125742 S1 M5 5314 vr tm 10293

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VACCINE RESEA RCH TEST METHOD PEA RL RIVER, NY 
TITLE: Single -plex Luminex Assay for Qu antitation of 
IgGAntibodi es toSARS -CoV-2 S 1 Protein in Human 
SerumDoc Number: VR-TM-10293 Version: 1.0
Doc. Alias: NA
PFIZER CO NFIDENTIAL
Page 1
TABLE OF CONTENTS
LIST OF TABLES ................................ ................................ ................................ ..................... 2
LIST OF FIGURES ................................ ................................ ................................ ................... 2
1.HISTORICAL REVI SIONSUMMARY ................................ ................................ .............. 3
2.PURPOSE ................................ ................................ ................................ .............................. 3
3.SCOPE ................................ ................................ ................................ ................................ ...3
4.GLOSSARY ................................ ................................ ................................ .......................... 3
5.GENERAL ................................ ................................ ................................ ............................. 4
6.RESPONSIBILIT IES................................ ................................ ................................ ............ 4
7.SAFETY ................................ ................................ ................................ ................................ 5
8.MATERIAL S/EQUIPMENT ................................ ................................ ................................ 5
8.1. Equipment ................................ ................................ ................................ ................. 5
8.2.Materials ................................ ................................ ................................ .................... 6
8.3.Reag ents................................ ................................ ................................ .................... 7
8.3.1. Standard and QCS, Prepared as Described in VR -RGR -RS-10747............. 7
8.3.2. Microspheres ................................ ................................ ................................ .7
8.3.3. Secondary  Antibody ................................ ................................ ..................... 7
8.3.4. ................................ ................................ ................................ ............... 7
8.3.5. Buffers ................................ ................................ ................................ .......... 7
9.PROCEDURE ................................ ................................ ................................ ........................ 8
9.1.Preparation of Single -plex S1 Microspheres ................................ ............................. 9
9.2.Preparation of Sample Dilution Plates ................................ ................................ ......9
9.2.1. Robotic Preparation of Dilution Plates ................................ ......................... 9
9.2.2. Manual Preparation of Dilution Plates ................................ ....................... 10
9.2.2.1. Reference Standard ................................ ................................ ...10
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FDA-CBER-2021-5683-0779550
VACCINE RESEA RCH TEST METHOD PEA RL RIVER, NY 
TITLE: Single -plex Luminex Assay for Qu antitation of 
IgGAntibodi es toSARS -CoV-2 S 1 Protein in Human 
SerumDoc Number: VR-TM-10293 Version: 1.0
Doc. Alias: NA
PFIZER CO NFIDENTIAL
Page 29.2.2.2. Unknown Specimen and QCS................................ ................... 11
9.2.2.3. Samples Requiring Pre -dilutions ................................ ............... 11
9.2.2.4. Dilution Plate Completion ................................ ......................... 12
9.3.Preparation of Assay Plates ................................ ................................ ..................... 12
9.3.1. Robotic Preparation of Assay  Plates................................ ........................... 12
9.3.2. Manual Preparation of Assay  Plates ................................ ........................... 12
9.4.Primary  Incubation of S1 Coated M icrospheres with Sera ................................ .....12
9.5.Preparation of  Plate Washer ................................ ................................ ......... 13
9.6.PE-conjugated Secondary  Antibody  Preparation and Incubation ........................... 13
9.7.Assay  Completion ................................ ................................ ................................ ...14
9.8.Reading Assay  Plates on the Bio -Plex  I nstrument ................................ ........... 14
9.9.Rereading of Assay  Plates Due to Errors ................................ ................................ 15
9.10. Electronic Documentation ................................ ................................ ..................... 15
9.11. Data Export and Primary  Data Review ................................ ................................ .16
10.INTERPRETATION OF R ESULTS ................................ ................................ ................. 16
11.REFERENCES ................................ ................................ ................................ .................. 17
12.DOCUMENT V ERSION MODIFICATIONS ................................ ................................ ..18
12.1. CRIF Number: VR -CRIF-20 -14611 ................................ ................................ .....18
LIST OF TABLES
Table 1. Chronological Summary  of Previous Versions ................................ .......... 3
Table 2. Vaccine Research Functional Units ................................ ............................ 3
Table 3. Terms and Definitions ................................ ................................ ................ 3
Table 4. Roles and Responsibilities................................ ................................ .......... 5
Table 5. General References ................................ ................................ ................... 17
Table 6. Form References ................................ ................................ ....................... 17
Table 7. Specific References ................................ ................................ .................. 17
Table 8. Detailed Changes ................................ ................................ ...................... 18
LIST OF FI GURES
Figure 1. Dilution Plate Diagram ................................ ................................ ............. 10
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FDA-CBER-2021-5683-0779551
VACCINE RESEA RCH TEST METHOD PEA RL RIVER, NY 
TITLE: Single -plex Luminex Assay for Qu antitation of 
IgGAntibodi es toSARS -CoV-2 S 1 Protein in Human 
SerumDoc Number: VR-TM-10293 Version: 1.0
Doc. Alias: NA
PFIZER CO NFIDENTIAL
Page 31.HISTORICAL REVISION SUMMARY
Table 1.Chronological Summary of Previous Ve rsions
Versio n 
#Effective Date Originator Summary
1.0 Current Guy Singh New  Document
2. PURPOSE
This p rocedure descri bes the method to quantitate Ig Gantibody  levels to subunit 1 ( S1) of 
the spike (S) protein of severe acute respirator y disease coro navir us 2 ( SAR S-CoV-2).  The 
assay  method measures IgGantibody  levels for the S1protein in human serum.
