Alinity s Anti-HCV II - Clinical Evaluation Protocol
Phase: NA
Conditions: Healthy
Sponsor: Abbott Transfusion Medicine

Protocol No. T3M3-02-19H04-01  
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Abbott Laboratories 
Alinity s Anti-HCV II – Clinical Evaluation Protocol 
 
 
WARNING:   
 
FOR PERFORMANCE EVALUATION ONLY  
 
FOR INVESTIGATIONAL USE ONLY. The performance characteristics of this 
product have not been established. No clinical decision or patient notification should be 
made based on the results obtained with this product. 
 
Protocol No.:   
T3M3-02-19H04-01  
 
Version: 
1   
Date: 
November 16, 2020  
 
 
 
Abbott Monitors: 
 
Tuan L. Bui       
 
John Birdsall  
Clinical Research Manager 
Senior Clinical Research Associate 
Phone: +1 224.668.4702 
 Phone: +1 224.668.2276        
e-mail: tuan.l.bui@abbott.com 
e-mail: john.birdsall@abbott.com       
 
Serena Mezzar       
 
 
Clinical Research Associate 
 
Phone: +1 224.668.4628 
      
e-mail: serena.mezzar@abbott.com 
        
 
  
 
 
Address 
Abbott Laboratories  
 
 
 
 
for all monitors:  
T3M3, CP1 
 
 
 
 
 
 
 
 
100 Abbott Park Road 
 
 
 
 
 
 
Abbott Park, Illinois 60064-6070  
 
 
 
Part or all of the information in this protocol may be unpublished material. Accordingly, 
this protocol is to be treated as confidential, and restricted to its intended use. If any 
portion of this unpublished material is desired for purposes of publication, authorization 
is to be obtained from Abbott Laboratories. 
 
 
 
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Protocol No. T3M3-02-19H04-01  
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Table of Contents  
 
 
Introduction ................................................................................................................... 4 
 
Objectives ...................................................................................................................... 4 
 Study Design ................................................................................................................. 4 
A. Overview ................................................................................................................. 4 
1. Reproducibility .................................................................................................. 5 
2. Specimen Testing .............................................................................................. 5 
B. Ethics ....................................................................................................................... 5 
C. General Schedule of Events ..................................................................................... 6 
D. Comparator Method ................................................................................................. 7 
E. Supplemental Testing .............................................................................................. 7 
F. Follow-up Specimens .............................................................................................. 8 
 Operating Conditions ..................................................................................................... 8 
A. Material and Equipment .......................................................................................... 8 
1. Product Description ........................................................................................... 8 
2. Product Storage and Handling Requirements .................................................... 9 
3. Instructions for Use ........................................................................................... 9 
B. Environment ............................................................................................................ 9 
C. Testing Personnel Requirements ............................................................................. 9 
 
Product Accountability ................................................................................................ 10 
 Study Methods and Procedures ................................................................................... 10 
A. Specimen Selection ............................................................................................... 10 
1. Study Population/Sample Size ........................................................................ 10 
2. Inclusion and Exclusion Criteria ..................................................................... 10 
3. Specimen Handling, Storage, and Accountability ........................................... 11 
B. General Study Procedures ..................................................................................... 12 
1. Assay Installation and Configuration .............................................................. 12 
2. Instrument System General Procedures ........................................................... 12 
3. Assay Calibration ............................................................................................ 12 
4. Assay Training ................................................................................................. 13 
5. Quality Control Validity Criteria ..................................................................... 13 
6. Troubleshooting Quality Controls ................................................................... 13 
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7. Method for Handling Retests, Exceptions, and Dilutions ............................... 14 
8. Additional Troubleshooting ............................................................................. 14 
C. Testing Procedures ................................................................................................ 14 
1. Reproducibility ................................................................................................ 14 
2. Specimen Testing ............................................................................................ 15 
 Methods for Data Collection and Documentation ....................................................... 17 
A. Instrument Data Capture ........................................................................................ 17 
B. Case Report Forms ................................................................................................ 17 
C. Supplemental Data Transfer .................................................................................. 18 
 Adverse Events ............................................................................................................ 18 
A. Device Adverse Event ........................................................................................... 18 
B. Subject Adverse Event .......................................................................................... 18 
 Statistical Procedures ................................................................................................... 19 
A. General Information .............................................................................................. 19 
B. Statistical Analysis Description ............................................................................. 20 
1. Reproducibility ................................................................................................ 20 
2. Clinical Specimens .......................................................................................... 22 
 
Conduct of the Study ................................................................................................... 25 
A. Responsibilities for Conduct of the Study ............................................................. 25 
B. Withdrawal from Study ......................................................................................... 26 
C. Protocol Amendments ........................................................................................... 26 
D. Protocol Deviations ............................................................................................... 26 
E. Incident Reports ..................................................................................................... 26 
F. Discontinuation of the Study ................................................................................. 27 
G. Site File/Record Storage ........................................................................................ 27 
H. Clinical Site Data ................................................................................................... 27 
I. Correspondence ..................................................................................................... 27 
 References ................................................................................................................... 27 
XII. Investigator’s Agreement ............................................................................................ 28 
Appendix 1 ........................................................................................................................... 29 
 
