Document text
VACCINE RESEARCH TEST MET HOD PEA RL RI VER, NY
TITLE: Test Met hod for the SARS CoV-2 Nucleocap sid(N)
Antigen Dete ction AssayDoc. Number: VR-TM-10304 Version: 3.0
Doc. Alias: NA
PFIZER CONFIDENTI AL
Page1
TABLE OF CONTENTS
LIST OF TABLES ................................ ................................ ................................ ..................... 2
LIST OF FIGURES ................................ ................................ ................................ ................... 2
1.HISTORICAL REVI SIONSUMMARY ................................ ................................ .............. 4
2.PURPOSE ................................ ................................ ................................ .............................. 4
3.SCOPE ................................ ................................ ................................ ................................ ...4
4.GLOSSARY ................................ ................................ ................................ .......................... 4
5.GENERAL ................................ ................................ ................................ ............................. 5
6.RESPONSIBILIT IES................................ ................................ ................................ ............ 5
7.SAFETY ................................ ................................ ................................ ................................ 6
7.1. Equipment ................................ ................................ ................................ ................. 6
7.2.Materials ................................ ................................ ................................ .................... 7
7.3.Reagent Stocks ................................ ................................ ................................ .......... 7
7.4.Negative and Positive Calibrators ................................ ................................ ............. 7
7.5.Negative and Positive Quality Controls ................................ ................................ ....7
7.6.Buffers ................................ ................................ ................................ ....................... 8
8.WARNI NGS, PRE CAUTIONS AND NOTES ................................ ................................ .....8
8.1.Sample Entry in VRD LabWare LIMS and Batch Creation ................................ .....8
9.PROCEDURE ................................ ................................ ................................ ........................ 9
9.1.Obtaining S amples and Sample Entry in VRD L abWare LIMS ............................... 9
10. STARTUP PROCEDURE................................ ................................ ................................ .11
10.1. Running QCs ................................ ................................ ................................ ......... 11
10.2. Uploading into VRD LIMS L ABWARE ................................ .............................. 13
10.2.1. Addition of Standby Reagent Packs, when Needed ................................ .14
10.3. Testing of Patient Clinical Samples ................................ ................................ ......14
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FDA-CBER-2021-5683-0779619
VACCINE RESEARCH TEST MET HOD PEA RL RI VER, NY
TITLE: Test Met hod for the SARS CoV-2 Nucleocap sid(N)
Antigen Dete ction AssayDoc. Number: VR-TM-10304 Version: 3.0
Doc. Alias: NA
PFIZER CONFIDENTI AL
Page210.3.1. Primary Method – Automated Barcode Scan ................................ ........... 14
10.3.1.1. Misread Sample Barcodes ................................ ....................... 16
10.3.2. Secondary Method –Assignment of Sample Testing Using the
Handheld Barcode Scanner ................................ ................................ .............. 16
11.DATA EXPORT ................................ ................................ ................................ ................ 17
11.1. Data Export ................................ ................................ ................................ ........... 17
11.2. Transfer using a USB Flash Drive ................................ ................................ ........ 18
11.3. Transfer thr ough a USB Sharing Device ................................ ............................... 19
12.DOCUMENTATION ................................ ................................ ................................ ........ 20
13.ASSAY METADATA COMP LETION ................................ ................................ ............ 20
14.REPEAT PROCESS ................................ ................................ ................................ .......... 22
15.SHUTDOWN PROCEDURE ................................ ................................ ............................ 22
16.INTERPRETATION OF RESULT ................................ ................................ ................... 22
17.REFERENCES ................................ ................................ ................................ .................. 22
18.DOCUMENT VERSION MO DIFICATIONS ................................ ................................ ..23