3.SCOPE
Personnel in Vacci ne Research & Developme nt (VRD) that perform the s ingle-plex 
SARS -CoV -2 S1 IgGdLIAin regulated testing are required to follow this test method .
Table 2.Vacci ne Research Functio nal Units
Functional Units Location
Vaccine Re search & Development Pearl River
4.GLOSSARY
Table 3.Terms and Definitions
Term Definition
Ag Antigen
Assay Plate The 96 -well flat -bottom opaque plate us ed to per form the as say.
Batch
Beads A term interchangeable with microspheres .
COV19 Coronavirus Di sease 2 019
Dilution Plate,  
dLIA Direct Luminex Immunoassay
Expira tion Date Expirat ion dates of r eagents will be assign ed based on the av ailable s tability data.   
Specific expi ration dates may be recorded on reagen t labels, or within lab oratory 
notebooks or documentation workboo ks refere nced by the reagent label.
IgG Imm unoglobulin G
Labware LIMS TheLabw are brand of a Lab oratory Information Management System whic h is a 
database used to track specimens and their associated tests.
LNB Laboratory Notebook
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FDA-CBER-2021-5683-0779552
VACCINE RESEA RCH TEST METHOD PEA RL RIVER, NY 
TITLE: Single -plex Luminex Assay for Qu antitation of 
IgGAntibodi es toSARS -CoV-2 S 1 Protein in Human 
SerumDoc Number: VR-TM-10293 Version: 1.0
Doc. Alias: NA
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Page 4Table 3.Terms and Definitions
Term Definition
Metadata Assay -relatedinformation th at is captured in LabWare LIM S. This i ncludes
information per taining to reagents, equipment and instrum ents used to complete the
assay.
MFI Median Fluorescent Intensity
QCS Quality Control Sample
QNS Quantity Not Sufficient.  The designation given w hen a specimen has insufficient
volume to complete testing.
RT Room temperature defined as the ra nge from 18 to 25 °C
S Spike glycoprotein of s evere acute respirator y disease coronavirus 2
S1 Subunit 1 of theSpike protein
SAR S-CoV -2 Severe acute respirator y disease c oronavirus 2
VR-DWB Vaccine Research Document Workbook
WS Working Stock 
5.GENERAL
Thesingle -plex SARS -CoV -2 S1 IgGdLIAmeasur esSARS -Cov-2 S1 specific IgG
antibodies present in human serum sam ples.This assay isbased on the Luminex MagPlex ®
xMAP ®technol ogy platfo rm.  MagPlex ®microspheres are superparamagnetic carbox ylated 
xMAP microsphere sand allow assay  multiplexing and automation.   The S1 protein is 
 and attached to  coa ted microsphe res (VR-SOP-LC-11295).
S1coated microsphe res  are added to the assay  plates wi th 
appropr iately diluted refe rence standard serum, QCSand unknown serum samples.  
Theassay plates are incubated for hours at °C with shaking .  After w ashing of 
non-bound components , anti-human IgGsecondary  antibody  is added 
to the microsphere mixture and incubated for  mi nutesat RT .  The fluorescent protein
coupled to the secondary  antibody  allows for measurement of the antibody  bound to the 
antigen coated microsphe res by the Bio- Plex reader. Signals are expressed as median 
fluoresc ent inten sities (MF Is) and read against a reference standard .  The magnitude of the 
fluorescent  signal is proportional to the amount o f Ag-specific antibodies present in the 
sample.