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 Introduction 
This protocol is for the evaluation of the Alinity s Anti-HCV II investigational assay 
using the Alinity s System.  
The Alinity s Anti-HCV II assay is a chemiluminescent microparticle immunoassay 
(CMIA) used for the qualitative detection of antibody to hepatitis C virus (HCV) in 
human serum and plasma specimens on the Alinity s System. The Alinity s Anti-HCV II 
assay is intended to screen individual human donors, including volunteer donors of whole 
blood and blood components, and other living donors for the presence of anti-HCV.   
The performance of the Alinity s Anti-HCV II assay will be evaluated by performing 
reproducibility, specificity, and sensitivity testing of the Alinity s Anti-HCV II assay as 
described in the Testing Procedure section of this protocol. 
The Abbott monitor will provide the Alinity s Anti-HCV II Reagent Kit Clinical 
Brochure, which contains the relevant referenced literature, applicable technology, and 
summary of any known and potential risks and benefits to humans. Clinical brochures 
will also be provided for the Alinity s Anti-HCV II Calibrator Kit, the Alinity s Anti-
HCV II Assay Control Kit, and the Alinity s Anti-HCV II Release Control Kit. 
This study will be conducted in compliance with this protocol, Good Clinical Practice 
(GCP), and the applicable regulatory requirements. 
 
 Objectives 
The objective of this study is to demonstrate the performance and intended use of the 
Alinity s Anti-HCV II investigational assay in a donor screening environment using 
clinical samples to evaluate assay performance. The Alinity s Anti-HCV II assay 
performance will be evaluated utilizing the Food and Drug Administration (FDA) 
licensed Alinity s Anti-HCV assay as the comparator method. The data will be used to 
support regulatory submissions and/or publications. 
 
 Study Design 
A. Overview 
Protocol directed testing will be performed at a minimum of 3 external clinical sites to 
evaluate reproducibility, specificity, and sensitivity of the investigational Alinity s Anti-
HCV II assay in the donor screening centers. Specificity specimens will be provided by a 
minimum of 3 volunteer blood donor centers and 1 plasmapheresis center. Sensitivity 
specimens and panels will be provided by Abbott. A minimum of 3 lots of Alinity s Anti-
HCV II investigational assay reagents, calibrators, and controls will be used throughout 
the study.  
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The clinical sites will provide random leftover donor specimens that are collected as part 
of the routine blood or plasmapheresis donation process to evaluate assay specificity. A 
minimum of 15,000 random unique donor specimens collected across a minimum of 3 
volunteer blood donor centers and 1 plasmapheresis center will be evaluated. At the time 
of collection, the donor will be informed that the donor center may use their donation for 
research studies. Donors will be provided an information sheet explaining this process. 
The donor may also be asked to return and participate in a follow-up blood collection 
based on results obtained. The donor will sign a separate research informed consent form 
for the follow-up blood collection and have approximately 20 to 60 mL of blood drawn 
for testing. 
To evaluate sensitivity, Abbott will provide a minimum of 400 frozen samples from U.S. 
individuals characterized as HCV positive and a minimum of 400 frozen specimens from 
U.S. individuals at increased risk for HCV infection. The specimens will be designated by 
the Abbott monitor.  
All specimens will be identified using a sample identification number (SID).   
1. Reproducibility 
Abbott will provide reproducibility panel members that will be randomized during 
testing. Reproducibility will be performed in two runs per day on each of 5 non-
consecutive days with a minimum of 1 break of 1 day with a minimum of 3 lots of Alinity 
s Anti-HCV II reagents, calibrators, and controls at a minimum of 3 clinical sites. 
2. Specimen Testing 
To evaluate specificity for the Alinity s Anti-HCV II assay, the donor centers will provide 
leftover specimens from the following: 
 
