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PF-07302048 : Method Validation Report for the Elecsys Anti -SARS -CoV- 2 Assay
VR-MVR-10081 , Ver. 2.0
PFIZER CONF IDENTIAL
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Title: Method Validation Report for the Elecsy s Anti- SARS -CoV -2 Assay
Study Number: N/A
Parent Compound Number(s): PF-07302048
Alterna tive Compound Identifiers: N/A
Pfizer Vaccine Research and Development
401 N. Middletown Rd.
Pearl R iver, NY
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Page 2Title: Method Validation Report for the Elecsy s Anti- SARS -CoV -2 Assay
PRINCIPAL INVESTIGATOR: Warren Kalina, Direct orand Head of Serology and
Diagnostic Assay Development , Clinical and Diagnostic Assay Development
CONTRIBUTING SCIENTIST (S): ,
PREPARED BY:
APPROVED BY:
Warren Kalina , PhD
Directorand Head of Serology and D iagnostic Assay Development , Clinical and Diagnostic
Assay Development
Charles Tan, Ph D
Senior Director, Earl y Clinical Development Biostatistics
David Cooper , PhD
Executive Direc tor, H igh-throughput C linical Immunoassay s and Dia gnostics
Michael Pride , PhD
Executive Director , Clinical and Diagnostic Assay Deve lopment
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Page 3Title: Method Validation Report for the Elecsy s Anti- SARS -CoV -2 Assay
SYNOPSIS
The Roche Elec sys Anti- SARS -CoV -2 assay is an FDA emergency use authorized
qualitative test for detection of antibodies t o SARS -CoV -2 in human serum and plasma .The
assay, performed on the Roche Cobas® platfor m,detects antibodies to the SARS -CoV-2 N
prote in inserum and pl asma samples . This document describes the validation results of this
assay and confi rmsthattheassay is fit for its intended use in epidemiological or clinical trials
designed to evaluate the effic acy of Pfizer’ s SARS -CoV-2 vaccine c andidate .Assay
sensitiv ityand specificity were evaluated and are comparable to thoseobserved by Roche
Diagnostics and other laboratories. O verall assay performance is summarized in this
validation report .
Key Validation O utcomes
Clinical Perfor manceParameter Percent
Agreem ent(%)95% One- Sided
Lower Confidence Limit (%)
Negative Percent Agreement to pre -COVID -19
serum samples (Clinical Specificity)100.00 97.72
Positive Percent Agreement to human COVID -19
serum samples (Clinical Sensitivi ty)93.50 89.86
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Page 4TABLE OF CONTENTS
SYNOPSI S................................ ................................ ................................ ................................ .3
LIST OF TABLES ................................ ................................ ................................ ..................... 5
LIST OF FIGURES ................................ ................................ ................................ ................... 5
1.OBJECTI VES ................................ ................................ ................................ ........................ 6
2.INTRODUCTION ................................ ................................ ................................ ................. 6
3.GLOSSARY ................................ ................................ ................................ .......................... 7
4.MATERIAL S AND MET HODS ................................ ................................ ........................... 8
4.1.Materials ................................ ................................ ................................ .................... 8
4.2.Critical Reagents ................................ ................................ ................................ .......8
4.3.Method ................................ ................................ ................................ ...................... 8
4.4.Quali fied Equipment used for the Method Validation ................................ .............. 9
4.4.1. Data Handling................................ ................................ ............................... 9
4.4.1.1. Data Processing and Output via Instrument Software ................ 9
5.EXPERI MENTAL OUTLIN E................................ ................................ ............................. 10
6.RESUL TS AND DI SCUSSION ................................ ................................ .......................... 10
