CLINITEST® Rapid COVID-19 Antigen Test FAQ Job Aid

CLINITEST® Rapid COVID-19 Antigen Test FAQ Job Aid Stability How long is the test cassette stable outside of the sealed pouch? One hour maximum; Test cassettes that have been outside of the sealed pouch for more than 1 hour should be discarded. What is the shelf life of the product? The shelf life is 24 months from the date of manufacture. How long after swab collection can the specimen remain untested? Specimen should be tested immediately after collection. If immediate testing of specimen is not possible, insert the swab into an unused general-purpose plastic tube. Ensure the breakpoint swab is level with the tube opening. Bend the swab shaft at a 180 degrees angle to break it off at the breaking point. Ensure the swab fits within the plastic tube and secure a tight seal. The specimen should be disposed and recollected for retesting if untested for longer than 1 hour. Sample in extraction buffer should be utilized immediately. What are the shipping and storage requirements of the test and what affect could this have on the result if violated? The kit can be stored and shipped at room temperature or refrigerated (2-30°C). Discard tests if outside of these thresholds. Product shelf-life is 24 months; expiration date is stated on the out- side of kit and is the date that should be used for reference. What if the incubation time is exceeded for the swab in the extraction buffer? How long is acceptable? Per the IFU, test should be run immediately following the 1 minute incubation period; only 1 minute is acceptable. When one stores a swab to preserve can VTM be used? No, VTM/UTM is not recommended/supported (potential with diluting samples and false posi- tives in certain VTMs). Specimen should be tested immediately after collection. If immediate testing of specimen is not possible, insert the swab into an unused general-purpose plastic tube. Ensure the breakpoint swab is level with the tube opening. Bend the swab shaft at a 180 degrees angle to break it off at the breaking point. Ensure the swab fits within the plastic tube and se- cure a tight seal. The specimen should be disposed and recollected for retesting if untested for longer than 1 hour. Sample in extraction buffer should be utilized immediately. Unrestricted | Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 SIEMENS Master Template Effective Date: 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: 29-MAR-2021 | HOOD05162003179873 Healthineers Job Aid | CLINITEST Rapid COVID-19 Antigen Test FAQ Effective Date: 29-MAR-2021 | HOOD05162003179873 Testing Process Where must the CLINITEST Rapid COVID-19 test be administered? The test must be administered by a healthcare professional in these locations. Nasal specimens can be collected by the patient under direct supervision of a healthcare professional. For retesting of an invalid (no control line) result, should a new specimen be collected with a new swab or can the remaining extraction solution be used? The specimen should be re-tested by collecting a new sample with a new swab and using a new tube, buffer solution, and cassette. What are possible reasons for an invalid (control line failure) result? Potential reasons for a control line failure are insufficient sample volume, incorrect operating procedure, expired components, or not following the directions correctly. What happens if any of the test materials are not at room temperature when the test is performed? Materials used for testing that are not at room temperature can lead to inaccurate results; this is because the materials perform differently outside of the 15-30°C temperature range. Allow the test cassette, sample swab, extraction tubes, and buffer to equilibrate to room temperature (15- 30°C) prior to testing. What happens if there are too many drops of extraction buffer added to the extraction tube? The IFU states “Add 0.3 mL (approximately 10 drops) of the sample extraction buffer into the ex- traction tube”. An extra 1 or 2 drops does not affect the performance of the test. Is it acceptable if the user adds more than 4 drops of the test sample solution added to the sample well on the test cassette? Per the IFU, exactly 4 drops of sample solution should be dispensed into the sample well. If the control line is faint, is that a concern? No, as long as there is a control line present, there is no concern. What are the criteria for retesting a patient? For an invalid test result (no “C” line) repeat the test; For any retesting of a patient after a nega- tive or positive results follow your country’s government’s guidance on COVID-19 infection. Unrestricted | Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 SIEMENS Master Template Effective Date 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: 29-MAR-2021 | HOOD05162003179873 Healthineers Page 2 of 6 Job Aid | CLINITEST Rapid COVID-19 Antigen Test FAQ Effective Date: 29-MAR-2021 | HOOD05162003179873 During the 15 minutes incubation, is the test cassette sensitive to orientation? The test cassette should be run on a flat surface; placing the cassette at an angle can alter the sensitivity and affect results. Can incubating cartridges be placed side by side? Can multiple testing of patients be per- formed? Yes, following good laboratory practice and technique to ensure samples are not cross contami- nated. Can I use the lines on the extraction tube to measure the buffer solution? Extraction tube lines are not utilized for this test; volume of extraction buffer should be deter- mined by the measurements stated in the instructions. Is there a concern that the ten drops of buffer solution in the extraction tube do not fully submerge the head of the cotton swab? The instructions in the IFU should be followed as stated. The swab should be rolled at least 6 times while pressing the head against the bottom and side of the extraction tube and then after the 1 minute incubation, the tube should be squeezed to fully submerge the swab. Should one shake the buffer before use? No, this may generate bubbles and result in incorrect drop sizes. Does this test distinguish between SARS-CoV and SARS-CoV-2? As stated in the IFU, this test does not distinguish between SARS-CoV and SARS-CoV-2. The amino acid sequence of the SARS-CoV and SARS-CoV-2 Nucleocapsid protein is 90% identical. The CLINITEST Rapid Ag Test IFU states this cross reactivity, while