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VACCINE RESEARCH SOP PEARL R IVER , NY
TITLE: Data Review Procedures for Direct Luminex 
Immunoassays in VRD LabWare LIMSDoc. Number:
VR-SOP-LC- 11120 Version: 4.0
Doc. Alia s: NA
PFIZER CONFIDENTIAL
Page 1
TABLE OF CONTENTS
LIST OF TABLES ................................ ................................ ................................ ..................... 2
1.HISTORICAL REVI SIONSUMMARY ................................ ................................ .............. 3
2.PURPOSE ................................ ................................ ................................ .............................. 3
3.SCOPE ................................ ................................ ................................ ................................ ...3
4.GLOSSARY ................................ ................................ ................................ .......................... 3
5.GENERAL ................................ ................................ ................................ ............................. 4
6.RESPONSIBILIT IES................................ ................................ ................................ ............ 5
7.SAFETY ................................ ................................ ................................ ................................ 5
8.MATERIAL S/EQUIPMENT ................................ ................................ ................................ 5
8.1.Hardware ................................ ................................ ................................ ................... 5
8.2.Software ................................ ................................ ................................ .................... 6
9.PROCEDURE ................................ ................................ ................................ ........................ 6
9.1.Review of VRD LabWare LIMS Metadata ................................ ............................... 6
9.2.Calculation of Assay Results – SAS Analysis ................................ .......................... 7
9.3.Assay Results Review ................................ ................................ ............................... 8
9.4.VRD LabWare LIMS ................................ ................................ .............................. 12
9.4.1. Upload of SAS Results ................................ ................................ ............... 12
9.4.2. Result Review ................................ ................................ ............................. 13
9.4.3. ................................ ................................ .......... 14
9.4.4. ................................ ....................... 15
9.4.5. Secondary  Data Check ................................ ................................ ................ 15
9.4.6. Lab Authorization ................................ ................................ ....................... 16
9.5.Deviations ................................ ................................ ................................ ................ 17
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FDA-CBER-2021-5683-0779531
VACCINE RESEARCH SOP PEARL R IVER , NY
TITLE: Data Review Procedures for Direct Luminex 
Immunoassays in VRD LabWare LIMSDoc. Number:
VR-SOP-LC- 11120 Version: 4.0
Doc. Alia s: NA
PFIZER CONFIDENTIAL
Page 210.REFERENCES ................................ ................................ ................................ .................. 17
11.DOCUMENT VERSION MOD IFICAT IONS ................................ ................................ ..18
11.1. CRIF Number: VR -CRIF-20 -14684 ................................ ................................ .....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. Review Rules for Repeat Tests ................................ ................................ .11
Table 6. General References ................................ ................................ ................... 17
Table 7. Form References ................................ ................................ ....................... 17
Table 8. Specific References ................................ ................................ .................. 18
Table 9. Detailed Changes ................................ ................................ ...................... 18
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FDA-CBER-2021-5683-0779532
VACCINE RESEARCH SOP PEARL R IVER , NY
TITLE: Data Review Procedures for Direct Luminex 
Immunoassays in VRD LabWare LIMSDoc. Number:
VR-SOP-LC- 11120 Version: 4.0
Doc. Alia s: NA
PFIZER CONFIDENTIAL
Page 31.HISTORICAL REVISION SUMMARY
Table 1.Chronological Summary of Previous Versions
Version # Effective 
DateOriginator Summary
4.0 Current Updated to accommodate the transition from LIMS v6 to 
LIMS v8and the addition of a new 
3.0 04-Sep- 2019 Upda ted to ac commodate pro cedures for new  
method and paperless processes
2.0 10-Mar-2017 Updated references section
1.0 16-Jan-2017 New  Document
2. PURPOSE
This document describes the da ta review process for al l Direct Lu minex I mmunoassay
(dLIA) data packages or electronic batches that utilize Vaccine Research & Deve lopment 
(VRD )LabWare Laboratory  Information Management Sy stem (LIMS ) version 8 (v8)or a 
subsequent version of VRD L abWare LIMS .
3.SCOPE
This procedure applies to VRD personnel who perform data review for Direct Luminex 
Immunoass ays in support of clinic al and non-clinical studies. The calculation of assay  
results and the transfer of these results to VRD LabWare LIMS v8 , or subsequent versions,
for auth orization are in the scope of the procedure. For the remainder of this document, the 
term VRD LabWare LIMS is inclusive of v8 through the most current version of LIMS .