6.1.Clinical Specificity / Test Agreement Evaluation ................................ ................... 11
6.1.1.Clinical Specificity / Test Agreem ent Evaluation Study Design ................ 11
6.1.2. Clinical Specificity / Test Agreement Evaluation Analy sis....................... 11
6.1.3. Acceptance Criteria ................................ ................................ .................... 11
6.1.4. Clinical Specificity / Test Agreement Evaluation Results ......................... 11
6.2.Clinical Sensitivity / Test Agreement Evaluation ................................ ................... 12
6.2.1. Clinical Sensitivity / Test Agreement Evaluation Study Design ................ 12
6.2.2. Clinical Sensitivity / Test Agreement Evaluation Analy sis....................... 12
6.2.3. Acceptance Criteria ................................ ................................ .................... 12
6.2.4. Clinical Sensitivity / Test Agreement Evaluation Results .......................... 12
7.CONCL USION ................................ ................................ ................................ .................... 13
8.DEVIATIONS ................................ ................................ ................................ ..................... 13
9.SUPPORTING DOCUMENTATION ................................ ................................ ................. 13
10.SUPPL EMENTAL INFORM ATION ................................ ................................ ............... 13
11.SUPPORTIVE TABLES ................................ ................................ ................................ ...15
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Page 5LIST OF TABLES
Table 1. Terms and Definitions ................................ ................................ ................ 7
Table 2. Qualified Equipment used for the Method Validation ............................... 9
Table 3. Cobas ®Elecs ys Anti- SARS -CoV -2 Result Options..................................9
Table 4. List of Attachments ................................ ................................ ................... 11
Table 5. Negative Agreement in Serum Samples Obtained Prior to COVI D-
19 ................................ ................................ ................................ .............. 12
Table 6. Positive Agreement in COVID -19 PCR Confirmed
Serum Samples ................................ ................................ ......................... 13
LIST OF FIGURES
Figure 1. Overview of the Elecs ys Anti- SARS -CoV -2 Assay ................................ ...7
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Page 6Title:Method Vali dation Report f or the Elecsy s Anti- SARS -CoV -2 Assay
Study Number: N/A
Functional Area: Vaccine Research and Development
Test Facility: Pfize r Vaccine Research, 401 North Middletown Road,
Pearl Riv er, NY 10965
Study/Testing Initiat ion Date: 26 Ju ly2020
Study/ TestingCompletion Date: 26 July 2020
1.OBJECTIVES
This report summariz es the results fo r thevalidation of the FDA emergency use a uthorization
(EUA)-approved El ecsys Anti- SARS-CoV -2 assay as performed on th e Roche Cobas ®
instrument (Cobas ® analyzer)for its int ended use i n clinical trials designed to evaluate
the effi cacyof Pfizer’s SAR S-Co V-2 vaccine candi date or other epidemiol ogical studies.
Performance param eters, including clinical sensitivity and clinical s pecific ity, were
evalu ated, as well a s overall assa yperformance. This validation provides documented
evide nce that the Elec sys Anti-SARS -CoV -2 assay , when performed in accordance with the
test method and standar d operating proce dures (SOPs) by qualified personne l, is sui table for
its intende d use.
2. INTR ODUCTION
The Roche Elec sys Anti- SARS -CoV -2 assay is currentl ybeing marke tedunder an EUA for
detecting the presence of antibodies to theN protein of SARS -CoV -2 (antigen not
incor porated i n Pfizer’s SARS -CoV-2 v accine c andidate) . The performancecharacte ristics
of the Elecsys Anti-SARS- CoV-2 assay aredescrib ed in the package Instructions for
Use(IFU).1In addition, a correspondence ( VR-MVR -10081 -ATT02)2from Roc he
Diagnostics (In dianapolis, I N)is pro vided in support of this method validation .
