PharmaTech Solutions GenViro! COVID-19 Verifi cation Kit Gebrauchsanweisung

GenViro! COVID-19 Verifi cation Kit
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Instructions for Use
IMPORTANT: Please read this entire pamphlet before using GenViro!
guide demonstrates how to use the GenViro! Verifi cation Kit only. Refer to the Meter User's Manual for complete
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information about your testing kit and how to obtain a reading or result from a sample of saliva.
INTENDED USE
The GenViro! Swift ® COVID-19 Professional System provides real-time Electrochemical Impedance Spectroscopy
(EIS) measurement intended for the presumptive qualitative detection of the SARS-CoV-2 viral particle (antigens) in
saliva samples from individuals with signs and symptoms of infection who are suspected of COVID-19. The concen-
tration of the virus antigens may vary in the course of the disease and might fall below the detection limit (LoD) of
the test. Testing is limited to conduct by health care professionals.
Results are for the identifi cation of SARS-CoV-2 viral particle. Positive results are indicative of active infection.
Laboratories are required to report all positive results to the appropriate public health authorities.
Negative results do not preclude 2019-nCoV infection and should not be used as the sole basis for patient manage-
ment decisions. Negative results must be combined with clinical observations, patient history, and epidemiological
information.
The GenViro! ® COVID-19 Verifi cation Kit is intended for use by health care professionals. The GenViro!
COVID-19 Antigen Saliva Test is only for use under various sovereign agency Emergency Use Authorization(s).
Included in this group of sovereign agencies is the U.S. Food and Drug Administration.
SUMMARY AND EXPLANATION OF THE TEST
An outbreak of respiratory illness of unknown etiology in Wuhan City, Hubei Province, China was initially reported
to WHO on December 31, 2019. Chinese authorities identifi ed a novel coronavirus (2019-nCoV), which has result-
ed in millions of confi rmed human infections e.g. in multiple provinces throughout China, in several Southeast Asian
countries, Europe and the United States.
COVID-19 is transmitted via respiratory droplets that are exhaled by infected people via coughing, sneezing or
talking. These droplets can be inhaled or ingested directly by other people or can contaminate surfaces, which can
then be infectious for several days. Most estimates of the incubation period for COVID-19 range from 1 to 14 days,
during which people might already be infectious without showing disease symptoms
Cases of severe illness and deaths have been reported. The International Committee for Taxonomy of Viruses
(ICTV) renamed the virus SARS-CoV-2.
TEST PRINCIPAL
The GenViro! COVID-19 Antigen Saliva Test is based on electrochemical impedance spectroscopy measurement
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in saliva samples to determine the presence of the COVID-19 (SARS-Cov-2) virus. The GenViro!
mainly detects the SARS-Cov-2 nucleo-protein (nucleocapsid).
MATERIALS PROVIDED
• GenViro! ® COVID-19 Adapter (Interface sleeve)
• GenViro! ® COVID-19 Test Strip
• The package insert
STORAGE AND HANDLING
• Do not use your GenViro! ® Verifi cation Kit if the packaging has been damaged or opened. This could cause
incorrect test results or incorrect meter messages.
• Store test strips in a cool, dry place between 50°F - 104°F (10°C - 40°C). Do not refrigerate. Do not freeze. Do
not expose to direct sunlight or heat. Extreme temperatures or humidity may cause inaccurate readings.
• Each box of test strips has an expiration date printed on it. Do not use test strips beyond the expiration date.
• Never get food, dirt or liquids on the test strip. Use only clean hands to touch the test strip. The test strip may
be touched anywhere on its surface with clean, dry hands.
• Never bend, cut, damage, or change the test strips in any way.
• Use each test strip only once.
• Use one adapter per patient. The adapter should be discarded after use on each patient.
• Your meter, adapter, and test strips should be about the same temperature when you test.
WARNINGS
• Test strips and adapter are a choking hazard. Keep away from children. Do not swallow test strips or adapter.
PRECAUTIONS
• Make sure your Meter is set correctly. Refer to your Meter instructions for setting up the meter and checking
the system.
• Wear appropriate personal protective equipment during test procedure.
• If you have symptoms that are not consistent with your test results and you have ruled out common errors
described in instructions for your test strips and Meter, call your health care professional immediately.
• Do not change your treatment or ignore your symptoms without calling your healthcare professional.
• For professional in-vitro diagnostic use only.
PERFORMING A TEST
NOTE: In addition to the GenViro! COVID-19 Verifi cation Kit, you will need the GenViro! Swift
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instructions, the diluent and the sample collection funnel and tube.
NOTE: Read Meter instructions for details about using the meter.
Collect a sample
Step #1:Wash your hands with warm, soapy water. Dry thoroughly.
Step #2: Use the saliva collection funnel and tube to collect a sample. It may take 2-3 attempts to reach the
req uired minimum volume, about 1.5mL.
Step #3: Add 1.0mL saline solution to the sample vial. Remove funnel, and screw cap tightly. Gently swirl the
solution for 5 seconds.
Performing the Test
NOTE: Read Meter instructions for details about using the meter.