Table 2.Vaccine Research Functional Units
Functional Units Location
Vaccine Research & Development Pearl River
4.GLOSSAR Y
Table 3.Terms and Definitions
TERM DEFINITION
Assay Plate 96-well microtiter plate used to perform the Luminex 
assay
Batch
Bio-Plex Bio-Rad propri etary Luminex Suspension Array System
and Software
BLQ Below  Limit of Quantitation
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FDA-CBER-2021-5683-0779533
VACCINE RESEARCH SOP PEARL R IVER , NY
TITLE: Data Review Procedures for Direct Luminex 
Immunoassays in VRD LabWare LIMSDoc. Number:
VR-SOP-LC- 11120 Version: 4.0
Doc. Alia s: NA
PFIZER CONFIDENTIAL
Page 4Table 3.Terms and Definitions
TERM DEFINITION
CSV Comma-s eparated value s file
DAP Data Analysis Portal
dLIA Direct Luminex ImmunoAssay
Lab Au thorize The acti on to approve the data results in VRD
LabWare LIMS
LDR Laboratory Deviation Report
LIMS Laboratory Information Management Syst em
LLOQ Lower limit of Quantitation
Metadata Assay -related inf ormation captured in VRD
LabWare LIMS (e g,reagents, equipment, instruments)
MFI Median Fluorescent Intensity
NR Not Reported or Not Reportable
QCS Quality Control Serum
QNS Quantity Not Sufficient
RSS or ST D Reference Standard S ample
SAS Statistical Analysis System
5.GENERAL
The dLIA measures antigen -specific antibodies in unknown se rum samples .Specific 
antibodies from theserum samples are detected using  reporter
antibody . The f luorescence signal is directl y proportional to the amount of antigen specific 
antibodies present in the se rum.
For assay  plates prepared with the or methods,  
is equivalent to one batch.
For assay  plates prepared with the  method, one batch contains  
For clinical and toxicology  studies, the data re viewer must be qualifi ed on this procedure 
andNOT be the same analy st who has performed laboratory  activities (eg ,robot 
operat or)to generate the ra w data and/ or who has carried out the primary  documentation 
review , if required, upon completion of the appropriate test method.
It is acceptable for the data reviewer to sign off o n batch -related comments in 
VRD LabWare LIMS when nece ssary.
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FDA-CBER-2021-5683-0779534
VACCINE RESEARCH SOP PEARL R IVER , NY
TITLE: Data Review Procedures for Direct Luminex 
Immunoassays in VRD LabWare LIMSDoc. Number:
VR-SOP-LC- 11120 Version: 4.0
Doc. Alia s: NA
PFIZER CONFIDENTIAL
Page 5Following the successful upload of raw data, the results are calculated in Pfizer’s 
proprietary  SAS ®-based data anal ysisprogram. The results output file i s examined, and 
the data is entered into VRD L abWare LIMS .The data reviewer verifies that t he results 
are correct ly entered and au thorizes the batch results in VRD L abWare LIMS .
In the event that VRD LabWare LIMS is una vailable, sample preparation and assay 
completion worksheets should be filled out to capture the required metadata. These 
worksh eets must be scanned i nto VRD L abWare LIMS and a ssociated with the 
appropriate batch(es) during the data review procedures.
6.RESPONSIBILITIES
All personnel and posit ions referred to in this procedure are considered to have an 
alternate.
An alternate must en sure that they  are tra ined and knowledgeable wit h the process.
Table 4.Roles and Responsibilities
Role Responsibilities
Analyst Ensure s the authenticity, integrity, completeness, accuracy, quality and compliance 
of dLIA meta-data.
Data Reviewer Ensur es the au thenticity, integrity, completeness, accuracy, quality and compliance 
of dLIA meta-data.
Processes data w ith Pfizer’s proprietary, cu stom SAS® program .
Performs results entry in VRD LabWare LIMS .
Creates replicate tests in VRD LabWare LIMS .
Perfor ms lab au thorization of batches in VRD LabWare LIMS .
Initiates LDRs, as required .
Supervisor Ensures that the data reviewer is properly train ed on the appropriate SOPs .
Ensures all LDRs associated with data packages are closed in the appropriate time 
fram e.