6.RESPONSIBILITIES
All personnel and positions referred to in this proced ure are c onsidered to have an 
alternate .
An alternate must ensure that they  are trained and knowledgeable with the process.
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FDA-CBER-2021-5683-0779553
VACCINE RESEA RCH TEST METHOD PEA RL RIVER, NY 
TITLE: Single -plex Luminex Assay for Qu antitation of 
IgGAntibodi es toSARS -CoV-2 S 1 Protein in Human 
SerumDoc Number: VR-TM-10293 Version: 1.0
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Page 5Table 4.Roles and Responsi bilities
Role Responsibilities
Analyst Performs the test method foll owing the p rocedures described in this SOP.
Com pletesdocumentation of the w ork perform ed and any deviations that occurred .
Follows applicable depar tmen tal SOPs regarding safety, equipme nt use and 
documentation practices .
Initiates LDRs .
Notifies superviso r of any at ypical ev ents.
Supervisor or 
designeeReviews and signs documentation. 
Ensures that analysts have been trained on appropriate SOPs.
Ensures that equ ipment and instruments ha ve been prop erly calibrated and maintained.
Ensures LDRs are initiated and proper ly invest igated .
7.SAFETY
Biosafet y lev el 2 precautions should be taken when handling human sera. For current 
guidelines refer to the CD C/NI H Biosafe ty in Microbiological and Biomedical 
Laboratories Manual (BMBL), 5th Ed., 2009: 
http://www.cdc.gov/biosafe ty/public ations/bmb l5/index.htm.
Personnel must be trained on current labora torysafet y procedures and made aware of the 
Safety  Data Shee ts (SDS) for chemicals being used, bef ore performi ngthis procedure. 
For SDS information, refer to link at http:/
All laboratory  work is to be carried ou t incompliance with Pfizer safet y policies.  For 
general lab oratory safet y guidelines consult the Pearl River Environmental Health and 
Safety  Laboratory  Manual located at: 
http://
Lab coats, safet yglasses and disposable gloves must be worn at all times when handling 
human specimens .
8.MATERIALS/E QUIPMENT
Allequipment and materials used in regulated testing must co nform to cu rrent dep artmental 
guidelines for calib ration, maintenance and qualification.
8.1.Equipment
Bio-Plex Reader, Bio -Rad Cat. #  orequivalent
Platform Shaker, or equivale nt
Scientific freezers, -80°C ±15°C and -20°C -15/+5 °C
Scientific ref rigerator ,2 to 8°C
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FDA-CBER-2021-5683-0779554
VACCINE RESEA RCH TEST METHOD PEA RL RIVER, NY 
TITLE: Single -plex Luminex Assay for Qu antitation of 
IgGAntibodi es toSARS -CoV-2 S 1 Protein in Human 
SerumDoc Number: VR-TM-10293 Version: 1.0
Doc. Alias: NA
PFIZER CO NFIDENTIAL
Page 6 (magnetic bead) plate washer or equiva lent
Alarm timer
Single channel pipettes, various sizes
Multi -channel pipe ttes, manual and electronic, various si zes
  Pipetting Device,  or equivalent
Vortex m ixer
Nutat ing m ixer
8.2.Materials


96-well flat bottom opaque white plates,  or equ ivalent
Polypropylene pipette tips, various sizes 
Sterile disposable serological plastic p ipettes, various sizes
Dispos able polypropy lene tubes or container s, various sizes
Disposable light protective amber pol yprop ylene centrifug e tubes or containers, va rious 
sizes
Aluminum sealing tape for 96 well plates
Reagent Reservoir s, various sizes
Polypropy lene micro snap cap tube s
Tube racks
Magnetic separators
Bioh azardous waste receptacle
Biohazard sharps waste containers
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FDA-CBER-2021-5683-0779555
VACCINE RESEA RCH TEST METHOD PEA RL RIVER, NY 
TITLE: Single -plex Luminex Assay for Qu antitation of 
IgGAntibodi es toSARS -CoV-2 S 1 Protein in Human 
SerumDoc Number: VR-TM-10293 Version: 1.0
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Page 78.3. R eage nts
8.3.1. Stand ardand QCS , Prepared as D escribed in VR-RGR- RS-10747
Standard reference serum: COVI D19 IgGSTD
QCS
QC1: COVI D19 IgGQC1 
QC2: COVI D19 IgGQC2
QC3: COVI D19 IgGQC3
8.3.2. Microsp heres
Preparation of antigencoated microspheres is described in VR -SOP-LC-11295.Coated 
microspheres are  
8.3.3. Secondary Antibody
  anti- human IgG, (storeat 
2to 8°C).