• Volunteer blood donors (EDTA plasma or serum) 
• Plasmapheresis donors. 
To evaluate sensitivity for the Alinity s Anti-HCV II assay, Abbott will provide frozen 
preselected anti-HCV positive specimens from U.S. individuals and specimens from U.S. 
individuals at increased risk for HCV infection. These specimens were prospectively 
collected under separate protocols and are not individually identifiable.   
B. Ethics 
The protocol will be reviewed by the Institutional Review Board (IRB) as part of study 
oversight. 
The clinical sites will provide leftover specimens that will be collected as part of the 
routine blood donation process. The blood donor will be informed that the donor center 
may use their donation for research studies. The blood donor will review an IRB-
approved study information sheet as part of the consent process. The information sheet 
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indicates that by consenting to donate blood or plasma their sample may also be used in 
research studies. 
If results of the investigational assay do not agree with the final specimen status based on 
supplemental testing, the donor may be asked to provide a follow-up sample. For these 
individuals providing follow-up samples, their consent to participate must be documented 
on an IRB-approved informed consent form prior to the collection of the follow-up 
specimen. 
The frozen specimens provided by Abbott were obtained prospectively under separate 
protocols and are not individually identifiable. The specimens will be identified by SID, 
and the clinical sites will have no access to subject data. The clinical sites will be blinded 
from knowledge of the specimen categories for specimens provided by Abbott. All 
specimens obtained prospectively were collected using IRB/IEC (Independent Ethics 
Committee)-approved specimen collection protocols and informed consent forms that 
comprehend the testing of these specimens as outlined in this protocol. These specimen 
collection studies were either sponsored by Abbott or by specimen collection vendors. 
Refer to the Section VI.A.1 Study Population/Sample Size. 
Specimens that are identified as “leftover” or “waste”, are not individually identifiable 
and were obtained according to the FDA Guidance on Informed Consent for In Vitro 
Diagnostic Device Studies using Leftover Human Specimens that are not Individually 
Identifiable, April 25, 2006, or specimens were obtained according to applicable laws and 
guidance regarding informed consent and the use of leftover human specimens. The 
unidentified specimens are used when scientific value is based on characterization of the 
sample rather than the subject’s medical history. 
Until the clinical study is completed, the Investigator will advise their IRB of the progress 
of this clinical study, per IRB requirements. Written approval must be obtained from the 
IRB annually (or more frequently if required by the IRB) to continue the clinical study, 
according to each institution’s IRB requirements. Further, any change to the protocol, 
study information sheet, or informed consent form will be submitted to the IRB and 
written IRB approval must be obtained prior to implementation of change, according to 
each institution’s IRB. 
All reports transferred to and communications with Abbott which pertain to specimens in 
the study must identify each specimen by a SID to ensure subject confidentiality and 
documentation. 
C. General Schedule of Events 
The clinical sites will configure and calibrate the investigational Alinity s Anti-HCV II 
assay on the Alinity s System. 
Testing personnel will be required to demonstrate acceptable performance with the 
investigational assay prior to beginning reproducibility or specimen testing. The Abbott 
monitor will provide the samples for this testing. This testing is not a part of the clinical 
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evaluation. It is used for training and to confirm the clinical site’s ability to perform the 
assay. 
After successful completion of training, testing personnel will perform reproducibility 
and specimen testing using the investigational Alinity s Anti-HCV II Reagent Kit, 
Calibrator Kit, Assay Control Kit and Release Control Kit Clinical Brochures and the 
procedures as described in this protocol. 
Case Report Forms (CRFs) will be utilized to document completion of the test 
procedures. The Abbott monitor will review the data and CRFs to assure compliance to 
the study-directed procedures and to monitor the progress of the study. 
The study will take up to approximately 4-5 months to complete. 
D. Comparator Method 
Each donor specimen and each frozen specimen will be tested using the FDA-licensed 
Alinity s Anti-HCV assay as the comparator. Testing will be performed at a minimum of 
3 clinical sites. Testing will be performed following the Instructions for Use (IFU) and 
will include retesting, where required. 
The comparator assay results will be compared to the corresponding results of the 
investigational assay. 
E. Supplemental Testing 
HCV nucleic acid testing (NAT) results for each of the donor specimens will be provided 
to Abbott to further characterize the donor specimens. 
Specimens from donors and U.S. individuals at increased risk for HCV infection that are 
repeatedly reactive by the Alinity s Anti-HCV II assay and/or the comparator method will 
be further tested using FDA-licensed assays or research use only methods. This 
supplemental testing will be performed either at the clinical sites or at external reference 
laboratories. Results obtained from this testing will be used to better characterize the 
specimen and assess final status. 
The detailed algorithms for supplemental testing are provided in Appendix 1 of this 
protocol. Supplemental testing will be performed per the algorithms and if a specific 
assay is no longer commercially available or changes occur in the clinical site or 
reference laboratory’s routine procedure, a revised version of the clinical protocol will be 
supplied to the sites. Additional testing may be performed based on the clinical site’s 
internal supplemental testing procedures.  Data generated will be provided to Abbott and 
will be used for informational or investigational purposes. 
Preselected HCV positive specimens will have documented positive results prior to 
testing at the clinical sites. Supplemental testing is not required but may be requested by 
the monitor for troubleshooting purposes.  
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F. Follow-up Specimens 
For donor specimens with investigational Alinity s Anti-HCV II results that are 
discordant with final status after supplemental testing, an attempt will be made to obtain a 
follow-up specimen approximately 4 to 6 weeks after initial donation for further analysis. 
The subject will sign a study-specific informed consent form for collection of the 
additional specimen. The follow-up specimen will be tested by the investigational Alinity 
s Anti-HCV II assay, the comparator method, and supplemental testing as required. 
The follow-up result will be used to better characterize the initial donation and may be 
used to indicate seroconversion (or rule out seroconversion).  If seroconversion occurs 
and the follow-up results are repeatedly reactive for comparator assay and positive on 
supplemental testing, the status for that donor will be considered positive and the index 
sample results will be removed from the specificity calculation. 
In case of a positive result with the investigational Alinity s Anti-HCV II assay, each 
clinical site will perform donor management according to their internal procedures. 
 
