Bon Secours Mercy Health Richmond HealthPartners Laboratories RSV on Abbott ID Now PDF (Micro-Micro-0165) 2024

Bon Secours Mercy Health Richmond HealthPartners Laboratories Title: RSV on Abbott ID Now Number: Micro-Micro-0165 Revision: 3.0 Approval Date: 6/28/2024 Approved By: Clifton Bridges Laboratory Director SMH RGH (CLBRIDGE) Review Date: 6...

Bon Secours Mercy Health Richmond HealthPartners Laboratories Title: RSV on Abbott ID Now Number: Micro-Micro-0165 Revision: 3.0 Approval Date: 6/28/2024 Approved By: Clifton Bridges Laboratory Director SMH RGH (CLBRIDGE) Review Date: 6/28/2024 Reviewed By: Clifton Bridges Laboratory Director SMH RGH (CLBRIDGE) Micro-Micro-0165 RSV on Abbott ID Now Copy of version 3.0 (approved and current) Last Approval or Uncontrolled Copy printed on 12/12/2024 12:14 6/28/2024 Periodic Review Completed PM Next Periodic Review Leetta Bateman Lead MLS 6/28/2025 Printed By Needed On or Before (lcbatema) Effective Date 6/28/2024 Organization Richmond Market Author y CURTIS PFOHL Approval and Periodic Review Signatures o p MP Type Approval Description Lab Director Date 6/28/2024 Version 3.0 Performed By c :1 4 Clifton Bridges Laboratory Director SMH RGH (CLBRIDGE) Notes Approval Laboratory Director CEC 6/28/2024 3.0 d 12 Lindsey Matthews Laboratory Director (MATT0083) e 24 Approval Laboratory Director SMC SVMC 6/12/2024 3.0 l l 0 Mark Williams Laboratory Director (WILL1050) Approval Laboratory Director SFMC WEC 6/10/2024 3.0 t r 12/1o 2/ 2 Jeffery Green MD (JTGREEN) Approval Laboratory Director SPEC RCH 6/10/2024 3.0 o n f Jack Wilson Laboratory Director SPEC RCH (JJWILSON) o Approval Laboratory Director MRMC 6/7/2024 n rren 3.0 c ta s U Cu CoraGabriela UramTuculescu Laboratory Director (URAM0000) Approval Laboratory Director SECC 6/7/2024 3.0 Angie DUONG Laboratory Director (ADUONG) Approval Owner Approval 6/7/2024 3.0 Curtis Pfohl Mgr Lab (95715) Approval New Lab Director Approval 3/8/2024 2.0 CoraGabriela UramTuculescu Laboratory Director (URAM0000)  Approval Lab Director 1/4/2024 2.0 Clifton Bridges Laboratory Director SMH RGH (CLBRIDGE) Approval Laboratory Director CEC 1/3/2024 2.0 Lindsey Matthews Laboratory Director (MATT0083) Approval Laboratory Director SPEC 12/18/2023 2.0 Jack Wilson Laboratory Director (JJWILSON) Approval Laboratory Director RCH 12/18/2023 2.0 Iris Martin Laboratory Director (MART0216) Laboratory Director SFMC Approval 12/11/2023 2.0 Jeffery Green MD (JTGREEN) WEC Approval Owner Approval 12/7/2023 2.0 Curtis Pfohl Mgr Lab (CPFOHL) Approval Laboratory Director SECC 12/7/2023 2.0 Laboratory Director SMC y Angie DUONG Laboratory Director (ADUONG) p M Approval SVMC 12/7/2023 2.0 o Mark Williams Laboratory Director (WILL1050) c :1 4 P Approval Laboratory Director MRMC 12/7/2023 2.0 d e 24 12 Approval Lab Director 7/18/2023 1.0 l l CoraGabriela UramTuculescu Laboratory Director (URAM0000) 0 Clifton Bridges Laboratory Director SMH RGH (CLBRIDGE) t r 12/1o 2/ 2 o n f o Approval Owner Approval 6/23/2023 1.0 n rrenc ta s U Cu Jeff Bush Mgr Lab (BUSH0026) Version History Version Status Type Date Added Date Effective Date Retired 3.0 Approved and Current Major revision 6/4/2024 6/28/2024 Indefinite 2.0 Retired Major revision 12/4/2023 1/4/2024 6/28/2024 1.0 Retired Initial version 6/23/2023 7/18/2023 1/4/2024  Bon Secours Mercy Health Richmond HealthPartners Laboratories RSV on Abbott ID Now Micro-Micro-0165 (Version 3.0) Approved and current. Effective starting 6/28/2024. Bon Secours HealthPartners Laboratories Richmond, Virginia Technical Section: Microbiology Procedure: Abbott ID Now RSV CLINICAL SIGNIFICANCE AND PRINCIPLE The ID NOW™ RSV assay performed on the ID NOW™ Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection of respiratory syncytial virus (RSV) viral RNA in direct nasopharyngeal swabs and nasopharyngeal swabs eluted in viral transport media from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the diagnosis of RSV in children select OK > Follow prompts on screen. 