19 IgG/IgM Rapid
Test Cassette is also authorized for use with fingerstick whole blood
specimens only 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”.
PERFORMANCE CHARACTERISTICS
The Clarity COVIBLOCK
TM
COVID-19 IgG/IgM Rapid Test Cassette
was compared against PCR confirmed results in 3 studies.
Study 1: In the first retrospective study, 70 positive and 10 negative
plasma samples (EDTA) collected from China were tested. All
nasopharyngeal samples were confirmed using the Novel Coronavirus
2019-nCoV Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
(US FDA EUA authorized). Plasma samples were collected using
EDTA anticoagulant and stored at -20°C until tested.
Study #1: IgG Positive Agreement Result
Days between date of
PCR comparator test
and collection of
plasma/serum sample
Number
of
Samples
Tested
IgG
Positive
results
IgG
PPA
95% CI
0-7 days 68 57 83.82%
73.31%-
90.72%
8-14 days 2 2 100%
34.24%-
100%
≥15 days
0
0
N/A
N/A
Study #1: IgM Positive Agreement Result
Days between date of
PCR comparator test
and collection of
plasma/serum sample
Number
of
Samples
Tested
IgM
Positive
results
IgM
PPA
95% CI
0-7 days 68 61 89.71%
73.31%-
90.72%
8-14 days 2 2 100%
34.24%-
100%
≥15 days
0
0
N/A
N/A
Study #1: IgG Negative Agreement Result
Number of
Samples Tested
Combined IgG &
IgM Negative
NPA 95% CI
results
10
10
100%
72.25%-100%
Study 2: In the second retrospective study, 113 positive plasma
samples (EDTA) and 50 negative serum samples collected from China
were tested. All nasopharyngeal samples were confirmed using
COVID-19 (ORF 1ab/N) Nucleic Acid Detection Kit (Double fluorescent
PCR) (Limit of Detection: 1000 copies/mL). All samples were collected
and stored at -20°C until tested.
Study #2: IgG Positive Agreement Result
Days between date of
PCR comparator test
and collection of
plasma/serum sample
Number
of
Samples
Tested
IgG
Positive
results
IgG
PPA
95% CI
0-7 days
0
0
N/A
N/A
8-14 days
0
0
N/A
N/A
≥15 days
60
60
100%
93.98%
-100%
Study #2: IgM Positive Agreement Result
Days between date of
PCR comparator test
and collection of
plasma/serum sample
Number
of
Samples
Tested
IgM
Positive
results
IgM
PPA
95% CI
0-7 days
0
0
N/A
N/A
8-14 days
0
0
N/A
N/A
≥15 days 60 56 93.33%
84.07%-
97.38%
Study #2: IgG Negative Agreement Result
Number of
Samples Tested
Combined IgG &
IgM Negative
results
NPA 95% CI
50
50
100%
92.81%-100%
Study 3: In the third prospective study, 75 negative fingerstick whole
blood samples and 30 positive fingerstick whole blood samples
collected from the US were tested. All nasopharyngeal samples were
confirmed using the NxTAG CoV Extended Panel Assay (US FDA
EUA Authorized). All samples were collected and tested immediately
by non-laboratory healthcare professionals.
Study #3: IgG Positive Agreement Result
Days between onset
of symptoms and
collection of
fingerstick whole
blood sample
Number
of
Samples
Tested
IgG
Positive
results
IgG
PPA
95% CI
0-7 days
0
0
N/A
N/A
8-14 days
0
0
N/A
N/A
≥15 days
30
28
93.3%
78.7-
98.2%
Study #3: IgM Positive Agreement Result
Days between onset
of symptoms and
collection of
fingerstick whole
blood sample
Number
of
Samples
Tested
IgM
Positive
results
IgM
PPA
95% CI
0-7 days
0
0
N/A
N/A
8-14 days
0
0
N/A
N/A
≥15 days
30
25
83.3%
66.4-
92.7%
Study #3: IgG Negative Agreement Result
Number of
Samples Tested
Combined IgG &
IgM Negative
results
NPA 95% CI
75
75
100%
92.81%-100%
SEROCONVERSION
A retrospective clinical study was performed, with a total of 81 serum
samples collected from 30 patients who were confirmed for SAR-CoV-
2 infection using PCR. Days between symptom onset and blood
collection date were categorized in 3 groups: 0-7 days, 8-14 days and
greater than 15 days.
ET