 Operating Conditions   
A. Material and Equipment 
1. Product Description 
All investigational products, supplies, and materials will be supplied by Abbott 
Laboratories. 
The investigational products for use in this study are as follows: 
• Alinity s Anti-HCV II Investigational Use Only Assay File, List No. 8100/04W56-5A 
• Alinity s Anti-HCV II Reagent Kit, List No. 8100/04W56-60 
• Alinity s Anti-HCV II Calibrator Kit, List No. 8100/04W56-03 
• Alinity s Anti-HCV II Assay Control Kit, List No. 8100/04W56-20 
• Alinity s Anti-HCV II Release Control Kit, List No. 8100/04W56-24 
 
Additional materials provided by Abbott: 
• Training panels 
• Reproducibility panels  
 
A description of the investigational products required to run the Alinity s Anti-HCV II 
assay is presented in the respective Clinical Brochures. 
Expired material(s) must not be used. 
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All materials for the operation of the comparator assay must be used within the expiration 
dates defined by the manufacturer’s instructions. 
2. Product Storage and Handling Requirements 
Storage instructions for the investigational reagent, calibrator, and controls are provided 
in the Alinity s Anti-HCV II clinical brochures. Secured storage of these supplies with 
appropriately restricted access is required. 
The Alinity s accessories, consumables, and disposables must be stored as indicated on 
the product label or packaging. 
Abbott Laboratories will provide the clinical sites with training panels and reproducibility 
panels. The panels will be shipped frozen and must remain frozen at -20°C or below upon 
receipt or will be shipped on wet ice and upon receipt stored at 2-8°C. Refer to the 
“Specimen Collection and Preparation for Analysis” section of the Alinity s Anti-HCV II 
Reagent Kit Clinical Brochure for storage and handling requirements. 
All commercially available products will be handled according to the manufacturer’s 
package insert instructions. 
3. Instructions for Use 
Testing on the Alinity s System for this study will utilize system software version 2.7.0 or 
higher. The clinical sites will operate the Alinity s System in accordance with the Alinity 
s System Operations Manual and the clinical protocol. Instructions for Use can be found 
in the Alinity s System Operations Manual and in the Alinity s Anti-HCV II clinical 
brochures.  
All versions of the Alinity s Anti-HCV II clinical brochures used and a copy of the 
comparator method IFU used in this study will be retained in the Abbott clinical study 
files. 
B. Environment 
Testing of the Alinity s Anti-HCV II assay will be performed at a minimum of 3 external 
donor testing facilities. Testing sites that test specimens from blood donor collections 
may also test specimens from plasmapheresis collections.  
C. Testing Personnel Requirements 
Personnel involved in executing the study must be trained on or have documented 
experience operating and maintaining the Alinity s System. Each individual will also be 
trained on the protocol and Alinity s Anti-HCV II clinical brochures and will be required 
to demonstrate acceptable performance with the investigational assay prior to beginning 
Testing Procedures described in this protocol. 
 
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 Product Accountability 
The clinical sites must maintain records and accountability documentation of the receipt 
dates, lot numbers, quantities, and the use, destruction and/or return of all investigational 
products and comparator products, if provided by Abbott. The Abbott monitor will 
periodically verify the accuracy of these inventories. 
All investigational products must be returned to Abbott or disposed of on-site. An 
investigator will not supply investigational products to any individual who is not named 
as a study investigator. 
 