18.1. CRIF Number: VR -CRIF-20 -14753 ................................ ................................ .....23
LIST OF TABLES
Table 1. Chronological Summary of Previous Versions ................................ .......... 4
Table 2. Vaccine Research Functional Units ................................ ............................ 4
Table 3. Terms and Definitions ................................ ................................ ................ 4
Table 4. Roles and Responsibili ties................................ ................................ .......... 5
Table 5. General Refer ences ................................ ................................ ................... 22
Table 6. Form References ................................ ................................ ....................... 23
Table 7. Specific References ................................ ................................ .................. 23
Table 8. Detailed Changes ................................ ................................ ...................... 23
LIST OF FIGURES
Figure 1. Interface ................................ ................................ ........ 9
Figure 2. Select a Function Window ................................ ................................ ........ 10
Figure 3. Move to Lab Room Window ................................ ................................ ....10
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FDA-CBER-2021-5683-0779620
VACCINE RESEARCH TEST MET HOD PEA RL RI VER, NY
TITLE: Test Met hod for the SARS CoV-2 Nucleocap sid(N)
Antigen Dete ction AssayDoc. Number: VR-TM-10304 Version: 3.0
Doc. Alias: NA
PFIZER CONFIDENTI AL
Page3Figure 4. QC Rack Exampl e ................................ ................................ .................... 11
Figure 5. System Overview................................ ................................ ...................... 12
Figure 6. Start Conditions Window ................................ ................................ ......... 12
Figure 7. Calibration Form Example Page................................ ............................... 13
Figure 8. Sample R ack with Inserts for Clinical Sample Tubes .............................. 15
Figure 9. Test Selection Screen ................................ ................................ ................ 15
Figure 10. Data Export Window ................................ ................................ ................ 18
Figure 11. USB Sharing Switch L ight I ndica tor................................ ........................ 19
Figure 12. USB Sharing Switch ................................ ................................ ................. 20
Figure 13. Move to Lab Freezer Window ................................ ................................ ..21
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FDA-CBER-2021-5683-0779621
VACCINE RESEARCH TEST MET HOD PEA RL RI VER, NY
TITLE: Test Met hod for the SARS CoV-2 Nucleocap sid(N)
Antigen Dete ction AssayDoc. Number: VR-TM-10304 Version: 3.0
Doc. Alias: NA
PFIZER CONFIDENTI AL
Page41.HISTORICAL REVIS ION SUMMARY
Table 1. C hronological Summary of Previous Versions
Version
#Effect iveDate Orig inator Summary
3.0 Current Updated Repeat process, added guidance for QCs
expir y dates , updated data export process t o include
use of aUSB Sharing Device .
2.0 25-Sep- 2020 Updated matierals and equipment, created sections in
procedure ,added figures , added primar ymethod of
running clinical samples, added procedure for use of
VRD Lab Ware L IMS, Re moved startup and
shutdown proce dure, added repeat process procedure,
added steps to the data export , added steps to the
skills assessment.
1.0 29-Jul-2020 New SOP
2. PURPOSE
This docu ment describes the proced ures used to perf ormthe Elecsy s anti SARS-CoV -2 assay
using the Roche Diagnostic cobas Immunoassay System.The Roche Diagnostic
cobas Immunoassay System is a fully automat ed, rando maccess, software -control led
system for immunoassay analysis.
3.SCOP E
Personnel in Vac cines Resear ch andDevelopment that perform reg ulated testing are required
to foll ow this SOP .
Table 2.Vaccine Resea rch Fu nctional Units
Functional Units Location
VRD (Va ccine Resea rch and Develop ment) Pearl Riv er
4.GLO SSAR Y
Table 3.Terms a nd Definiti ons
Term Definition
ACOV2 Ca l1 Nega tive cali brato r 1
ACOV2 Cal2 Positive calibrator 2
Coated Microspheres Streptavidin coated b eads at 0.72mg/m L
COVID ‑19 Coronavirus Disease 2019
Elecsys Anti ‑SARS ‑CoV‑2 A n immunoassay intended for qualitative detect ion of antibodies to SARS ‑CoV‑ 2
in human serum and plasma
LIMS Laboratory Information Management System
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FDA-CBER-2021-5683-0779622
VACCINE RESEARCH TEST MET HOD PEA RL RI VER, NY
TITLE: Test Met hod for the SARS CoV-2 Nucleocap sid(N)
Antigen Dete ction AssayDoc. Number: VR-TM-10304 Version: 3.0
Doc. Alias: NA
PFIZER CONFIDENTI AL
Page5Table 3.Terms a nd Definiti ons
Term Definition
mAb Monocl onal anti body (also known as captur e antibodi es)
QCS Qualit y Control Samples
Room Temperature (RT) Room temperat ure in this SOP is defined as 20 °C with a range of 18 -25°C.