The Pfizer as say Test Met hod, VR-TM-10304,3describes thelaboratory method for the
detectio n ofanti-SAR S-CoV -2N protei n anti bodies inserum or plas mausing theFDA EUA
Elecsys Anti-SARS -CoV -2 assay (Roche Diag nostics, Indianapolis, IN). The Elecsys
Anti-SARS -CoV-2 assay i sa rapid, automated in vi tro diagn ostic test for the qual itative
detection ofSARS-CoV -2 N protein specific antibo dies in serum or plas masamples. The
assay is marketed as an aid in identif ying individu als with an adapt iveimmune response t o
SARS -CoV -2, whichwould indicate a recent or p riorinfection . Detecti on of N protein
antibodies toSARS -CoV -2is carried out by a two- step immunoas saymethod w here biotin
andruthenium N protein conjuga tes are incub ated with human serum or plasma. Streptavidin
coated pa ramagnetic b eads are then added inthe second step to isol ate Nprotein /antibody
complexes an d chemilumine scent emissions are measur ed bya photomultiplie r (Figure 1).
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Page 7Figure 1.Overview of the Elecsys Anti -SARS -CoV -2 Assay
The Elecs ys Anti- SARS -CoV-2 assay hasbeen evaluated b y oth er laboratories4and
demonstrate dcomparable clinical sensi tivity (86.1%,CI76.5-92.8; n=79 samples) in
samples obtained ≥14 day s post- COVID -19 diagnosis andclinical specificity(100%) to that
described in Roche ’sIFU1andEUA (EUA200514/A001 ).Although sensitivity was lower in
that evaluation compared toRoche’s IFU1claims (99.5%) ,the above r eport used a different
sample set of smaller size. However , specificity in the smaller cohort of subjects (n=472)
tested in the evalu ation described above was highly compar able to Roche ’sreported
specificit y (99.8 %),which used a much larger cohort of negative samples (n= 10,453).
Thismethod validation re portsuccessfully fulfills the object ives of the v alidation protocol
VR-MVP -100755and demonstrates that the assay , when performed according to the
manufac turer ’s instructions in Pe arl River, NY , is suitable for use
in clinical trials designed to evaluate the effi cacyof Pfizer’s SAR S-Co V-2 vaccine candi date
or otherepidemiolo gical studies.
3.GLOS SARY
Table 1.Terms and Definitions
Term Definition
ACOV2 Ca l1 Negative calibrator 1
ACOV2 Ca l2 Positive calibr ator 2
Coate d Microspheres Streptavidin coated bead s at 0.72mg/m L
COI Cutoff Index
COVID‑19 Coronav irus Disease 2 019
Elecsys
Anti‑SARS ‑CoV ‑2An immunoas say intended for qualitative detectionof antibodies to SAR S‑CoV‑ 2 in
human serum and plasma
EUA Emergency Use A uthorizat ion
IFU Instructions for Use
LIMS Laboratory Informatio n Manage mentSystem
OHW Occupational Health and Well ness
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Page 8Table 1.Terms and Definitions
Term Definition
QCS Qualit y Control Samples
RGR Reagent Quali fication Report
Roche Cobas ®
Instrume ntA fully au tomated analy zer that uses a p atented El ectro ChemiLuminescence (ECL)
technolog y for immunoassay analysis (ie,Cobas® )
Room Temperature(RT) Room temperat ure in this SOP is defined as 20°C with a range of 18-25° C.
SARS Severe Acu te Res piratorySyndrom e
SOP Standard Operating Pr ocedure
SM Sample Managemen t
TM Test M ethod
VPL Validation Plan
VRD Vaccin eResearch and Develo pment
4.MATERIALS AND METHOD S
4.1.Materials
Unique re agents obtained for this val idation a relisted in Support iveTable 11.1, and al l other
material s used are described in the SOPs referenced in Section 10. Specific deta ils regarding
reagent catalog a nd lo t numb ers and expiration dates, as well as th e instrument identific ation
numbers and mainten ance de tails are captured by the Roche Cobas® system soft ware or
documented in theassay worksheets w ithin data packages or electronic ally stored in LIMS.