 Study Methods and Procedures 
A. Specimen Selection 
1. Study Population/Sample Size 
A minimum of 400 preselected Anti-HCV positive specimens from U.S. individuals will 
be provided by Abbott and distributed across a minimum of 3 clinical sites for sensitivity 
testing with the investigational Alinity s Anti-HCV II assay and the comparator assay. 
These specimens were obtained from U.S. individuals with a positive anti-HCV result or 
diagnosed as chronic or acute hepatitis C infection. Specimens will be shipped and stored 
frozen at -20°C or below prior to testing. 
A minimum of 400 specimens from U.S. individuals at increased risk for HCV infection 
will be provided by Abbott and distributed across a minimum of 3 clinical sites for testing 
with the investigational Alinity s Anti-HCV II assay and the comparator assay. Risk 
factors for these individuals have been obtained along with age, gender and race, where 
available. Specimens will be shipped and stored frozen at -20°C or below prior to testing. 
A minimum of 15,000 unique specimens will be used for specificity testing across a 
minimum of 3 clinical sites. Of these 15,000 specimens, at least 12,000 will be serum or 
EDTA plasma collected across a minimum of 3 volunteer blood donor centers and at least 
3,000 will be source plasma collected at 1 plasmapheresis center. At least one third 
(4,000) of total volunteer blood donors will be EDTA plasma specimens and at least one 
third (4,000) will be serum specimens. Leftover specimens with sufficient residual 
volume of either serum or plasma will be tested on the investigational Alinity s Anti-HCV 
II assay and comparator assay. No demographic information will be collected from these 
blood donors. 
2. Inclusion and Exclusion Criteria 
Subjects must have reviewed the information sheet and, if applicable, must have signed 
and dated the informed consent form for follow-up specimen collection. Additionally, 
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subjects must have met the inclusion and none of the exclusion criteria as follows to be 
eligible for participation in this study: 
Inclusion Criteria 
• 
Serum or EDTA plasma from a blood donor, or plasma from a plasmapheresis donor. 
Exclusion Criteria 
• 
Previous participation in this study. Each subject must be represented only once in the 
study. 
Frozen samples provided by Abbott have no specific inclusion/exclusion criteria that the 
clinical sites need to verify prior to testing. 
3. Specimen Handling, Storage, and Accountability 
Donor specimens will be handled according to the facility’s policies and procedures for 
collecting and storing specimens. Specimens obtained from blood donations are residual 
or leftover collected in either serum or EDTA plasma collection tubes. Specimens 
obtained from plasmapheresis donations are representative of the citrated plasma from the 
donation. Each specimen is to be tested using the unique SID. 
Follow-up specimens from donors will be collected via routine venipuncture into EDTA 
plasma and/or serum tubes according to the site’s routine collection procedures. Specimen 
volume will be approximately 20-60 mL. Specimen centrifugation will be done following 
the requirements of the comparator assay IFU and the requirements of the investigational 
Alinity s Anti-HCV II Reagent Kit Clinical Brochure. After testing with the 
investigational assay and comparator assay, the remaining specimen volume should be 
stored frozen at -20°C or below. The Abbott monitor will provide details of any 
supplemental testing needed. 
For frozen specimens, Abbott has documentation for collection, processing, and storage 
of clinical specimens from the vendors. Frozen specimens will be shipped to the clinical 
sites and must be stored frozen at -20°C or below until tested. All frozen aliquots must be 
handled and stored at the clinical sites as described in the Alinity s Anti-HCV II Reagent 
Kit Clinical Brochure. Testing with the investigational assay will be performed using 
specimens subjected to the same number of freeze/thaw cycles (one thaw cycle) as the 
comparator method. Sample aliquots used for testing on the comparator method must be 
handled or processed per the comparator method IFU. If a specimen is thawed and 
refrozen prior to testing or retesting, the occurrence must be documented on an Incident 
CRF and the Abbott monitor notified. 
The clinical sites must maintain records (e.g., packing slips) of the delivery and receipt of 
each shipment, as well as document the condition of the clinical specimens upon arrival 
and the location where the specimens are being stored. Specimen accountability 
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documentation must be maintained by the clinical sites to document the use and 
destruction and/or return of specimens. 
Specimens may be shipped to Abbott Laboratories for additional testing or to a reference 
laboratory for supplemental testing as directed by the Abbott monitor. Specimens must be 
stored at -20°C or below and shipped overnight on dry ice. When shipped, specimens 
must be packaged and labeled in compliance with applicable state, federal, and 
international regulations governing the transport of clinical specimens and infectious 
substances. 
A specimen may be removed from the study if the sample is found unacceptable for 
testing (e.g., inappropriate handling prior to testing, inadequate volume), or for other 
assignable causes. The reason for removal must be documented on an Incident CRF. 
Specimens removed from the study may need to be replaced, if deemed necessary by the 
Abbott monitor, to meet requirements for the minimum number of specimens. 
B. General Study Procedures 
1. Assay Installation and Configuration 
The investigational Alinity s assay software is installed onto the Alinity s System prior to 
starting study-directed testing. The monitor will provide instructions on software 
configuration needed to start the study. 
2. Instrument System General Procedures 
Maintenance procedures are to be performed as instructed in the Alinity s System 
Operations Manual. Reports for maintenance and any documentation for component 
replacements that occurred during the study must be filed in the study records. 
The on-board inventory of the Alinity s System supplies and reagents will be checked 
daily. Load consumables and update inventory as necessary.   
Refer to the Alinity s System Operations Manual. 
3. Assay Calibration 
The Alinity s Anti-HCV II assay will be calibrated as described in the Alinity s Anti-
HCV II Reagent Kit Clinical Brochure and the Alinity s Anti-HCV II Calibrator Kit 
Clinical Brochure. The calibrator lot number and expiration date information will be read 
from barcodes when the material is tested on the instrument system. Refer to the 
“Calibration Procedures” Section of the Alinity s System Operations Manual. 
Calibration is to be performed for each investigational Alinity s Anti-HCV II reagent lot. 
Print to USB and transfer electronic report of the calibration and control results for each 
reagent lot tested. Refer to the Alinity s Anti-HCV II Reagent Kit Clinical Brochure and 
the Alinity s Anti-HCV II Calibrator Kit Clinical Brochure for frequency of calibrations. 
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Refer to the Alinity s Anti-HCV II Assay Control Kit Clinical Brochure to determine 
acceptability of the quality control results used during calibration. If unexpected results 
are obtained or problems are encountered, contact the Abbott monitor. 
4. Assay Training 
The study staff will have documented training in the operation of the Alinity s System 
prior to performing protocol directed activities.  
Training materials (e.g., training panel) will be used to assess proficiency of the user 
performing the investigational Alinity s Anti-HCV II assay. Assay training is to be 
performed by each user for the investigational Alinity s Anti-HCV II assay. Testing will 
be performed as described in a separate workflow document. The Abbott monitor will 
evaluate the results for acceptability. 
5. Quality Control Validity Criteria 
Daily quality controls for the investigational Alinity s Anti-HCV II assay will be tested a 
minimum of once each day, on each reagent lot tested for that day. 
Refer to the Alinity s System Operations Manual for testing of the quality controls. 
Daily quality controls for the investigational Alinity s Anti-HCV II assay will be assessed 
for validity using the ranges described in the Alinity s Anti-HCV II Assay Control Kit 
Clinical Brochure. 
6. Troubleshooting Quality Controls  
The following steps must be used when troubleshooting and documenting quality control 
failures. 
1) Determine if an assignable cause can be found (e.g., incorrect placement, bubbles). If 
an assignable cause can be found, correct the identified problem. 
2) Retest the quality control from the original control bottle. If the quality controls are 
within the validity criteria, testing may continue. 
3) If the quality control value still does not meet the validity criteria, test the quality 
control substituting a new control bottle. If the quality control value is within the 
established range, continue testing. 
4) If the quality control value still does not meet the validity criteria, repeat assay 