some vendors do not mention it in their product literature. What happens to the test results after 20 minutes? After 20 minutes the cassette can provide an invalid or false result. Can water be used instead of the buffer solution? No. Water should not be used to perform the test. What sample types can be used? Nasopharyngeal or anterior (frontal) nasal specimens can be used. The sterile swab included in the kit can be used for either sampling method. Anterior nasal specimen collection claims were added to version 5 of the instructions for use. Unrestricted | Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 SIEMENS Master Template Effective Date 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: 29-MAR-2021 | HOOD05162003179873 Healthineers Page 3 of 6 Job Aid | CLINITEST Rapid COVID-19 Antigen Test FAQ Effective Date: 29-MAR-2021 | HOOD05162003179873 Is it possible to use CLINITEST Rapid Antigen Test with nasal, oropharyngeal, or saliva samples? Only nasopharyngeal and anterior swab samples are supported at this time. CLINITEST COVID-19 Antigen Controls Who is the legal manufacturer of the CLINITEST COVID-19 Antigen Controls? Healgen Scientific is the legal manufacturer; the kit is distributed by Siemens Healthineers. How long is the swab stable outside of the sealed pouch? The swab must be used within 2 hours of opening the sealed pouch. Ideally the swab should remain in the sealed pouch until use. What is included in the CLINITEST COVID-19 Antigen Control Kit? The kit includes 5 negative swabs (blue) and 5 positive control swabs (red); this is the only configuration available for sale. Healgen Scientific offers a kit consisting of 10 negative/10 positive, but only packs of 5 negative/5 positive are available for sale through Siemens Healthineers. What are the shipping and storage requirements of the kit and what affect could this have on the result if violated? The kit can be stored and shipped at room temperature or refrigerated (2-30°C). Discard tests if outside of these thresholds. The swab is stable through the expiration date printed on the sealed pouch. The swab must remain in the sealed pouch until use. Do not freeze. What happens if any of the test materials are not at room temperature when the test is performed? Materials used for testing that are not at room temperature can lead to inaccurate results; this is because the materials perform differently outside of the 15-30°C temperature range. Allow the test device, controls, and buffer to equilibrate to room temperature (15-30°C) prior to testing. Unrestricted | Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 SIEMENS Master Template Effective Date 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: 29-MAR-2021 | HOOD05162003179873 Healthineers Page 4 of 6 Job Aid | CLINITEST Rapid COVID-19 Antigen Test FAQ Effective Date: 29-MAR-2021 | HOOD05162003179873 What are possible reasons for an invalid (control line failure) result? If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results include failure to correctly follow directions or the test was used beyond the expiration date. It is recommended that the control swab be re- tested using a new test device. What are the control swabs composed of? The negative control swab is composed of negative control buffer dried onto a swab containing a preservative. The positive control swab is composed of a SARS-CoV-2 recombinant antigen extract dried onto a swab containing a preservative. The preservative is 0.1% sodium azide. Can one contract the virus from the positive control swab? No. Recombinant antigens are manufactured artificially and cannot reproduce and cause an infectious disease once they infect a target cell. However, all the specimens should be considered potentially hazardous and handled in the same manner as an infectious agent. What type of rapid COVID-19 antigen test can one use with CLINITEST COVID-19 Antigen Controls? The CLINITEST COVID-19 Antigen Control Kit should only be used with the CLINITEST Rapid COVID-19 Antigen Test. Incompatibilities between this product and other manufacturers test kits may occur. How often should one run QC? Is it mandatory? The CLINITEST Rapid COVID-19 Antigen Test IFU does not mandate the use of quality controls. QC should be performed in accordance with applicable local, state, and/or federal regulations. Can VTM be used to preserve a control swab? No, VTM/UTM is not recommended as per the CLINITEST Rapid COVID-19 Antigen Test IFU. Control swabs should be tested immediately after opening the sealed pouch. Unrestricted | Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 SIEMENS Master Template Effective Date 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: 29-MAR-2021 | HOOD05162003179873 Healthineers Page 5 of 6 Job Aid | CLINITEST Rapid COVID-19 Antigen Test FAQ Effective Date: 29-MAR-2021 | HOOD05162003179873 Please note that the learning material is for training purposes only. For the proper use of the test kits, please always use the Instructions for Use issued by the manufacturer, Healgen Scientific. This material is to be used as training material only and shall by no means substitute the Instructions for Use. Any material used in this training will not be updated on a regular basis and does not necessarily reflect the latest version of the test kits available at the time of the training. Certain products, product related claims or functionalities (hereinafter collectively “Functionality”) may not (yet) be commercially available in your country. Due to regulatory requirements, the future availability of said Functionalities in any specific c ountry is not guaranteed. The reproduction, transmission or distribution of this training or its contents is not permitted without express written authority. Offenders will be liable for damages. All names and data of patients, parameters and configuration dependent designations are fictional and examples only. All rights, including rights created by patent grant or registration of a utility model or design, are reserved. Copyright © Siemens Healthcare GmbH 2021 Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen, Germany Phone: +49 9131 84-0 siemens-healthineers.com Unrestricted | Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 SIEMENS Master Template Effective Date 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: 29-MAR-2021 | HOOD05162003179873 Healthineers Page 6 of 6