Performance Characteristics - PharmaTech Solutions GenViro! Swift Gebrauchsanweisung

PERFORMANCE CHARACTERISTICS

Clinical Study
The performance characteristics of the test were
evaluated with a total of 440 saliva samples and
confi rmed by the RT-qPCR.
GenViro! ® COVID-19 (SARS-Cov-2) Anti-
gen Saliva Test - Clinical Evaluation
Number Result Result % [95% CI]
Tested Virus
232 positive Sensitivity 87.60% [82.79% - 91.24%]
samples
241 negative Specifi city 97.21% [93.73% - 98.86%]
samples
473 Total Positive Predictive 97.41% [95.37% - 99.46%]
Value
Negative Predictive 86.72% [82.44% - 91.01%]
Value
Total Accuracy 92%
ANALYTICAL STUDIES
Limit of Detection (LoD)
The 95% detection limit of the GenViro! ®
COVID-19 Antigen Saliva Test is 10 1 TCID /mL
50
and was determined via dilution of inactivated
SARS-Covid2 virus. This is the lowest load of
antigen concentration that could be distinguished
by the GenViro! COVID-19 test from the
®
absence of that substance with the stated 95%
confi dence level.
Cross Reactivity
GenViro! ® COVID-19 Analytical Specifi city
Microorganisms
The negative and positive saliva samples were
treated with the following pathogens and tested
with GenViro! ® Covid-19 Antigen Saliva test.
There was no effect on the test results and
no cross-reactions were observed. GenViro!
Covid-19 test can differentiate between SARS-
CoV and SARS-CoV-2.
Human coronavirus 229E concentration 450 µg/mL
Human coronavirus OC43 concentration 450 µg/mL
Human coronavirus NL63 concentration 450 µg/mL
Human coronavirus HKU1 concentration 50 µg/mL
MERS coronavirus concentration 1.25 µg/mL
8 - GenViro! Swift COVID-19 User Guide
®
GenViro_INT_Saliva_POC_Meter_UserGuide_20210629.indd 8-9 GenViro_INT_Saliva_POC_Meter_UserGuide_20210629.indd 8-9
Interference Substances reaction
A dilution of SARS-CoV-2 (2.8 x10 TCID
4
was added to the following substances, which
are normally present in saliva in the throat and
mouth area, at the indicated concentrations.
When testing the saliva samples mixed with the
substances/dilution-mix with GenViro!
Antigen Saliva test the following substances
showed no interference:
Infl uenza A H1N1 virus concentration 2.8×10
Infl uenza A H3N2 virus concentration 2.8×10
Infl uenza A H5N1 virus concentration 250 µg/mL
Infl uenza A H7N9 virus concentration 400 µg/mL
Infl uenza B concentration 2.8×10
Respiratory syncytial virus type A/B concentration 1/40 diluted
References:
1. Centers for Disease Control and Prevention. https://
www.cdc.gov/coronavirus/2019-ncov/index.html.
Accessed February 9, 2020.
2. bioRxiv. (https://www.biorxiv.org/content/10.1101/
2020.02.07.937862v1). Accessed March 3, 2020.
3. Manual of Clinical Microbiology, 11th Edition, Vol. 1,
ASM. (2015) pg. 279.
SYMBOLS
Use by / Expiry
Batch code
date
Temperature
Biological risks
limitation
Caution Manufacturer
Please consult
instructions Do not reuse
for use
® In vitro diagnostic Keep away from
Medical Device sunlight
Serial number CE-marking
Display Messages and Problem-Solving
Guide
/mL)
50
When any of the following messages appears,
there is a problem with your GenViro! Swift
Meter or the way in which you are performing
a test. These messages will help you to identify
Covid-19 certain problems. If error messages appear that
®
are not listed on the following pages, contact
customer service for help.
CEID Display
3
50
3 CEID
50
3 CEID
50
No responses when strip is
inserted into the meter.
No responses when sample is
applied to the strip.
ORDERING and CONTACT INFORMA-
TION
CUSTOMER SERVICE
®
It is our goal to provide you with exceptional
customer service. If you are not satisfi ed with
this product, or for any other reason wish to
reach our Customer Service representatives,
please call US Customer Service at 001-844-874-
2762 or German Customer Service at 0049-170-
636 2352. If you need help at other times, please
Description/ Action to Take
call your healthcare professional.
GenViro! ® and GenViro! Swift
Display check
trademarks of Pharma Tech Solutions, Inc.
If some parts of the display are
GenViro! Swift ® Meter & GenViro!
not working. Contact customer
service for help.
manufactured for and distributed by:
Pharma Tech Solutions Inc., 2660 Townsgate Rd
Suite 300, Westlake Village, California 91361 USA
www.pharmatechsolutions.co
Battery is low.
info@pharmatechsolutions.co
To minimize contamination risk,
Rev No 001 Rev Date: 06/2021
do not replace battery. Safely
dispose of meter and replace
EU representative:
with a new meter..
Pedima International GmbH, Jaegerhofst-
rasse 16, 40479 Duesseldorf, Germany
Temperature is above or below
www.pedima.international
the operating range of test strips
and meter.
info@pedima.international
The result you have obtained
may not be accurate. Move to an
area with temperature between
4°C - 30°C (40°F - 86°F). Do
not artifi cially heat or cool
the meter.
02-25-2021
Test strip unknown or may be
damaged.
Perform the test with new
test strip.
April 2021
Test strip is used or test was not
performed correctly.
Perform the test with a new
test strip and follow the test
procedure correctly.
Maybe:
1. Battery is dead.
2. Wrong strip was inserted.
3. Meter is defective.
You have to:
1. Replace the meter.
2. Insert the test strip correctly.
3. Contact customer service
for help.
Maybe:
1. Sample volume is not suffi cient.
2. Meter is defective.
You have to:
1. Repeat test with suffi cient
sample.
2.Contact customer service
for help.
GenViro! Swift
® are registered
® Kit are
COVID-19 User Guide - 9
®
6/29/2021 9:12:17 AM 6/29/2021 9:12:17 AM