calibration on the instrument and repeat all quality controls. If the quality control 
values are within the established range, continue testing. 
5) If the quality control value still does not meet the validity criteria, place new reagents 
on the instrument, repeat assay calibration, and repeat all quality control testing. If 
the controls are within the validity criteria, testing may continue. 
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Do not discard any reagents, calibrators, or controls that may have caused the out of 
range results. 
6) If the quality control value still does not meet the validity criteria, contact the Abbott 
monitor for further instruction. Any test results generated since the last acceptable control 
run must be evaluated to determine if test results may have been adversely affected. 
An Incident CRF must be completed, documenting the troubleshooting steps performed 
and any additional action required for resolution (e.g., recalibration, opening a new 
control bottle). The Abbott monitor must be notified when control failures are 
observed. 
7. Method for Handling Retests, Exceptions, and Dilutions 
The following conditions may require retesting: 
• Specimens with initial S/CO values ≥ 1.00 are initially reactive and must be retested 
in duplicate. Specimens with an initial Alinity s Anti-HCV II S/CO result ≥ 0.80 to < 
1.00 should be removed from the clot and stored frozen (-20°C or colder). 
• Testing of a specimen may be repeated if assignable cause (e.g., operator error, 
instrument malfunction) can be determined and documented by the clinical site. 
• 
For tests that cannot be completed and result in an error code, the test is to be 
repeated. If unable to retest the specimen or additional troubleshooting steps are 
required to resolve the error, an Incident CRF must be completed. A copy of the error 
report or screen display should be printed and electronically transferred, when possible. 
The original SID will be used for all repeat testing. Refer to the “Specimen Collection 
and Preparation for Analysis” Section of the Alinity s Anti-HCV II Reagent Kit 
Clinical Brochure. If re-centrifugation is required, document using an Incident CRF. 
8. Additional Troubleshooting 
The Abbott monitor may request certain procedures or additional testing to be performed 
for troubleshooting purposes. The additional testing may require various procedures be 
repeated. 
C. Testing Procedures  
The clinical site testing is to be performed according to the clinical protocol and the 
appropriate sections of the Alinity s Anti-HCV II clinical brochures. 
1. Reproducibility  
Alinity s Anti-HCV II reproducibility testing will be performed at a minimum of 3 
clinical sites using a minimum of 3 lots of Alinity s Anti-HCV II reagents, calibrators, 
and controls. 
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Testing will include two runs per day on each of 5 non-consecutive days with a 
minimum of 1 break of 1 day per site per lot. Each reproducibility run will include four 
replicates tested for each reproducibility panel member. 
Procedure 
1) Test the Alinity s Anti-HCV II Assay Control (Negative and Positive), if daily quality 
controls have not been already tested and assessed for validity. 
2) Refer to the “Specimen Collection and Preparation for Analysis” section of the 
Alinity s Anti-HCV II Reagent Kit Clinical Brochure for detailed procedures on handling 
of samples prior to placing the reproducibility panel members on the Alinity s System. 
3) Place the barcoded sample tubes in a sample rack as directed by the Abbott monitor. 
4) Schedule the Alinity s Release Control. If the release control is not already on the 
system, place the calibrator and control rack on the Alinity s System in the priority bay to 
schedule testing. 
5) Testing as described in Steps 1 through 4 will be performed on each of five days. 
Note: If an error occurs during reproducibility testing, reproducibility testing for that 
day may need to be repeated. Errors which occur during reproducibility testing must be 
documented on an Incident CRF and the Abbott monitor must be informed. 
2. Specimen Testing 
Testing will be performed to determine the agreement of specimen results obtained from 
the Alinity s Anti-HCV II assay to the comparator method. Testing of the comparator 
method will be performed according to the comparator IFU. 
Each of the donor centers will provide specimens from random donors representing 
unique individuals for a total of minimum 15,000 donor specimens. Volunteer blood 
donor specimens will be provided by a minimum of 3 blood donor centers and specimens 
from plasmapheresis donors will be provided by 1 plasmapheresis center. The specimens 
will be tested across a minimum of 3 clinical sites and across a minimum of 3 lots each of 
Alinity s Anti-HCV II reagents, calibrators, assay controls and release controls, as 
instructed by the clinical monitor. The results for the Alinity s Anti-HCV and NAT assay 
will be provided to Abbott for each donor specimen. Testing of any follow-up donor 
specimens will be done using the procedure below for the investigational Alinity s Anti-
HCV II assay, comparator assay, and supplemental testing, as needed.  
A minimum of 400 frozen preselected Anti-HCV positive specimens from U.S. 
individuals and a minimum of 400 frozen specimens from U.S. individuals at increased 
risk for HCV infection will be provided by Abbott and distributed across 3 clinical sites 
for sensitivity testing. Specimens will be tested across a minimum of 3 lots of 
investigational Alinity s Anti-HCV II reagents, calibrators, and controls. In addition, the 
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specimens will be tested on the corresponding Alinity s Anti-HCV comparator method. 
The Abbott monitor will provide the details of which specimens to test as well as the 
investigational Anti-HCV II reagent/calibrator/control lot combination, if required. 
Note: After testing of a specimen, any remaining specimen volume must be retained 
frozen (at -20°C or colder). The Abbott monitor may request certain procedures or 
additional testing to be performed for troubleshooting purposes. The additional testing 
may require various procedures to be repeated. 
Note: Specimens must be tested on the same freeze thaw cycle for the Alinity s assay 
and the comparator method. If the sample has been tested or retested on a subsequent 
freeze thaw cycle, the event must be documented on an Incident CRF and the Abbott 
monitor notified. 
Procedure 
1) Test each Alinity s Anti-HCV II quality control, if daily Alinity s quality controls 
have not been already tested and assessed for validity. 
2) Refer to the “Specimen Collection and Preparation for Analysis” section of the 
Alinity s Anti-HCV II Reagent Kit Clinical Brochure for detailed procedures on handling 
of samples prior to placing specimens on the Alinity s System. 
3) A single replicate of each specimen must be tested with the investigational Alinity s 
Anti-HCV II assay. Specimens must be placed in barcoded tubes in a sample rack and 
placed on the Alinity s System to schedule testing. 
4) Schedule an Alinity s Anti-HCV II Release Control. If the release control is not 
already on the system, place the calibrator and control rack on the Alinity s System in the 
priority bay to schedule testing. 
5) Specimens with an initial S/CO result of ≥ 1.00 are initially reactive and should be 
retested in duplicate with the investigational Alinity s Anti-HCV II assay. Specimens with 
an initial S/CO result of < 1.00 do not require further testing. 
6) Repeat testing should be performed using the same reagent lot and be done on the 
same day or the following workday. If greater than 48 hours has elapsed from the initial 
centrifugation, re-centrifuge the sample and document on the Incident CRF. Refer to the 
Alinity s Anti-HCV II Reagent Kit Clinical Brochure for further information regarding 
centrifugation of specimens. 
7) Initially reactive specimens with both duplicate retest results nonreactive (S/CO < 
1.00) are negative and no further testing is required. If either retest result has S/CO > 
1.00, then supplemental testing will be performed. 
8) Each specimen must be tested with the comparator Alinity s Anti-HCV method. 
Specimens with an initial S/CO result of < 1.00 do not require further testing. Specimens 
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with an initial S/CO result of ≥ 1.00 are initially reactive by the comparator method and 
should be retested in duplicate on the same day or on the next work day of testing. If re-
centrifugation is required for the comparator method testing, document on the Incident 
CRF. Refer to the comparator Alinity s Anti-HCV IFU for further information regarding 
centrifugation of specimens. 
9) If the comparator method result is repeatedly reactive, then supplemental testing will 
be performed. 
10) Refer to the protocol Appendix 1 for the Alinity s Anti-HCV II Supplemental 
Algorithms and instructions from your Abbott monitor regarding supplemental testing. 
11) After supplemental testing is complete for donor specimens, the Abbott monitor will 
notify the collection site of any donors that need to be contacted for follow-up blood 
collections. 
 