8.3.4.

8.3.5. Buffers
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FDA-CBER-2021-5683-0779556
VACCINE RESEA RCH TEST METHOD PEA RL RIVER, NY 
TITLE: Single -plex Luminex Assay for Qu antitation of 
IgGAntibodi es toSARS -CoV-2 S 1 Protein in Human 
SerumDoc Number: VR-TM-10293 Version: 1.0
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Page 89.PROCEDURE
  
secondary  antibo dies are added to the plat es,incuba ted as described below and 
plates are read on Bio -Plex instruments.
Any step of this procedure may be performed manually , or b y a qualified automated 
method.  Follow VR-SOP-LC-11186for th e automated serum sample prepa ration by  a 
 robo tic unit.
Incubat or temperatures stated in this method are temperature r anges as f ollows: 
5°C = 2 -8°C; room temperature = 18 -25°C.
Bring all re agents and supplies to room temperat ure before use in all of the following 
steps. All assay steps ar e to be performed atroom tem perature unless otherwise 
specified.
Movement of specim ens from a nd back to cold storage is logged using LIMS following 
VR-SOP-LC-10774 .  For batches i n LIMS the reagent, equipment and incubation 
information will be captured as metadat a in LIMS . Raw data w ill be uploaded to LIMS.
VR-TM-10293-FM01 is the assay  comple tion worksheet used when sample prep aration
is performed either manu ally or by automated m ethods.  Anassay  completion worksheet 
is not required for fully  electronic/ paperless batches where metadata is recorded in LIMS
by a robotic unit or manually .
VR-TM-102 93-FM02 is the worksheet used to prepare sample dilution plate s manually .  
An assay  compl etion worksheet is not required for fully  electronic/paperless ba tches 
where metad atais recor ded in LIMS.
Refer to VR -SOP-LC- 10601 for instruction on m aintaining the documentation of the data 
package for paper -based docume ntatio n, if required. A Chain of Custody  form is not 
required for full y electronic/paperless batches where a ll meta data and ra wdata is 
recorded in/uploade d to LIMS .
Raw data CSV files will be t ransferred to the appropriate secure network drive upon 
assay comple tion.  An y other file t ypes do not need to be transferred, and raw data is not 
required to be printed. 
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FDA-CBER-2021-5683-0779557
VACCINE RESEA RCH TEST METHOD PEA RL RIVER, NY 
TITLE: Single -plex Luminex Assay for Qu antitation of 
IgGAntibodi es toSARS -CoV-2 S 1 Protein in Human 
SerumDoc Number: VR-TM-10293 Version: 1.0
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Page 99.1. P repa ration of Single-plex S1 Microspher es
The prepara tion ofS1 antig en coated microspheres is described in VR -SOP-LC-11295.   
9.2. P reparatio n of Sample Dilution Plate s
In the single -plex SARS -CoV -2 S1 IgGdLIA, each assay  plate is derived from a 
corresponding dilution plate.  Each dilution plate contains three QCS, serial ly-dilute d 
reference standard serum, blank and up to  test samples.  For ini tial testing, the  
dilutions of test sera are .  Additional dilutions can be evaluated if 
needed.   A dilution diagram of the plate is in Figure 1.
9.2.1. Robotic Preparation of Dilution Plates
Refer to VR -SOP- LC-11186 for sample and dilution plate preparation using the  
 robot. 
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FDA-CBER-2021-5683-0779558
VACCINE RESEA RCH TEST METHOD PEA RL RIVER, NY 
TITLE: Single -plex Luminex Assay for Qu antitation of 
IgGAntibodi es toSARS -CoV-2 S 1 Protein in Human 
SerumDoc Number: VR-TM-10293 Version: 1.0
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Page 109.2.2. Manual Preparation of Dilution Plates
4.See Figure 1for the Dilution Plat e Diagram.