SAR S-CoV-2 Severe Acute Respiratory Syndrom e Coronav irus 2
SM Sample Management
5.GENERAL
SARS -CoV-2 is an envelope d, single -strande d RNA virus of the famil y Co ronaviridae, gen us
Betacoronavir us. All coronavirus es share similarities in the organization and expression of
their genome, which encodes 16 nonstructural proteins and the 4 s tructural prote ins:
spike (S), env elope (E), membrane (M), and nucleocapsid (N). Theycause di sease with
symptoms ranging from those of a mild common cold to mo re severe on es such as the Severe
Acute Respirato ry Syndrome (SARS), Middle Ea st Respiratory Syndrome (MERS) a nd
Coronavirus Dise ase 2019 ( COVID -19).
Elecs ys Anti-S ARS -CoV -2 is an i mmunoass ay intended for qualitative detection of
antibodies to SARS -CoV -2 in huma n ser um and plasma (K2-EDTA, K 3-EDTA, L i-heparin).
The assay uses a recombinant protein r epresenting th e nucleocapsid (N) antigen fo r the
determination of an tibodies agai nst SARS -CoV -2. The test is intended for use as an aid i n
identify ing indi vidual s with an immune response to SARS -CoV -2which i ndicat es a recent or
prior inf ection. Antibo dies t o SARS -CoV -2are generall y detectable i n blood forseveral
days after theinitialinfec tion.
6.RESPONSIBILIT IES
All personnel and positi ons refe rred to in this procedure are conside red to have an
alternate.
An alternate must ensure that they are traine d and knowledge able with the process.
Table 4.Roles and Re sponsibiliti es
Role Respons ibilities
Laboratory Analy stPerforms the test method followin g the proced ures des cribed in this SOP .
Reads , understands, and completes training on VR -SOP-FE-11297 (SA 01).
Com pletes documen tation of the w ork perfor med and any deviations that occ urred .
Follows app licable departmental SOPs regarding safety, eq uipm ent u se and
documentati onpractices .
Initiates LDRs, if need ed.
Notifies supervisor of any atyp ical eve nts.
This person ca nnot be th e Data Reviewer for the s ame batch.
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FDA-CBER-2021-5683-0779623
VACCINE RESEARCH TEST MET HOD PEA RL RI VER, NY
TITLE: Test Met hod for the SARS CoV-2 Nucleocap sid(N)
Antigen Dete ction AssayDoc. Number: VR-TM-10304 Version: 3.0
Doc. Alias: NA
PFIZER CONFIDENTI AL
Page6Table 4.Roles and Re sponsibiliti es
Role Respons ibilities
Data Reviewer Reads, understand s, and completes training on VR -SOP-LC-11296 (SA01) .
Revie wsdocu mentation to ensure completeness of data entry an d compliance with
Pfizer policies. Directs t heLaboratory Analy st to corr ect documentation er rors.
This person cann ot be the Laboratory Analyst for the same batch .
Initiates LDRs, if need ed.
Supervisor Reviews and signs documentation.
Ensures that an alysts have bee n trained on appropriat e SOPs.
Ensures LDRs are init iated and p roperl y investigated .
Ensures that equipment and instruments have been properly calibrated and
maintained .
7.SAFE TY
Biosafet y lev el 2 precautions should be taken when handl ing hum an and non -huma n
biological fluids or materials asrecommended in the CDC/NIH manual , "Biosafet y in
Microbiolog ical and Biomedi cal Laboratories", 5thed., 2009:
http://www. cdc.gov/bio safety/publications/bmbl5/ .
Personnel must be trained on current laboratory safet y proce dures and made aware of the
Mater ial Safet y Data Sh eets for ch emicals being used, be fore perform ingthisprocedu re.
All laboratory work is to be carried out in complian cewith site safet y pol icies. Refer to
the Global Laboratory Safe ty Refe rence Manual:
http:// or the
Pearl RiverEnvi ronmental Health and Safet y Laborator y Manual :
http:// for safety precautions.