Note: For other situations where retesting may be required (e.g., error codes) refer to the 
“Method for Handling Retests, Exceptions, and Dilutions” section of this protocol. 
 
 
Methods for Data Collection and Documentation 
A. Instrument Data Capture 
In addition to the required instrument reports, the investigational Alinity s Anti-HCV II 
data and comparator Alinity s Anti-HCV data will be transmitted electronically using an 
approved data capture procedure (e.g., Abbott Link) on a daily or as needed basis. 
If any assay data is not captured by the computer system or via spreadsheet and there is 
no electronic back up of the data, the data will be manually entered into the database at 
Abbott using the original instrument printout. 
B. Case Report Forms 
CRFs will be provided for collection of data including detailed instructions for 
completion of these forms. 
CRF data or information related to the study will be recorded electronically using a web-
based system. Site personnel responsible for entering data will be trained on the use of the 
electronic system (i.e., access, entry and submission of data). Data entered by the clinical 
sites will be reviewed by an Abbott monitor, and queried if needed. Queries must be 
resolved in a timely manner. 
Data or information recorded on the CRF with no prior written or electronic record, (e.g., 
specimen processing, storage date and time) will be considered the source document.  
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The investigator must sign or certify the CRF where indicated. The investigator’s 
signature indicates that the investigator takes responsibility and accountability for the data 
being accurate and complete. Where signatures are required, they must be handwritten or 
captured electronically per 21 CFR Part 11. Stamps for signatures are not allowed. 
At the conclusion of the study, a copy of the completed CRF will be maintained at each 
clinical site. 
C. Supplemental Data Transfer 
The HCV NAT results and supplemental results will be provided to Abbott in a format as 
agreed upon with the clinical monitor. 
 