Figure 1. Dilution Plate Diagram
9.2.2.1. Reference Standard 
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FDA-CBER-2021-5683-0779559
VACCINE RESEA RCH TEST METHOD PEA RL RIVER, NY 
TITLE: Single -plex Luminex Assay for Qu antitation of 
IgGAntibodi es toSARS -CoV-2 S 1 Protein in Human 
SerumDoc Number: VR-TM-10293 Version: 1.0
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Page 119.2.2.2. Unknown S pecim enand QCS
9.2.2.3. Samples Requ iring Pre- dilutions
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FDA-CBER-2021-5683-0779560
VACCINE RESEA RCH TEST METHOD PEA RL RIVER, NY 
TITLE: Single -plex Luminex Assay for Qu antitation of 
IgGAntibodi es toSARS -CoV-2 S 1 Protein in Human 
SerumDoc Number: VR-TM-10293 Version: 1.0
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Page 129.2.2.4. Dilution Plate Completion
9.3.Preparation of Assa y Plates
9.3.1. Robotic Preparat ion of Assay Plates
Refer to VR-SOP-LC-11186for assay plate p reparation using the  
Robot.  Continue to Section 9.4to begin a ssay comp letion steps.
9.3.2. Manual P reparation of Assay Plat es
9.4.Primary Incubation of S1Coat ed Microspheres with Sera
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FDA-CBER-2021-5683-0779561
VACCINE RESEA RCH TEST METHOD PEA RL RIVER, NY 
TITLE: Single -plex Luminex Assay for Qu antitation of 
IgGAntibodi es toSARS -CoV-2 S 1 Protein in Human 
SerumDoc Number: VR-TM-10293 Version: 1.0
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Page 139.5. Preparation of  PlateWashe r
1.Prepare  plate washer for use as described in VR -SOP-FE-10887.  Record the 
activit ies, as required, in the appropriate equipment logbook .
2.Ensure the Magnetic Bead Plate Adapto r is inserted for mag netic bead plate wash.
9.6.PE-conjugated Se conda ry Antibo dy Preparatio n and Incubation
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FDA-CBER-2021-5683-0779562
VACCINE RESEA RCH TEST METHOD PEA RL RIVER, NY 
TITLE: Single -plex Luminex Assay for Qu antitation of 
IgGAntibodi es toSARS -CoV-2 S 1 Protein in Human 
SerumDoc Number: VR-TM-10293 Version: 1.0
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Page 149.7.Assay Completion
9.8.Reading Assay Plat es on the Bio- Plex  Instrument
1.Prepare the Bio-P lex reader for use as described in VR -SOP-FE-10111.  Rec ord the 
activities, as required in the appropri ate equipment logbook.
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FDA-CBER-2021-5683-0779563
VACCINE RESEA RCH TEST METHOD PEA RL RIVER, NY 
TITLE: Single -plex Luminex Assay for Qu antitation of 
IgGAntibodi es toSARS -CoV-2 S 1 Protein in Human 
SerumDoc Number: VR-TM-10293 Version: 1.0
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Page 159.9. Rereading of Assay Plate s Due to Errors
6.Prepare assay  plates for disposal by  emptying the liquid off the plates.  Discard empty
assay plat es in a Bi ohazard waste receptacle .
9.10. Electronic Documentation
VR-TM-10293-FM01 is the assay  completion worksheet used w hensample pr eparatio n 
is performed either manually  or by automated methods.  A n assay  completion worksheet 
is not required for fully electronic /paperless batches where metadata is recorded in LIMS.
VR-TM-10293-FM02 is the manual sample preparation workshe et used when a utomate d 
sample preparation is not performed .  An assay  completio n worksheet is not required for 
fully  electronic /pape rless batche s where meta data is recorded in L IMS.
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FDA-CBER-2021-5683-0779564
VACCINE RESEA RCH TEST METHOD PEA RL RIVER, NY 
TITLE: Single -plex Luminex Assay for Qu antitation of 
IgGAntibodi es toSARS -CoV-2 S 1 Protein in Human 
SerumDoc Number: VR-TM-10293 Version: 1.0
Doc. Alias: NA
PFIZER CO NFIDENTIAL
Page 16Refer to VR -SOP-LC-10601 for instruction on maintaining the documentation of the data
package, if required. A Chain of Custody  form is not required for fully  
electronic/paperless batches where all met adata and r aw dat a isrecorde d in/uploaded to 
LIMS .
For batches created in LIMS the reagents, equipment, and incubation informat ion will be
captured a s metadata in LIMS, therefore those s ections can be N/A if the worksheets are
used, and the raw data will be up loaded to LI MS.