Step #1: Remove adapter and test strip from packaging. Insert test strip into test
strip slot of adapter as illustrated. (See 1 st Diagram.)
Insert adapter into adapter slot of the meter with the contact bars facing up. The
meter will turn on automatically. (See 2 nd Diagram.)
Step #2: The meter will show when it is ready to receive a sample. Refer to your
Meter instructions.
Step #3: Touch the surface of the sample to the narrow channel at the tip of the
test strip. (See 3 rd Diagram.)
• If the strip does not fi ll, remove strip and obtain a new strip and insert into the
meter. If the window is not full, you may get an inaccurate reading or a Meter
error message. If you have a problem fi lling the test strip, contact GenViro!
Customer Service for help.
• Do not apply the sample to the top surface or underside of test strip. Do not
submerge the strip against the sample. Do not fl ick the test strip.
• When the strip is full, the meter will "beep. " Hold the test strip to sample until
you hear a beep. If you do not hear a beep, you may get an inaccurate reading or
a meter error message.
Step #4: Test result will show up in 10 seconds.
Step #5: Dispose of the adapter, test strips, and saliva collection tube safely in a
puncture resistant container.
Test Results
Your Meter can display results from 0-999 (Impedance value).
If your results are not what you expect, retest. If your symptoms are not consistent
with your test results contact your healthcare professional immediately.
GenViro_VerificationKit_Insert_20210629.indd 1 GenViro_VerificationKit_Insert_20210629.indd 1
® COVID-19 Verifi cation Kit. This reference
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® Covid-19 test
Meter, meter
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EXPECTED VALUES
Instrument Display Interpretation of Results and Follow-up Actions
"Present": COVID-19 Positive | Positive results do not rule out bacterial infection or
co-infection with other viruses.
"Not Present": COVID-19 Negative | This result does not rule out co-infections with
other pathogens.
"Err": COVID-19 Invalid | The presence or absence of COVID-19 Virion cannot be
determined. Repeat testing of the patient using a new test strip. If repeated Invalid
results are obtained, results should be confi rmed by another method prior to
reporting the results.
LIMITATIONS
• Do not use with newborns.
• Both viable and non-viable SARS-CoV-2 viruses can be detected using the GenViro!® Covid-19 test.
• Positive and negative predictive values are highly dependent on prevalence. The local prevalence should be taken
into consideration when interpreting diagnostic test results.
• If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is
recommended. A negative result does not at any time preclude the possibility of a SARS-CoV-2 infection and
should be confi rmed via molecular assay.
• As with all diagnostic tests, all results must be combined with clinical observations, patient history, and epidemi-
ological information available to the physician.
INFECTION CONTROL
Treat all patient samples and materials they contact as biohazards. Use universal saliva handling precautions. Dispose
of all materials as per local regulations. Handle all specimens as if they contain infectious agents.
CAUTION: T o reduce the chance of infection:
• Do not share a strip, funnel or tube.
• Use strip only once.
• Always use a new kit.
• Keep Meter and kits clean.
PERFORMANCE CHARACTERISTICS
Clinical Study
The performance characteristics of the test were evaluated with a total of 473 saliva samples and confi rmed
by the RT-qPCR.
GenViro! ® COVID-19 (SARS-Cov-2) Antigen Saliva Test - Clinical Evaluation
Number Tested Virus Result
232 positive samples Sensitivity
241 negative samples Specifi city
473 Total Positive Predictive Value
Negative Predictive Value
Total Accuracy
ANALYTICAL STUDIES
Limit of Detection (LoD)
The 95% detection limit of the GenViro! ® COVID-19 Antigen Saliva Test is 10
dilution of inactivated SARS-Covid-2 virus. This is the lowest load of antigen concentration that could be distin-
guished 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
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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. GenVi-
ro! Covid-19 test can differentiate between SARS-CoV und SARS-CoV-2.
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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
Interference Substances reaction
A dilution of SARS-CoV-2 (2.8 x 10 4 TCID /mL) was added to the following substances, which are normally present
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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! ® Covid-19 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
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 +1-844-
874-2762 or German Customer Service at 0049-170-636 2352. If you need help at other times, please call your
healthcare professional.
GenViro! and GenViro! Swift are registered trademarks of © Pharma Tech Solutions, Inc.
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GenViro! Swift Meter and GenViro!
®
Pharma Tech Solutions Inc., 2660 Townsgate Rd Suite 300, Westlake Village, CA 91361 USA
www.pharmatechsolutions.co info@pharmatechsolutions.co
Rev No 001 Rev Date: 06/2021
EU representative:
Pedima International GmbH, Jaegerhofstrasse 16, 40479 Duesseldorf, Germany
www.pedima.international
Result % [95% CI]
87.60% [82.79% - 91.24%]
97.21% [93.73% - 98.86%]
97.41% [95.37% - 99.46%]
86.72% [82.44% - 91.01%]
92%
1 TCID /mL and was determined via
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3 CEID
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3 CEID
50
3 CEID
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Kit are manufactured for and distributed by:
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info@pedima.international
02-25-2021
April 2021
6/29/2021 8:59:12 AM 6/29/2021 8:59:12 AM
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