Allother reagents and supplie s are described in VR-TM-10304 .3
4.2.Critical Reagents
The criti cal reage nts, including qualit y control samples (QCS), used in thi s assay validation
are liste d in S upportive Table 11.1. Panel samples u sed in this valida tion are described i n
Supportive Tables 11.2 and 11.3. Briefly , serum samples obtained
between days post-PCR dia gnosiswere received from
and used to assess clinical sensitivit y.Clinical specificity was
assessed with negative serum samples from blood dr aws that pr e-date
COVID -19 and w ere obtained from
4.3. Me thod
The Elecs ys Ant i-
SARS -CoV- 2 assay is an FDA EUA approved assay for the rapid detectio n
of SARS -CoV-2 antibody inserum or pla sma. The test is i ntended for use as an a id in
identifying individuals wit han adaptive immune response to SARS -CoV-2, indica ting recent
or priorinfection. The ass ay was performed according to the manufa cturer ’s instructions.1
All c ritical reage ntsare provi ded in Roche ’s assay kit.
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Page 9Test Method VR -TM-103043describes the procedures to perform the Elecsy s
Anti-SARS -CoV -2 assay on serum sa mples. Barcoded samples were processed for testing as
follows:
1.Analy zerwas ca librated .Refer to VR -TM-103043for calibration procedure.
2. P atient serum samples were thawed at RT for 20 ±10 minutes.
3. Sa mple barc odes were scanned and assign ed an Anti-SARS -CoV -2test.
4. S ample v ials were uncapp edand placed in the appropriate rack.
5. R acks w ere placed on th e analyzer.
6. Th e analyzerwasstarted.
7. When the assay wasfinishe d,raw data (.csv file) w asextracted foranalysis.
4.4.Qualified Equipment used for the Method Validation
Table 2.Qualified Equipment used for the Method Validation
Descrip tion Manufacturer Model # Equip ment ID # Calibration
DateExpiration
Date
cobas analyzer Roche Jul-20 Jul-21
4C Cold Room Dec-19 Dec-20
-80C Freezer Sep-19 Sep-20
4.4.1. Data Handling
4.4.1.1. D ata Processing and O utput via I nstrument Software
1.Data results were pre sented in qu alitative “Positive ”or “Negat ive”and cutoff index
(COI) v alue formats. The results were interpreted automatically by theRoche Cobas®
softwa re and shown inthe“Vie w Results” window. The El ecsys Anti-SARS- CoV -2
assay prov ides positive/negati ve test res ults based on N speci fic antib ody levels above or
below a predetermined COI (Table3).
Table3. Co bas®Elecsys An ti-SARS -CoV-2 ResultOptions
Result Te xt Sample COI
ValueNegative Control Positive Co ntrol
SARS -CoV -2 Positi ve ≥1.0 <1.0 ≥1.0
SAR S-CoV-2 Negative <1.0 <1.0 ≥1.0
INVALID N/A >1.0 <1.0
INVALIDaInstrumen t error Instrume nt error Instru ment error
a. different error codes are po ssible on the R oche Cobas® system
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Page 10For testin g validity ,the El ecsys Anti-S ARS -CoV -2 assay must have b oth positiveand
negative controls that pass acceptance criter ia at the beginning and end of an a ssay run.
Anassay runinvolve stestin g racks of samples . A rack will hold sample vials,
whichmay include calibrators and /orcontrol
s.
2. N umerical da ta in the formof COI values w ere captured for each sam ple, cali brator and
control . TheCOI values wereused to de termine descr iptive statist ics only .
3.Two controls were tested with every assayrun:
a.Negat ive Control ( Neg) –Ensures t hatthe assa y isretur ning res ults consistent with a
known SARS -CoV -2 anti body negative sam ple. The negative control passes if it
produces a “negative” result. The negati ve contro l was tested in th e beginning and
endof the ass ay run. Both se ts of controlsmust pass to validate the sa mple results
within the run.
b. Po sitive control (P os) – Ensur es that the assay is returning re sults consistent with a
known SA RS-CoV -2 antibo dy positiv e samples .The positive contr ol passes if it
produces a “positi ve”resul t. The po sitive control was tested in the beginning and end
of the a ssay run. B oth sets of c ontrols must pass to validate the sampl e resultswithi n
the run .