Raw data CSV files will be tr ansferred to the appropriate secure network drive upon 
assay  completion.   Any other file t ypes do not need to be transferred, and raw data is not 
required to be printed.
9.11. Data Export and Primary Data Review
3. F or LIMS runs, upload the data files back to LabWare LIMS a nd verify  that all
equipment and reagent information for assay  completion steps is accurately comple ted.
4. Complete the D ata Package chain of custody  form, VR -SOP-LC-10601 -FM14 , if
require d.
5. R eview as say documentation and/or LIMS metadata entry  for accuracy  andcompleteness 
prior to submitting docu mentation f or secondar y review .
NOTE: If technical problem s occurred with the assay  plate (plates are spilled or 
dropped, etc.)  
10.INTERPRETA TION OF RES ULTS
A qualified data reviewer anal yzes the data accordi ng to pre -specified acceptance criteria, as 
descri bed i n VR -SOP-LC-1112 0.
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FDA-CBER-2021-5683-0779565
VACCINE RESEA RCH TEST METHOD PEA RL RIVER, NY 
TITLE: Single -plex Luminex Assay for Qu antitation of 
IgGAntibodi es toSARS -CoV-2 S 1 Protein in Human 
SerumDoc Number: VR-TM-10293 Version: 1.0
Doc. Alias: NA
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Page 1711.REFERENCES
Table 5.General References
Document Title
VR-SOP-QU-10004 Document ation Pract ices in Vacci ne Research
VR-GWP -10041 Metadata Entry Pr ocedure in LabWare LIMS for Luminex Immunoassays
VR-SOP-QU-10726 Laboratory Devi ation Rep ort
VR-SOP-LC-10788 Labeling and Traceability of Reagents and Solutions
Table 6.Form References
Form Title
VR-TM-10293-FM01 Assay Complet ion Worksheet for SARS -CoV -2S1 IgG dLIA
VR-TM-10293-FM02 Manual Sample Preparation Work sheet for SARS -CoV -2 S1 IgG dLIA
VR-SOP-LC-10601 -FM14 Gene ric L uminex Assay Data Package Chain of Custody
Table 7. Speci fic References
Document Title
VR-SOP-LC-10222 Procedure for M aking Sample Predilutions with  
Robot
VR-SOP-LC-10627 Preparation of Assay Buffers and Solutions for  Assa ys
VR-SOP-LC-11114 Data Review Procedures for Dir ect Luminex I mmunoass ays Using Input Files or 
LabWare v5 LIMS
VR-SOP-LC-1112 0 Data Review Procedures f or Direct Luminex Immunoassays in LIM S v6.
VR-SOP-LC-11186 Runni ng the Method Using  Robot
VR-SOP-LC-11190 Standard Operating Procedure f or Ru nning Predilute Sample Method using 
 Robot
VR-SOP-LC-11295 Preparation of and Evaluation of  Microsp heres for use in Direct 
Luminex Assays
VR-RGR -RS-10747 Preparat ion of Reference Standard Seru m and Quality Control Samples for 
SARS -CoV -2 S1 and RBD Direc t Luminex Immunoass ays
VR-SOP-FE-10111 Bio-Plex Sys tem Operation and Maintenance
VR-SOP-LC-10586 Liquid Handling Techniques for Regulated Laboratory P rocedures
VR-SOP-LC-10601 Data P ackage Chain of Custody
VR-SOP-LC- 10774 Specimen Ma nagement Record Using LabWare LIMS
VR-SOP-FE-1088 7 Operation, Maintenance and Per formance Verificati on of  
Microplate Washers
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FDA-CBER-2021-5683-0779566
VACCINE RESEA RCH TEST METHOD PEA RL RIVER, NY 
TITLE: Single -plex Luminex Assay for Qu antitation of 
IgGAntibodi es toSARS -CoV-2 S 1 Protein in Human 
SerumDoc Number: VR-TM-10293 Version: 1.0
Doc. Alias: NA
PFIZER CO NFIDENTIAL
Page 1812.DOCUMENT VERSION MOD IFICAT ION S
12.1. CRIF Number: VR-CRIF -20-14611
Table 8. Detailed Changes
List detailed changes for document( s) 
Include section number(s) for eachList rati onale for each chan ge
New NA
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FDA-CBER-2021-5683-0779567
Document Approval Record
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FDA-CBER-2021-5683-0779568