Proof Lab User Manual COV I D - 1 9 T E ST For Use Under an Emergency Use Authorization (EUA) Only © Copyright 2021 Proof Diagnostics, Inc.
General Information Please review the contents of our User Manual. Contact Proof Diagnostics’ Customer Support Team at support@proofdx.com, if you have any questions. Copyright This User Manual and all the contents contained are subject to copyright. All rights are reserved. No part of this user manual may be reproduced, copied, translated or transmitted in any form or by any means without the prior written approval of Proof Diagnostics. Manufacturer PROOF DIAGNOSTICS, INC.
Table of Contents General Precautions and Safety Instructions ��������������� 1 General Precautions 1 General Safety 2 Biohazards 2 Introduction ��������������������������������������������������������������������������� 3 About 3 Intended Use 3 Principles of the Procedure 4 Operation ������������������������������������������������������������������������������� 5 Package Contents Required Materials Quality Controls 5 5 6 Internal Control 6 External Positive and Negative Controls
Reader Maintenance ����������������������������������������������������������� 25 Cleaning the Reader 25 Updating Reader Firmware 25 Error Alerts ����������������������������������������������������������������������������� 26 Technical Specifications ����������������������������������������������������� 27 Table of Symbols ������������������������������������������������������������������ 28 Regulatory Notices ������������������������������������������������������������� 29 Support ����������������
• Inadequate or inappropriate sample collection, storage and transport may yield false test results. Introduction • Please follow the instructions provided in this manual to obtain accurate results. Ensure the Proof Lab Reader and Test Kit are maintained at room temperature: 15 to 30°C (59 to 86°F). About • Ensure the Proof Lab Reader and Test Kit are maintained at room temperature: 15 to 30°C (59 to 86°F).
information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. Testing facilities within the United States and its territories are required to report all positive 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.
Test Kit Storage and Use Quality Controls Internal Control The COVID-19 Test Kit also includes an Internal Control for the presence of human RNA. Human beta-actin primers are included in the Proof Cartridge amplification reaction to ensure the presence of human cellular RNA in the test sample and are used in determining the final test result. External Positive and Negative Controls Proof Diagnostics recommends positive and negative controls be purchased separately from ZeptoMetrix (Buffalo, NY).
Basic Setup • The Proof Lab should be placed on a dry, level surface with clear access to a suitable power outlet. • Make sure the workspace around the Proof Lab is kept clean and free of contaminates. Prepare Proof Lab Running a Test Before running a test, make sure: • You have read and understood all of the instructions contained in this User Manual including all safety warnings and cautions. • You have powered on the Proof Lab, and it is ready to run a test (see “Prepare Device” on page 8).
3. Fully open Cartridge door to expose Cartridge porthole. 4. Write the Patient ID on the removable label found on the Sample Vial pouch. Remove and attach to the Vial. 7. Remove the Nasal Swab from its packaging. 8. Insert the entire soft tip of the Swab inside the nostril until the tip is no longer visible. If the Swab meets with any resistance, do not insert any further. Firmly rotate the Swab in a circular path against the nasal wall 2-3 times. Repeat in the other nostril using the same Swab. 9.
11. Pick up the Exact Volume Transfer Pipette by the top bulb and squeeze the top bulb firmly between your forefinger and thumb. 15. Replace cap on Vial and retain until the test has returned a conclusive result. 16. Discard the Pipette in a biohazard waste bin. 12. While still squeezing firmly on the top bulb, fully submerge the Pipette tip into the Vial liquid, so that Pipette tip is near the bottom of Vial. 13. Gently release the top bulb to allow the liquid to fill the Pipette stem.
Test Result Interpretation When the test is complete, the result will be shown on both the Proof Lab display and the Test Cartridge. 19. Firmly close the lid of the Proof Lab. When the lid is closed, the Proof Lab will detect the presence of the Cartridge. Proof Lab Display When the test is complete, the result will appear on the Proof Lab display. Record the test result shown on the Proof Lab. 20. When the Cartridge is detected, the test will begin. DO NOT OPEN THE LID WHILE THE TEST IS RUNNING.
IF THE TEST RESULT IS NEGATIVE, SARS-COV-2 HAS NOT BEEN DETECTED • Negative test results are not intended to rule out other non-SARS viral or bacterial infections. Negative Result: COVID-19 has not been detected in the tested sample. Although highly accurate, there is a small possibility that the test will give a false negative reading.
Conditions for Authorization The Proof Diagnostics COVID-19 Test Letter of Authorization1, along with the authorized Fact Sheet for Healthcare Providers, the authorized Fact Sheet for Patients and authorized labeling are available on the FDA website: https://www.fda.gov/medical-devices/coronavirus-disease2019-covid-19-emergency-use-authorizations-medical-devices/vitrodiagnostics-euas.
Patient Demographics The performance of the Proof Diagnostics COVID-19 Test was established with [#] nasal swabs collected from individual symptomatic patients and asymptomatic at risk individuals who were suspected of COVID-19 under Institutional Review Board approval and Informed Consent. Retrospective COVID-19 Positive and Negative Samples were included in the clinical study two weeks after prospective enrollment of subjects. These clinical specimens are included in the study data.
Analytical Reactivity (Inclusivity) The inclusivity of the Proof Diagnostics COVID-19 Test was evaluated using in silico analysis of the assays primers and probes in relation to [#] SARS-CoV-2 sequences available in the GISIAD gene database for N gene. Results TBD Analytical Specificity (Cross-Reactivity or Exclusivity) Analytical specificity of the Proof Diagnostics COVID-19 Test was evaluated by preparing triplicate negative nasal swabs spiked with each of the cross-reactivity organisms listed below.
Interfering Substances The Proof Diagnostics COVID-19 Test was evaluated for performance in the presence of potentially interfering substances that might be present in a respiratory specimen. Negative specimens were evaluated in triplicate to confirm that the substances were not cross-reactive with the test. Specimens containing SARS-CoV-2 at a concentration near the limit of detection were also evaluated in the presence of the substances in triplicate to confirm that SARS-CoV-2 could still be detected.
Error Alerts Technical Specifications PROOF LAB SPECIFICATIONS ERROR STATE 1 – POWER ON ERROR What to do 1. Record Invalid result, then open lid. 2. Remove Cartridge from the Proof Lab and note if the result label is punched as Invalid. If so, record test result. Close lid. Wait 30 seconds for Proof Lab to return to Ready state. If the display returns to the Ready state, start a new test. 3. Close lid. Wait 30 seconds for Proof Lab to return to Ready state.
Table of Symbols Regulatory Notices The following symbols are used on the Proof Lab and COVID-19 Test Kit packaging. [All symbols TBC] Declaration of Conformity Manufacturer This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: 1. This device may not cause interference. 2. This device must accept any interference, including interference that may cause undesired operation of the device.
Support (TBD) Warranty The Proof Lab shall maintain accuracy over its lifetime (for at least 3 years) after post-manufacturing checks. Disposal Please ensure the proper disposal of the Proof Lab according to all relevant local laws. Plastic and electronic components should be disposed of at a recycling facility. Please refer to your local regulations regarding the proper disposal of electronic devices.
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