4. A s described per the validation protocol VR-MVP -10075 ,5failed test s and samp les were
repeated as required , per VR -SOP-LC-11296 .6A fail ed test is a sample that does not
generate a reporta ble result.
5.EXPERIME NTAL OU TLINE
The validation of the Elecsy s SARS -CoV -2 assay was performed as described in
VR-MVP -10075 .5The c ritical reagents, includ ingquality control samp les (QCS), use d in
this assay validation are l isted inSupportive Table 11.1. Formulation of the QCS are
documented in V R-RGR -QC-10753 .7The human seru m sampl es used inthis validation are
listed in Supporti veTables 11.2 and 11.3.
Specific details re gardi ng reagent catalog and lo t numbe rs and expir ationdates, as we ll as t he
instrument identific ation numbers and maintenan cedetails is captured by the Roche Cobas ®
system software or documented in the assay worksheets w ithin data pa ckages or
electro nical ly stored in LIMS . All other re agents and s upplies are de scribed in
VR-TM-10304.3
6. RE SUL TS AND D ISCUSSION
Attachments in support of this va lidatio n are d escribed i n Table 4. Clinic al sensitivity ,and
specificit y data used for the validation anal yses descri bedhereinare li sted in
VR-MVR-10081 -ATT0 1(see Section 9).Roche pr ovided correspondence to the FDA in
support of this method validation thatis provided in VR -MVR -10081 -ATT0 2.2
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Page 11Table 4. L ist of Attac hments
Nam e Content
VR-MVR -1008 1-ATT01 (see Section 9 ) Clinical se nsitivi ty and clinical specificity data l istings
VR-MVR-1008 1-ATT022Roche c orrespo ndence to FDA
VR-MVR -10081 -ATT038Roles and responsibilities for the method validation
6.1.Clinical Specif icity / Test Agreement Evaluation
6.1.1. Clinical Specificity / Test A greement E valuation St udyDesign
Thespecificit y of the Elecsys Anti -SARS -CoV -2 as say wasevalu ated using negat ive
(pre-COVID -19) serum s pecimens described in Supportive Table 11.3.
negative serum samples w eretested in the E lecsysAnti-SA RS-CoV-2 assay . Clinical
serum s ample swere obtaine d from
The serum specimens were from blood dra ws tha t
pre-date C OVID -19 Though this method va lidation did not evaluate
specificityto other known coronaviruses , such astudy was performed by Roche and
demonstrated th at the Elecsy s Anti -SARS -CoV -2 assay was not reactive with
non-SARS -CoV -2 coron aviruses (ie, HKU 1, NL63, 229E or O C43).1
Resu ltsare rep orted as the numb er of concordant nega tiveresults out of the total num berof
samples te sted.
6.1.2. Clinical Specificity / Test Agreement E valuation Analy sis
TheNegative P ercent A greemen t (NPA ) wasdefined as the percentag e of t he nega tive
samples confirmed by the assay :
NPA= 100* Number of A greed Negatives /Total Nu mber of Negatives Samples with Valid
Results.
The one -sided lo wer 95% confiden ce bound for NPA wasdeterm ined by the exa ct
(Clopper -Pearson) method.
6.1.3. Acceptance C riteri a
Resultsaredescriptiv ein na ture and c ompared to results provide d inRoche’s IFU1and EUA.
6.1.4. Clinical Sp ecificity / Test Agreement Evaluation Results
A summary of the Elecsys a nti-SARS -CoV -2 assa ytestin g on negative serum sampl esthat
pre-date COVID -19areshown i n Table 5. T he assay was100% specific (n= ) in not
identify ing SARS -CoV -2 antibodies in pre -COVID -19 p andemic samples .