5. Once complete, document the following in QCE or Unity: Page 5 of 12 Uncontrolled copy printed by Leetta Bateman Lead MLS on 12/12/2024 12:14 PM (EST). Page 5 of 12  Bon Secours Mercy Health Richmond HealthPartners Laboratories RSV on Abbott ID Now Micro-Micro-0165 (Version 3.0) Approved and current. Effective starting 6/28/2024. Bon Secours HealthPartners Laboratories Richmond, Virginia Technical Section: Microbiology Procedure: Abbott ID Now RSV a. QC as Pass or Fail. b. Kit Lot Number and Expiration Date, in comment field. Internal QC The internal control has been designed to control for sample inhibition and assay reagent function. In positive samples where target amplification is strong, the internal control is ignored, and the target amplification serves as the ‘control’ to confirm that the clinical sample was not inhibitory, and that assay reagent performance was robust. At a very low frequency, clinical samples can contain inhibitors that may generate invalid results. Procedural Control Valid displayed on the instrument screen indicates that the assay reagent maintained its y p M o functional integrity and the sample did not significantly inhibit assay performance. The result is c :1 automatically stored in the instrument with each test result and can be reviewed by selecting4 Review Memory. If the internal control is not acceptable, test result will display as Invalid. P d e 24 12 MAINTENANCE 20 l l damage, contact Abbott Technical Support. 2 /1 / t r o Instrument is maintenance-free and has no serviceable parts.2In case of instrument failure or o f 1 o n Daily Maintenance t s n Wipe Exterior instrument and surfaces visible c a under the open lid. n ethanol, 70% isopropanol, 10% bleach. e o Acceptable cleaning agents:r70% U ur solution on instrument. o Do not Spray or Pour cleaning C o Do not disassemble instrument to clean. Wipe down work area and ensure it is free of debris and clutter. Page 6 of 12 Uncontrolled copy printed by Leetta Bateman Lead MLS on 12/12/2024 12:14 PM (EST). Page 6 of 12  Bon Secours Mercy Health Richmond HealthPartners Laboratories RSV on Abbott ID Now Micro-Micro-0165 (Version 3.0) Approved and current. Effective starting 6/28/2024. Bon Secours HealthPartners Laboratories Richmond, Virginia Technical Section: Microbiology Procedure: Abbott ID Now RSV TEST PROCEDURE (refer to IFU for further detail)  If reagent is stored in fridge, remove and allow to reach room temperature prior to testing.  Step by Step instructions will be presented on the screen. Do not move ahead of the on- screen instructions. Moving ahead or falling behind the on-screen instructions may result in an Invalid result. 1. Select Run Test > RSV > Select Sample Type > Enter Patient ID > Select  to confirm entry. a. Note: Instrument will prompt you to select Swab or Viral Transport Media. y p M o c :1 4 P d e 24 12 l l 0 i. t r 12/1o 2/ 2 on the screen > Select OK to proceed. o on f 2. Open instrument lid > Insert Orange Test Base > Confirm correct test (RSV) is displayed c ta s a. Important: Ensure reagent pellet is visible at bottom of reaction tubes prior to n rren inserting Test Base. If pellet not visible, discard and open new package. U Cu b. Do not touch the inside of Test Base or the Clear Reaction Tubes. c. If test not confirmed within 10 mins, instrument will time out and Test Base must be removed and discarded. Test must be restarted. d. If Test Base is dropped, discard and obtain a new one. 3. Insert Blue Sample Receiver into Receiver holder > Wait for Sample Receiver to Warm Up, a timer will appear on screen. a. Important: Do not remove Foil Seal until prompted by instrument. b. If test not confirmed within 10 mins, instrument will time out and Test Base must be removed and discarded. Test must be restarted. c. If Sample Receiver is dropped, discard and restart testing. 4. When prompted *Anchor Receiver with 2 fingers* and remove Foil Seal (without removing Receiver from holder) > Place patient sample into Sample Receiver. Page 7 of 12 Uncontrolled copy printed by Leetta Bateman Lead MLS on 12/12/2024 12:14 PM (EST). Page 7 of 12  Bon Secours Mercy Health Richmond HealthPartners Laboratories RSV on Abbott ID Now Micro-Micro-0165 (Version 3.0) Approved and current. Effective starting 6/28/2024. Bon Secours HealthPartners Laboratories Richmond, Virginia Technical Section: Microbiology Procedure: Abbott ID Now RSV a. Direct Nasopharyngeal Swab i. Insert and vigorously mix NP Swab in liquid for 10 seconds, being sure to press the swab head against the side of the Sample Receiver. Discard NP Swab. b. Nasopharyngeal Swab Eluted in Viral Transport Media i. Add 0.2 mL (200 µL) by using the provided disposable pipettes in the kit and vigorously mix the sample in liquid for 10 seconds. Discard pipette. c. Important: If Receiver is spilled when opening (prior to inserting the swab or dispensing VTM), clean instrument, discard Receiver and restart testing. If y p M Receiver is spilled after the swab has been inserted, discard Receiver and credit test (LABER) and ask for a new collection. 