Lab coats, safet y glasse s and disposable gloves must be w orn at all times w hen handlin g
human specimens.
7.1.Equipm ent
Roche cobas anal yzer, , or equivalent.
Scientific freezers, -80°C ±15°C .
Scient ific refrigerator, 5°C (2°C to 8°C) .
Centrifuge, or equivalent .
Cappe r, .
Thawing Station, .
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FDA-CBER-2021-5683-0779624
VACCINE RESEARCH TEST MET HOD PEA RL RI VER, NY
TITLE: Test Met hod for the SARS CoV-2 Nucleocap sid(N)
Antigen Dete ction AssayDoc. Number: VR-TM-10304 Version: 3.0
Doc. Alias: NA
PFIZER CONFIDENTI AL
Page7 , or equival ent.
Computer .
Printer .
Peripheral Sharing Switch , , or equivalent.
7.2.Materials
11706802001, AssayCup, 60 x 60 reaction cups.
11706799001, Assay Tip, 30 x 120 pipette tips.
118005 07001, Clean ‑Liner.
Polypropy lene pipette tips, various sizes .
Sterile disposable serological pipettes, various sizes .
Biohazardous waste receptacle, bioha zardous sharps waste container .
7.3.Reagent Stocks
Elecs ysAnti- SARS -CoV -2 assay kit, Roche, Cat # 0920 309519 0.
Molecular Biology Grade Water, , or equivalent .
7.4. Negative and Positive Calibrators
ACOV2 Cal1 Negative cal ibrator 1 (white cap), 1 bottle of 0.67 mL: Human serum,
non-reactive for a nti-SARS -CoV -2 antibodies; buffer; prese rvative.
ACO V2Cal2 Positive calibrator 2 (black cap), 1 bottle of 0.67 mL: Human serum,
reactive for anti- SARS -CoV -2 antibodies; buffer; pre servative .
7.5.Negative and Positive Quality Controls
COV2 -Negative Serum .
COV2 -Positive Serum.
PreciControl Anti- SARS -COV -2(PCACOV2 1),Negative Control, 1 yellow bottle of
1.0 mL , Cat# 09216928190.
PreciControl Anti- SARS -COV -2 (PC ACOV2 2), Positive Control, 1brown bottle of 1.0
mL,Cat# 09216928190.
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VACCINE RESEARCH TEST MET HOD PEA RL RI VER, NY
TITLE: Test Met hod for the SARS CoV-2 Nucleocap sid(N)
Antigen Dete ction AssayDoc. Number: VR-TM-10304 Version: 3.0
Doc. Alias: NA
PFIZER CONFIDENTI AL
Page87.6.Buffers
11662988122, Procell, 6 x 380 mL system buffer.
11662970122, CleanC ell, 6 x 38 0 mL measuring cell cleaning solution.
11930346122, Elecs ys SysWash, 1 x 500 mL wash water additive .
11933159001, Adapter for Sy sClean .
1129850016 0, Elecs ysSysClean.
8.WARNINGS, PRECAUTIONS AND NOT ES
Ensure the samples, calibrators and controls are a tRT prior to measurement.
Roche c alibrators and controls should be analy zed/measured within 2 hours ofreaching
RT.
For all re agents pr ovided by Roche : Elecsys Anti-Sars-CoV-2 assay kit, PreciCo ntrol
Anti-SARS -CoV -2Negative , and Posi tive Control, follow vendor mandated expiration
dates .
Specimens should not be altered with additives ( eg,biocides, antioxidants or substan ces
that could possibly change the pH or ionic streng th ofthe sample) in order to avoid
erroneous findings.
Do not use samples and controls stabilized with azide.
8.1. S ample E ntry in VRD LabWare LIMSandBatch Creation
1.Obtain serumsamples (in a workbox) to be processed from SM. Log in to L abWare
LIMS and upda teworkbox location when applicable (ie,lab freezer, benchtop) .
2.If LIMS is unavailable, p rintout form VR-TM-1030 4-FM01 andVR-SOP-LC-10601 -
FM07(Chain of C ustody) torecord all app ropriate information during the sample
processing st eps.