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Page 12Table 5.Negative Agre ement in Serum Sa mple s Obtained Prior to COV ID-19
Clinical Perfor mance Frequency of Elecsys
Anti -SARS -CoV -2
Negative SamplesPercent
Agreem entTotal
Samples
Tested95% One- Sided
Lower Confidence Limit
(%)
Negative Percent
Agreement100.0 0 97.72
6.2. C linicalSensitivit y/ Test Agreem entEvalua tion
6.2.1. Clinical Sensit ivity/ Test Agreemen t Evaluation Study Design
The sensitivi tyof the Ele csys Anti -SARS -CoV -2 assay wasevaluated using
sera from indivi duals with a PCR conf irmed COVID-19 diagnosi s. All serum
sample s wereobtained days post-PCR dia gnosis. samples
weretested in the E lecsys Anti-S ARS -CoV -2
assay andwere obtained from
.The sampl e IDs arelistedin
Support iveTable 11.2.
Result s arereported as the numb er of concord ant positiveresult s out of the total number of
samples tested .
6.2.2. Clinical Sensitivity / Tes t Agreement Evaluation Analysis
The Positive Perce nt Agre ement (PPA) wasdefine d asthe per centage of the positi ve sampl es
detected by the assay :
PPA = 100*Number of Agree d Positives/ Total Number of Positive Sampl eswith Valid
Results.
The one -sided l ower 95% confidence bound for PPA wasdetermined bythe exact
(Clopper -Pearson) method.
6.2.3. Acceptance C riteria
Results aredescriptive in nature and compared to re sults provided in Roc he’s IFU1and EUA
(EUA200514/A001 ).
6.2.4. Clinical Sensitivity / Test A greem entEvaluati onResults
A summary of the Elec sys anti-SARS -CoV -2 assay testing on COVID -19
serum samples is shown i n Table 6. The assay detected the presence of SARS -CoV -2
antibod ies in COVID -19 convalescent se rum s amples with a percent
agreement of93.50%.
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Page 13Table 6.Positive Agre emen t in COVID -19 PCR Confirmed Serum
Samples
Clinical Perform ance Frequency of Elecsys
Anti -SARS -CoV -2
Positiv eSam plesPercent
Agreem entTotal
Sam ples
Tested95% One- Sided
Lower Confi dence
Limit (%)
Positive P ercent
Agreement93.50 89.86
7. CO NCLUSIO N
Theresul ts documented in this report for the Elecsy s SARS -CoV -2 assay indicate the Roche
assay was 100% specific when analyzing pre-COVID -19 p andemic samples and 93.5%
sensiti ve in identify ing antibod ies in samples from subj ects days after a COVID -19 PCR
diagnosis . Thespecificity (100%) and sensitivity (93.5%) demonstrated in this report align
similarly to Roche’s IFU1of 99.8% (n=10 ,453samples obtai ned before Dec ember 2019;
CI99.69-99.88%)specificity and 99.5% (n=496 samples with a PCR confirmed
SARS -CoV -2 infection; CI 97.0-100%) sensitivi tyin symptomatic patients ≥14 da ys
post-PCR confir mation; se nsitivity was 8 5.3% in samples c ollected 7-13 day s post- PCR
confirmation .
In addition, the results of this metho d valid ation aresimilar to what was observed in a
previous evaluation of the Elecs ysAnti-SA RS-CoV-2 assayconducted b y Public Health
Englan d4in which specific ity of100% (CI 99.1- 100) and sensit ivity of 86.1% (CI 76.5-92.8)
was o bserved using 472 negative samples and 79 convalescent patient sa mple s, respectivel y.
Overall, th ese data provid e evidence t hat the assay is validated and suitable for its intended
usein clinical trials designed to evalu ate the efficacy of Pfizer’s SAR S-CoV -2 va ccine
candi date or other epidemiolo gical s tudies. The ass ay dem onstrated acceptab le clinical
sensitivityandclinic al specificity, comparable to that described in Roche ’sIFU1and EUA
(EUA200514/A001 ), and the evaluation performed at Public He alth En gland.4
8. DEVIATIONS
N/A
9. SUPPORTING DOCUMENTA TION
1. VR-MVR -10081 -ATT01 -Supportive Data for VR -MVR -10081 – Validation Data
Listing .