5. Once sample is mixed, immediately select OK to proceed. o c :1 4 P d 12 6. *Using 2 Hands* Press White Transfer Cartridge into the Blue Sample Receiver > Listen e 24 for Click > Push Cartridge completely down on Receiver until orange indicator has fully risen. l l0 a. t completely, to indicate enough sample has been 2r/ 1 o Important: Ensure orange indicator on White Transfer/ 2 Cartridge rises 2 transferred. If Cartridge fails to b. o n fill, discard all components and credit test1(LABER) and ask for a new collection. f If White Transfer Cartridge is dropped,odiscard and restart testing. n n ct as e c. UC ur r 7. Once Cartridge is filled > Lift then connect White Transfer Cartridge to Orange Test Base > Push Cartridge completely down on Test Base until orange indicator has fully descended. a. Important: Ensure orange indicator on White Transfer Cartridge fully descends, to indicate enough sample has been transferred. Failure to do so may potentially lead to invalid or false test results. If Cartridge fails to empty, discard all components and credit test (LABER) and ask for new collection. b. Page 8 of 12 Uncontrolled copy printed by Leetta Bateman Lead MLS on 12/12/2024 12:14 PM (EST). Page 8 of 12  Bon Secours Mercy Health Richmond HealthPartners Laboratories RSV on Abbott ID Now Micro-Micro-0165 (Version 3.0) Approved and current. Effective starting 6/28/2024. Bon Secours HealthPartners Laboratories Richmond, Virginia Technical Section: Microbiology Procedure: Abbott ID Now RSV 8. Once sample has been transferred, close lid and testing will begin. a. Important: Lid must be closed within 30 seconds, if not instrument will time out and all components must be removed and testing restarted. b. Do Not open lid during testing. Testing will be canceled and all components must be removed and testing restarted. Instrument will prompt user to open lid. 9. Once testing is completed, result will automatically print on the attached printer. a. Adhere the patient result printout to the worksheet. 10. Instrument will prompt user to Open Lid > Remove and Discard test components. 11. Removing test components: Lift White Transfer Cartridge, which has the Orange Test y p M Biohazard waste. o Base attached, and press into Blue Sample Receiver until a click is heard. Discard in c :1 a. Important: Do not remove the Sample Receiver by any other method as there is 4 P a risk of spilling the sample. d e 24 12 l l b. Important: Do not disassemble Transfer Cartridge and Test Base before disposal. 0 Home screen. t r 12/1o 2/ 2 12. Once removal complete > Close Lid > Instrument will run a Self-Test before showing 13. Enter patient result in LIS. o on f REPORTING RESULTS: c ta n rren s U Cu Reference Range: Negative for all Patients. Test Code: o Test Code: RSVNAB and Epic EAP: LAB10871 ▪ COVRS: Source, result with NP at time of receipt ▪ RSVNA: RSV test result Abbott ID Now Resulting o Enter results in LIS with function MEM with the worksheet in use at your facilty. SITE WORKSHEET SITE WORKSHEET SITE WORKSHEET CEC FCMAN SECC RHMAN SRM RRMAN MRMC MNOW SFMC FNOW SVR REMAN RCH CNOW SMH M4 WEC FWNOW RGH RNOW SPEC SPMAN Page 9 of 12 Uncontrolled copy printed by Leetta Bateman Lead MLS on 12/12/2024 12:14 PM (EST). Page 9 of 12  Bon Secours Mercy Health Richmond HealthPartners Laboratories RSV on Abbott ID Now Micro-Micro-0165 (Version 3.0) Approved and current. Effective starting 6/28/2024. Bon Secours HealthPartners Laboratories Richmond, Virginia Technical Section: Microbiology Procedure: Abbott ID Now RSV o At accept of modify prompt, enter M to Modify the Method code (METH) to the correct reporting instrument, if needed. ▪ Example: under the M4 worksheet the default Method code is SNOW2, if using SNOW3 this must be updated to SNOW3 o At the COVRS prompt, Enter: NP o At the RSVNA prompt, Enter Result as: DET, NOTD, or INDET (see table below) Instrument Result Reportable LIS Result y p M Positive Detected (DET) o c :1 4 P ACID d POSITIVE FOR THE PRESENCE OF RSV NUCLEIC e 24 12 l l 0 Methodology: Isothermal Nucleic Acid t r 12/1o Amplification Rapid Abbott ID Now 2/ 2 o n f **Intended for use in patients 59years of age** Not Detected (NOTD) U Cu