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FDA-CBER-2021-5683-0779626
VACCINE RESEARCH TEST MET HOD PEA RL RI VER, NY
TITLE: Test Met hod for the SARS CoV-2 Nucleocap sid(N)
Antigen Dete ction AssayDoc. Number: VR-TM-10304 Version: 3.0
Doc. Alias: NA
PFIZER CONFIDENTI AL
Page99.PROCEDUR E
9.1.Obtaining Samples and S ample Ent ry inVRD L abWare LIMS
If LIMS is unavailable, pri ntout form VR -TM-10304 -FM01 and VR -SOP-LC-10601 -FM07
(Chain of Custody ) to record all app ropriate information during the sample processing steps.
1.Remove sample w orkbox from the freezer and log wor kbox move ment in LIM Susing the
following steps .
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FDA-CBER-2021-5683-0779627
VACCINE RESEARCH TEST MET HOD PEA RL RI VER, NY
TITLE: Test Met hod for the SARS CoV-2 Nucleocap sid(N)
Antigen Dete ction AssayDoc. Number: VR-TM-10304 Version: 3.0
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PFIZER CONFIDENTI AL
Page1011.Thaw samples in workbox using the thawing station.
12.Once completely thawed, place workbox on at 25 RPM for approximately
5minu tes to mix the sampl es.
13.Centrifuge entire workbox for 2 minutes at 3000 x g, max acceleration, max deceleration.
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VACCINE RESEARCH TEST MET HOD PEA RL RI VER, NY
TITLE: Test Met hod for the SARS CoV-2 Nucleocap sid(N)
Antigen Dete ction AssayDoc. Number: VR-TM-10304 Version: 3.0
Doc. Alias: NA
PFIZER CONFIDENTI AL
Page1110. S TARTUP PROCEDURE
Refer to VR -SOP-FE-1129 7, Operation and Maintenance of the Roche cobas anal yzer
for the Startup Procedure.
10.1. Runnin g QCs
1.Allow frozen QC vi als to warm to RT before loading.
2.Once QC samples are thawed and at RT, place negative QC in position 1 and positive QC
in position 2 of rack #0002 .Place Roche PC ACOV2 1 in position 3 and Roche PC
ACOV2 2 in position 4 of rack #0 002 (Figure 4). Rack #0002 is designated as a QC rack
insoftware.
Figure 4.QCRack Example
3. P ress START on right side of screen ( Figure 5) and STA RTon the START scree n
(Figure 6).
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FDA-CBER-2021-5683-0779629
VACCINE RESEARCH TEST MET HOD PEA RL RI VER, NY
TITLE: Test Met hod for the SARS CoV-2 Nucleocap sid(N)
Antigen Dete ction AssayDoc. Number: VR-TM-10304 Version: 3.0
Doc. Alias: NA
PFIZER CONFIDENTI AL
Page12Figure 5.System Overview
Figure 6.Start Conditions Window
4.Once the calibration and QC Sarecompleted, t he Roche cobas anal yzer will print
out a Calibration Form page (Figure 7) and a QCS Result page for each QC S.
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FDA-CBER-2021-5683-0779630
VACCINE RESEARCH TEST METHOD PEARL RIVER, NY
TITLE: Test Method for the SARS CoV-2 Nucleocapsid (N)
Antigen Detection AssayDoc. Number: VR-TM-10304 Version: 3.0
Doc. Alias: NA
PFIZER CONFIDENTIAL
Page 13Figure 7. Calibration Form Example Page
5.Confirm QCS results : negative controls are “n-reac” and positive controls are “reac.”
6. On the Calibration Form page and QC result pages, write the Asset number, initials, and
date (Figure 7).
7. Scan the Calibration Form and QCS Result pages as a pdf. Save the file name as
8. Save the Calibration Form pdf in th e appropriate secure shared drive: ie,
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FDA-CBER-2021-5683-0779631
VACCINE RESEARCH TEST MET HOD PEA RL RI VER, NY
TITLE: Test Met hod for the SARS CoV-2 Nucleocap sid(N)
Antigen Dete ction AssayDoc. Number: VR-TM-10304 Version: 3.0
Doc. Alias: NA
PFIZER CONFIDENTI AL
Page1410.2.1. A dditio n of S tandby Reagent Packs, when Needed
1.Remove reagent pack from 4°C storage and allow to come to room t emper ature
.