10.SUPPLEMENTAL INFORMATION
1. Elecs ys Anti-SARS -CoV-2Instruction s For Use. 09203095501 , Version 4.0 .July 2020.
(VR-MVR -10081 -Supplemental Info) .
2. VR- MVR -10081 -ATT0 2, Supportive D ata for VR -MVR -10081 -Roche
Correspondence to FD A In Support of Pfizer Method Validation .
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PFIZER CONF IDENTIAL
Page 143. VR-TM-10304, Test Method f or the SARS -CoV-2 Nucleoca psid(N) Anti gen Detect ion
Assay .
4. Duggan J. Evaluation of Roche Elecs ys Anti- SARS- CoV -2 serology assay for the
detection of anti -SARS -CoV -2 antibodies. In: Publis hed 11 Jun 2020. L ondon: Public
Health England; 2020: 17 pages.
5. VR-MVP -10075, Protoc ol for the Method Validation of t heElecs ys Anti-SARS -CoV -2
Assay.
6. VR-SOP-LC-11296, Data Rev iew forSARS-CoV -2 Nucleocapsid Antigen Dete ction
Assay .
7. VR-RGR -QC-10753, Qualit y Control S ampleFormula tion for Elecsys
Anti- SARS -CoV -2 Assa y.
8. VR-MVR -10081 -ATT03 -Supportive Dat a for VR -MVR -10081 –Roles and
Responsibilities for the Method Validation.
9. VR-SOP-FE-1129 7, Operation and M aintenance of Roche Cobas® a nalyzer.
10. VR-VPL -10034, Installation and Operati onal Qu alification of Roche Cobas ®
Analy zer.
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Page 1511.SUPPORTI VETABLE S
11.1. List of Critical Reagents for the Elecsys SARS-CoV-2 Validation ...............................15
11.2. Clinical Samples for SARS-C oV-2 Positive Donors......................................................15
11.3.Clinical Samples for SARS -CoV -2 Negative Donors ................................ .................... 17
11.1. List of Critic al Reagents for the E lecsys SARS -CoV-2Validation
Reagent Critical Need Source
R1SARS -CoV -2-Ag~biotin, (gray cap), 1 bottle,
16mL: Biotinylated SARS -CoV -2-specific
recombinant antigen (Ecoli)Assay p rimaryreagents Roche Di agnostics
(Indianapolis , IN)
R2 SARS -CoV -2Ag~Ru (bpy)
(blackcap),
1bottle, 16mL: S ARS -CoV-2- specific
recombinant ant igen labeled with ruthenium
complexAssay secondary r eagents Roche Diagnostics
(Indianap olis, IN)
ACOV2 Cal1 Negativ e calib rator1 (wh itecap),
1bottle of 0.67 mL:Hum an serum , non -reactive
for anti-SARS -CoV -2 antibodiesLow assay calib rator Roche Di agno stics
(Indianapolis , IN)
ACOV2 Cal2 Positiv e calibra tor2 (black cap),
1bottle of 0.67 mL: Human serum, react ive fo r
anti-SARS -CoV -2 antibodies; buffer; preservativeHigh assay calib rator Roche Di agnostics
(Indianapolis,IN)
Custom Positive Control Positi ve Control
Custom Negative Control Negative Control
Serum from SAR S-CoV -2 positive dono rs Clinica l
Specifici ty/Specificity
Experim ents
Serumfrom SARS -CoV -2nega tive donors Clinical
Sensitivit y/Specificity
Experime nts
11.2. Clinica lSample sfor SARS- CoV -2 Positive Donors
Sam ple
NumberID Sample
NumberID Sam ple
NumberID Sample
Numbe rID
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Page 1611.2. Clinica lSample sfor SARS- CoV -2 Positive Donors
Sam ple
NumberID Sample
NumberID Sam ple
NumberID Sample
Numbe rID
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Page 1711.3. C linical Sam ples for SARS -CoV -2 Negativ e Donors
Sample
NumberID Sample
NumberID Sample
Num berID Sample
NumberID
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Document Approval Record
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