NEGATIVE FOR THE PRESENCE OF RSV NUCLEIC ACID Negative results do not preclude infection with RSV and should not be used as the sole basis for patient management decisions. Methodology: Isothermal Nucleic Acid Amplification Rapid Abbott ID Now **Intended for use in patients 59years of age** Page 10 of 12 Uncontrolled copy printed by Leetta Bateman Lead MLS on 12/12/2024 12:14 PM (EST). Page 10 of 12  Bon Secours Mercy Health Richmond HealthPartners Laboratories RSV on Abbott ID Now Micro-Micro-0165 (Version 3.0) Approved and current. Effective starting 6/28/2024. Bon Secours HealthPartners Laboratories Richmond, Virginia Technical Section: Microbiology Procedure: Abbott ID Now RSV Instrument Result Reportable LIS Result Invalid Indeterminate (INDET) The presence or absence of RSV cannot be determined. If clinically indicated, please collect a new specimen. Methodology: Isothermal Nucleic Acid Amplification y p M Rapid Abbott ID Now o c :1 4 P d **Intended for use in patients 59years of age** l l 0 Notification of Results t r 12/1o 2/ 2 Critical Value: Detected (DET) o n f o Document notification call with -CLT (called to and read back by), o c ta s nurse name, credentials, time, and tech initials. Refer to Reporting n rren Critical Values procedure. LIMITATIONS OF THE PROCEDURE U Cu The performance of the ID NOW™ RSV was evaluated using the procedures provided in this package insert only. Modifications to these procedures may alter the performance of the test. ID NOW™ RSV performance depends on viral RNA load and may not correlate with cell culture performed on the same specimen. Viral nucleic acid may persist in vivo, independent of virus viability. Detection of analyte target(s) does not imply the corresponding virus(es) are infectious or are the causative agents for clinical symptoms. There is a risk of false negative results due to the presence of sequence variants in the viral targets of the assay. If the virus mutates in the target regions, RSV viruses may not be detected or may be detected less efficiently. Additionally, if the sequence variant Page 11 of 12 Uncontrolled copy printed by Leetta Bateman Lead MLS on 12/12/2024 12:14 PM (EST). Page 11 of 12  Bon Secours Mercy Health Richmond HealthPartners Laboratories RSV on Abbott ID Now Micro-Micro-0165 (Version 3.0) Approved and current. Effective starting 6/28/2024. Bon Secours HealthPartners Laboratories Richmond, Virginia Technical Section: Microbiology Procedure: Abbott ID Now RSV occurs in the target sequence recognized by the fluorescent-labeled molecular beacon an invalid assay may result. False negative results may occur if a specimen is improperly collected, transported or handled. False negative results may occur if inadequate levels of viruses are present in the specimen. Mucin may interfere with RSV detection at levels greater than 0.0625% w/v. This test is not intended to differentiate RSV subtypes. If differentiation of specific RSV subtypes is needed, additional testing, in consultation with state or local public health departments, is required. y p M Negative results do not preclude infection with RSV and should not be the sole basis of a patient treatment decision. o c :1 4 P This test has not been evaluated for patients without signs and symptoms of respiratory infection. d e 24 12 l l Cross-reactivity with respiratory tract organisms other than those tested in the 0 Analytical Specificity Study may lead to erroneous results. t r 12/1o This assay has not been evaluated for immunocompromised individuals. 2/ 2 organism present. o on f The test is a qualitative test and does not provide the quantitative value of detected c ta s Positive and negative predictive values are highly dependent on prevalence. The assay n rren performance was established during the 2015 to 2016 respiratory season. The positive U Cu and negative predictive values may vary depending on the prevalence and population tested. REFERENCES 1. World Health Organization (WHO) Acute Respiratory Infections (Update September 2009). [Online] Available from: http://apps.who.int/vaccine_research/diseases/ari/en/index2.html Accessed: 20 Nov 2015 2. Williams, KM, Jackson MA, Hamilton M. Rapid Diagnostic Testing for URIs in Children: Impact on Physician Decision Making and Cost. Infect. Med. 19(3): 109-111, 2002. Page 12 of 12 Uncontrolled copy printed by Leetta Bateman Lead MLS on 12/12/2024 12:14 PM (EST). Page 12 of 12