2.Open reagent pack t urntable and place new reagent pack into an open slot. A maximum
of 18 reagents packs can be pl aced i n theturntab le at one ti me.
3. Open the three reservoirs of the reagent pack and place the lids of eac h reservoir into a
soft open position. The caps should cover the pack opening but not be pushed to a fully
closed posi tion.
4.Calibrate all new p acks. To progra ma reagent calib ration, go to the Overview screen .
select Calibration >Status . Select all ACOV2 reagents listed in the table. Belo w
Method , select Full, and select Save .
5.Check on System Overview to confirm that the calibration was assi gned c orrectl y.
6. To run QC S on a standby p ack, go to QC>Status > Standby bottle QC>check box>
OK.Check on Syste m Overview (Figure 5) to see if processed correctl y.
7.Place tube (s) in sam ple rack, barcodes facing out. Press STA RT, and then START again
(Figure 6).
10.3. Testing of Patient Clini cal Samples
10.3.1. Primary Method –Autom ated Barcode Scan
The anal yzer can scan the tube barcodes prior to as signing th e tests to each of the sc anned
barcodes.
1. Pl ace barcoded sample s into the rack ( Figure 8)with the barcodes facing out .Do not use
racks #0001 or #0002 for clinical samples. There are 5 sample positions p er rack.
Fifteen racks can be loaded onto the machine at one time. Remo veall tube caps pr ior to
loading the racks into the anal yzer.
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VACCINE RESEARCH TEST MET HOD PEA RL RI VER, NY
TITLE: Test Met hod for the SARS CoV-2 Nucleocap sid(N)
Antigen Dete ction AssayDoc. Number: VR-TM-10304 Version: 3.0
Doc. Alias: NA
PFIZER CONFIDENTI AL
Page15Figure 8.SampleRack with Inserts for Cl inica l Sample Tubes
2.Load the racks into the loading tr ay and tra nsfer the loading tray onto the A-Line track of
the rack sa mple r.
3.From the System Overvi ewscreen ( Figure 5), select the Start button. Rack and tube
barco des will be scanned by the anal yzer. Once complet ed, the sa mple racks will be in
theC-Line track of the r ack sample r.
4.Selec t Workplace > Test Select ion (Figure 9).
Figure 9. Test Selection Screen
5.Select Previous repeatedly until the rack, position, and barcode for the first sample is
display ed in the Rack No, Po s, and Samp le ID fie lds.
6.Selec t ACOV 2to assign the SARS -CoV -2 N immunoassay testing to each sample
barcode and Save .Sample I DField
Rack Number and
Position
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VACCINE RESEARCH TEST MET HOD PEA RL RI VER, NY
TITLE: Test Met hod for the SARS CoV-2 Nucleocap sid(N)
Antigen Dete ction AssayDoc. Number: VR-TM-10304 Version: 3.0
Doc. Alias: NA
PFIZER CONFIDENTI AL
Page167.Repeat S tep6 for all remaining samp les.
8.Swap the load ing tray s between the C-Line track and A-Line track of the rack sampler.
Thesample racks do not need to be rearra nged.
9.Select the Start button to begin the assay run (Figure 5) and St arton the Start screen
(Figure 6).
If any sample barcodes were misread during the assay run,no results will be genera ted.
Do NOT repeat. A repeat will be generated by the associated data review er.
IMPORTANT: Barcode(s) fr om an y unprocesse d samples mu st be recorded in a Batch
Comment in LIMS.
10.3.1.1. Misread Sample Barcodes
Ifany sample b arcodes were missed or incorr ect,a seq uence can be generated to add the
sample barcode and test before starting the run.
1.From the System Overvi ew sc reen , select the Workplac e tab (Figure 5).
2.From the Workplace scre en, select Test Sel ection.
3. S can the sa mple barcode in the Sample I D field ( Figure 9).
4. Sel ect the ACOV 2test under the Sam pleStatus and select Save
5.Repeat ste ps 1-4 for all remaining samples.