7.SAFE TY
N/A
8.MATERIALS/EQUIPMENT
8.1. H ardware
Computer
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FDA-CBER-2021-5683-0779535
VACCINE RESEARCH SOP PEARL R IVER , NY
TITLE: Data Review Procedures for Direct Luminex 
Immunoassays in VRD LabWare LIMSDoc. Number:
VR-SOP-LC- 11120 Version: 4.0
Doc. Alia s: NA
PFIZER CONFIDENTIAL
Page 68.2.Software
Active Pfizer Computer Account
VRD LabWa re LIMS user account with a LabRevi ewer or La b Manager role; access to 
VRD LabWare LIMS production environment
Access to the appropriate assay  specifi c link(s) i nthe Data Anal ysis Portal
9.PROCEDURE
Data review encompasses three major tasks:
Review of me tadata entered in VRD LabWare LIMS ; in the event that 
VRD LabWare LIMS is unavailable for metadata entry , the data reviewer 
should review the sample pre paration and assay  completion worksheets
Calculation of Assay  Results
Upload of Assay  Results to VRD L abWare LIMS and review of Assay  Results in 
VRD LabWare LIMS
9.1.Review of VRD LabWare LIMS Metad ata
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FDA-CBER-2021-5683-0779536
VACCINE RESEARCH SOP PEARL R IVER , NY
TITLE: Data Review Procedures for Direct Luminex 
Immunoassays in VRD LabWare LIMSDoc. Number:
VR-SOP-LC- 11120 Version: 4.0
Doc. Alia s: NA
PFIZER CONFIDENTIAL
Page 79.2. C alculatio n of Assay Results –SAS Analysis
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FDA-CBER-2021-5683-0779537
VACCINE RESEARCH SOP PEARL R IVER , NY
TITLE: Data Review Procedures for Direct Luminex 
Immunoassays in VRD LabWare LIMSDoc. Number:
VR-SOP-LC- 11120 Version: 4.0
Doc. Alia s: NA
PFIZER CONFIDENTIAL
Page 89.3.Assa y Results Review
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FDA-CBER-2021-5683-0779538
VACCINE RESEARCH SOP PEARL R IVER , NY
TITLE: Data Review Procedures for Direct Luminex 
Immunoassays in VRD LabWare LIMSDoc. Number:
VR-SOP-LC- 11120 Version: 4.0
Doc. Alia s: NA
PFIZER CONFIDENTIAL
Page 9
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FDA-CBER-2021-5683-0779539
VACCINE RESEARCH SOP PEARL R IVER , NY
TITLE: Data Review Procedures for Direct Luminex 
Immunoassays in VRD LabWare LIMSDoc. Number:
VR-SOP-LC- 11120 Version: 4.0
Doc. Alia s: NA
PFIZER CONFIDENTIAL
Page 10
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FDA-CBER-2021-5683-0779540
VACCINE RESEARCH SOP PEARL R IVER , NY
TITLE: Data Review Procedures for Direct Luminex 
Immunoassays in VRD LabWare LIMSDoc. Number:
VR-SOP-LC- 11120 Version: 4.0
Doc. Alia s: NA
PFIZER CONFIDENTIAL
Page 11Table 5.Review Rules for Repeat Tests
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FDA-CBER-2021-5683-0779541
VACCINE RESEARCH SOP PEARL R IVER , NY
TITLE: Data Review Procedures for Direct Luminex 
Immunoassays in VRD LabWare LIMSDoc. Number:
VR-SOP-LC- 11120 Version: 4.0
Doc. Alia s: NA
PFIZER CONFIDENTIAL
Page 12Table 5.Review Rules for Repeat Tests
9.4.VRD LabWare LIM S
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FDA-CBER-2021-5683-0779542
VACCINE RESEARCH SOP PEARL R IVER , NY
TITLE: Data Review Procedures for Direct Luminex 
Immunoassays in VRD LabWare LIMSDoc. Number:
VR-SOP-LC- 11120 Version: 4.0
Doc. Alia s: NA
PFIZER CONFIDENTIAL
Page 139.4.2. Result Review
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FDA-CBER-2021-5683-0779543
VACCINE RESEARCH SOP PEARL R IVER , NY
TITLE: Data Review Procedures for Direct Luminex 
Immunoassays in VRD LabWare LIMSDoc. Number:
VR-SOP-LC- 11120 Version: 4.0
Doc. Alia s: NA
PFIZER CONFIDENTIAL
Page 14
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FDA-CBER-2021-5683-0779544
VACCINE RESEARCH SOP PEARL R IVER , NY
TITLE: Data Review Procedures for Direct Luminex 
Immunoassays in VRD LabWare LIMSDoc. Number:
VR-SOP-LC- 11120 Version: 4.0
Doc. Alia s: NA
PFIZER CONFIDENTIAL
Page 159.4.5. Secondary Data Check
Prior to lab authorization, a secondary  data revie wer should verify  the information associated 
with each batch to ensure completeness. Secondary  review should be completed wit hin three 
weeks of the completion of data r eview. The secondary  data re viewer must not be the 
analyst who perf ormed the sample p reparation, assay  completion or the initial data review.