6.Select the Start button (Figure 5) and Starton the Start screen ( Figure 6) to begin th e
run.
If any sample barcode swere misread during theassay run, no results will be generated.
Do NOT repea t. A repeat will be generated by the ass ociated data reviewer .
IMPORTAN T: Barcode(s) from an y unprocessed samples must be recorded in a Batch
Comme nt in LIMS.
10.3.2. Secondary Metho d –Assignment of Sample Testing Using the Handheld
Barcode Scanner
The tubes can be placed within the racks prior to sca nning. The positions of the tube s with in
the racks and the order of the rac ks is not important as the anal yzer will cross match the
scanned tube barcodes with the requested sample barcodes, as outlined below. If a tube
barcode is scanned twice, it will o nly be tested once. If a tube barc ode is not scanned, the
tube will neither be tested nor flagged as an error during the barcode scann ing.
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FDA-CBER-2021-5683-0779634
VACCINE RESEARCH TEST MET HOD PEA RL RI VER, NY
TITLE: Test Met hod for the SARS CoV-2 Nucleocap sid(N)
Antigen Dete ction AssayDoc. Number: VR-TM-10304 Version: 3.0
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PFIZER CONFIDENTI AL
Page171.Selec t Workplace > T est Selection (Figure 9).
2.Select New Sequence (ensuring Rout ine(N) is selected ).
3.Select Sample I Dfield and scan the tube barcode using the handheld barcode scanner.
4.Select ACOV 2to assign t he SARS -CoV- 2 N immunoass ay testing.
5.Select Save .
6.Repeat steps 3-5 for all remaining samples.
7.Load the racks into the load ing tray and t ransfer the loading tray to the A -Line of the rack
sampler. Remove all tube caps prior to loadi ng the rack s into the an alyzer.
8.Select the Start button (Figure 5)and Starton the Start screen (Figure 6) to begi n the
run.
If any sample barcodes were misread during the assay run, n o res ults wil l be generated.
Do NOT r epeat. A repeat will be generated by the associated data reviewer .
IMPORTANT: Barcode(s) from an y unproc essed s ample s must be rec orded in a Batch
Comment in LIMS.
11.DATA EXPORT
11.1. Data Export
Data can be transferred eithe r through a US B flash drive or a USB Sh aring device. The data
can onl y be exported when the anal yzer is in Stan d-bymode. If the system i s not i n
Oper ation ,touch the global Stop button. Please note that selecting Stop during sampl e
testing will abort t he run.
If usi ng a USB Sharing De vice, ensure that the USB Sharing Device light indicat or is set to
Roche.
1.Once the anal yzer is in Stand -bymode, touch System Overview > Workplace > Data
Review .
2. Select all the test re sults to export. SelectExport Data .Ensure t he Withbutton i s
selected for Double quotation marks in the Export D atawindow ( Figure 10).
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Page18Figure 10.Data Export Window
3.As the data is being exported , the St and-bymode will cha nge to Media Wri teand re turn
to Stand -byonce completed. Never remove the USB key from the an alyzer, unless it is
in the Stand -bymode as this can dama ge the unit.
4.Select the Remove USB global button. Select OKwhen the confirmation window
display s Do y ou wan t to rem ove the USB drive?
If the Roche cobas analyzer is connect ed to a USB device , proceed to Section 11.2.
If the Roche cobas anal yzer is connected to a USB Sharing Devic e, proceed to
Section 11.3.
11.2. Trans fer using a USB Flash Drive
1.Once the Please remov e the USB device from the system message appears, remove the
USB flash drive from the USB port at the le ft side of the anal yzer.
2. Insert the USB device onto the Roche cobas ass ociated laptop .
3.Log onto the R oche cobas associate d lapto p and naviga te to the USB drive
csv’s folder .
4.Ensure the correct numbe r of data ent ries are present on the cs v file .
5. T he file name i s exported onto the USB device as backup- yyyy -mm-dd, wher e
yyyy-mm-dd represents the date thedata was exported. Tran sferthe data fileinto the
folder .
6.Rename the file as t he batch name , ie, .
7.Copy a
nd paste the data file into the appropriate network drive.