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FDA-CBER-2021-5683-0779545
VACCINE RESEARCH SOP PEARL R IVER , NY
TITLE: Data Review Procedures for Direct Luminex 
Immunoassays in VRD LabWare LIMSDoc. Number:
VR-SOP-LC- 11120 Version: 4.0
Doc. Alia s: NA
PFIZER CONFIDENTIAL
Page 169.4.6. Lab Authorization
 
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FDA-CBER-2021-5683-0779546
VACCINE RESEARCH SOP PEARL R IVER , NY
TITLE: Data Review Procedures for Direct Luminex 
Immunoassays in VRD LabWare LIMSDoc. Number:
VR-SOP-LC- 11120 Version: 4.0
Doc. Alia s: NA
PFIZER CONFIDENTIAL
Page 179.5.Deviations
Refer to V R-SOP-QU-10726 for Labor atory  Devia tions.  
 
10.REFERE NCES
Table 6.General References
Docu ment Title
VR-SOP-QU-10004 Docume ntation Practice sin Vaccine Research
VR-TM-10148
VR-TM-10152
VR-TM-10199
VR-TM-10200
VR-TM-10207
VR-TM-1021 5
VR-TM-10220
VR-TM-10225
VR-TM-10260
VR-TM-10265
VR-TM-10274
VR-TM-1029 3 Single -plex Luminex Assay for Qua ntitation of IgG Anti bodies to 
SARS -CoV -2 S1 Protein in Human Serum
VR-TM-10294 Single -plex Lumine x Assay for Quantitation of IgG Antibo dies to 
SARS -CoV -2 RBD Protein in Human Serum
VR-TM-10309 Single-plex Lumin ex Assay for Quantitation of IgG Antibodies to 
SARS -CoV -2 Spike Pro tein in Human Serum
Table 7. F orm References
Form Title
N/A N/A
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FDA-CBER-2021-5683-0779547
VACCINE RESEARCH SOP PEARL R IVER , NY
TITLE: Data Review Procedures for Direct Luminex 
Immunoassays in VRD LabWare LIMSDoc. Number:
VR-SOP-LC- 11120 Version: 4.0
Doc. Alia s: NA
PFIZER CONFIDENTIAL
Page 18Table 8.Specific References
Document Title
VR-SOP-QU-10726 Laborator yDeviat ionReport
11.DOCUMENT VERSION MOD IFICATIONS
11.1. CRIF N umber: VR -CRIF -20-14684
Table 9.Detailed Changes
List detailed changes for document(s)
Include section number(s) for eachList rationale for each change
Throughout Documen t:Remov ed
references to LabWare v6 LIMSLabWare v6 LIMS has b een updated to LabWare v8 LIMS. For the 
purposes of this document, the term VRD LabWare LIMS refer s to 
version 8.0 and all subseque nt versions.
5.0 General: Removed reference to 
 methodThe  sample prep me thod has been 
decom missioned.
9.3 Assay Results Review: Added 
detailed list of All  have been defined in detail, including the 
circumstances under which th ey should be triggered by SAS.
9.3 Ass ay Res ultsReview: Adde d 
review r ules asso ciated with  is a new  therefor e specific review rules had not yet 
been d efined.
9.4.2 Result Review: Included detail ed 
steps associated with manual rejection 
of indi vidual testsDetailed instr uctions associated w ith manual rejection of individual 
tests had no t previously been defined.
9.4.2 Result Review: Included detailed 
steps associat ed with manu al entr y of 
resultsDetailed instructions associated w ith ma nual entry of results ha d not 
previo usly b een defined .
9.4.5Secondary Da ta Check: Included
steps associated with a secondary data 
checkInstructions associated with a secondary data check had not 
previously been defined.
10.0 Reference s:Added new  test 
methods to the reference sectionNew assays have been qualified since the last update of this 
document.
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FDA-CBER-2021-5683-0779548
Document Approval Record
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FDA-CBER-2021-5683-0779549