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Page1911.3. Transfer through a US B Sharing Device
1.Once the Please remov e the USB device from the system message appears , use the
switch(Figure 12) to changethe output of the USB device from Roche to Laptop
(Figure 11).
2.Ensure the USB Sharing Switch Light Indicat or is changed to Laptop ( Figure 11).
3.Plug in the USB data tra nsfer cable into the Roche cobas associated laptop .
4.Log onto the R oche cobas associat ed lapto p and naviga te to the USB drive
csv’s folder .
5.Ensure the correct number of data ent ries are present on the cs v file .
6.The file name is exported onto the USB device as backup -yyyy -mm-dd, where
yyyy-mm-dd represents the date thedata was exporte d.Tran sferthe data fileinto the
folder .
7.Rename the file as t he batch name , ie, .
8.Copy a
nd paste the data file into the appropriate network drive.
Figure 11.USB Sharing Swit chLight Indicator
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Page20Figure 12.USB Sharing Switch
12. D OCUMENTATION
1.Raw data .csv fil es will be transferr ed to the secure network dri veupon assay completion.
Any other file t ypes do not need to be transfer red. Raw data is not require d to be printed.
13.ASSAY METADATA COMPLETION
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Page2214.REPEAT PROCESS
If a s ample ba rcode is not successful lyscanned by the Roche Cobas analy zer or an
error occurs du ring th e assay run, the sample will not be processed by the instrument. A
repeattest is then generated for the misread sample barcode by the assay run’s associated
data review er.
When assign ed a repeat batch, follow thesteps below:
1. R emove workboxes associated with the rep eat batc h and track sample movement of
workboxes from the fre ezer to the lab following Section 9.1.
2.Cher ry-pick the repeat sampl es needed from each workbox.
3.Scan sam plebarcode sand assign tests following Section 10.3.1.1 .
4. E nter r ack and position of each sample (Figure 9).
5.Onceall samples ha ve been e ntered, se lect the Start button (Figure 5) and Starton the
Start screen ( Figure 6)to begi n the run.
6.Once the samples complete processing, place the samples in totheir origi nal workbox.
7.Enter all assay metadata f ollowing Section 13.
8.Track m ovement of samples back into the freezer f ollowing Section 13.
15. S HUTDOWN PR OCEDURE
Please refer to V R-SOP-FE-11297, Operation and Maintenance of Roche cobas
analyzer for the Shutdown procedure . Replace the USB de vice into the analy zer
16. IN TERPRETAT ION OF RESULT
A qualified d ata reviewer analyzes the data accord ing to pre -specified accept ance c riteri a, as
describe d in VR- SOP-LC-11296 .
17.REFERENCES
Table 5.Gene ralReferences
Document Title
VR-SOP-LC-10586 Liquid Handlin g Techn iques for Regulated Laboratory Procedures .
VR-SOP-LC-10601 Data Package Chain o f Custo dy.
VR-SOP-QU-10004 Documentation Practices in Vaccine Research.
VR-SOP-LC-10774 Specimen Management Record Using Labware LIMS.
VR-SOP-QU-10726 Laboratory Devi ation R eport
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TITLE: Test Met hod for the SARS CoV-2 Nucleocap sid(N)
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Page23Table 6. F orm References
Form Title
VR-TM-1030 4-FM01 Assay Completion Wo rksheet for the SARS CoV -2 Nucleocapsid (N) antigen
Detection Assay
VR-SOP-LC-1060 1-FM07 Generic Assay Data Package Chain of Custody
Table 7.Specific References
Docu ment Title
VR-SOP-LC- 11296 Data Review for SA RS Co V-2 Nucleocap sid Antigen Detection Assay
VR-SOP-FE-11297 Operation of the Roche cobas Imm unoassay Analyzer
18.DOCUMENT VERSION MOD IFICATIONS
18.1. CRIF Numbe r: VR -CRIF -20-14 753
Table 8. D etailed Changes
List det ailed cha nges for document(s)
Include Section number(s) for eachList rationale for each change
Added Section 11.2 and Section 11.3. To reflect current p ractices .
Updated Section 8 to incl ude guidance for expiry
date for reagents .Clarity .
Updated Repeat P rocess for samples . To reflect current practices.
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