 
Adverse Events 
No side effects or adverse events are anticipated. In the unexpected event of a serious 
adverse event resulting from use of the investigational device, the Abbott monitor must be 
notified immediately by telephone and subsequently in writing within five (5) days of the 
occurrence. The event must be described on the Adverse Event CRF. All adverse events 
are to be followed to satisfactory resolution, and any measures taken, as well as the 
follow-up, reported on the appropriate CRF.  
A. Device Adverse Event 
A Device Adverse Event is any effect on the health or safety of an individual associated 
with the use of a product which has or may have caused or contributed to an injury, a 
system malfunction or user error resulting in personal injury (e.g., electrical shocks, 
burns), or exposure to potentially hazardous material (e.g., chemical or biohazardous), or 
a fire or visible smoke that was not self-contained to the system and caused damage 
outside of the system. 
A Device Serious Adverse Event is an adverse event that has or may have caused or 
contributed to a death or serious injury of an individual or an adverse event resulting from 
malfunction that could cause or contribute to a death or serious injury if the malfunction 
were to recur. A serious injury includes a life-threatening illness or injury, an illness or 
injury which results in permanent impairment of a body function or permanent, 
irreversible damage to body structure, or a condition, an injury or illness necessitating a 
medical or surgical intervention by a health care professional to prevent permanent, 
irreversible impairment of a body function, or damage to a body structure. 
B. Subject Adverse Event 
Donor specimens used in the study are collected as part of the routine blood donation 
process. Events related to the blood donation process will be handled according to the 
donor center procedures and not recorded in the study files. 
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For donor follow-up specimens collected under this protocol, subject adverse events will 
be documented if they occur. All subject adverse events must be described on the 
Adverse Event CRF and source document. All subject adverse events are to be followed 
to satisfactory resolution, and any measures taken, as well as the follow-up, reported on 
the appropriate CRF and source document. It is expected that drawing blood or plasma 
may cause pain, bruising, lightheadedness, and on rare occasion, infection at the site of 
the blood draw. These events will not be recorded as adverse events as they are 
considered to be normal events that may occur during the course of a blood draw. Other 
events that may occur such as fainting, that are not routinely associated with a blood 
draw, must be recorded on the Adverse Event CRF and be followed to satisfactory 
resolution. 
A Subject Adverse Event is any unfavorable or unintended medical occurrence (e.g., 
sign, symptom, or disease) temporally associated with the specimen collection procedure 
performed. 
A Subject Serious Adverse Event is an untoward medical occurrence that: 
• results in death 
• is life-threatening 
• requires inpatient hospitalization or prolongation of existing hospitalization 
• results in persistent or significant disability/incapacity, or 
• results in a congenital anomaly/birth defect. 
 
 Statistical Procedures 
A. General Information 
Data analyses will be performed, and tables and listings of data will be provided by ADD 
Global Statistical Affairs using SAS version 9.3 or higher, R version 3.4 or higher and/or 
WPS version 4.0 or higher.  
If revised or additional analyses are required, a description of the additional or revised 
analyses and justifications for the changes will be documented.  
The Abbott monitor will review all test results and may request that certain observations 
be excluded from analysis if there is an assignable cause, i.e., control or validity criteria 
failure, instrument errors or problems, acknowledged technologist error, and/or 
noncompliance with the study protocol. All results tested according to the protocol and 
not excluded will be eligible for analysis. 
The statistical analysis output along with a listing containing each observation collected 
for this study will be completed. The listing will be provided for data included in the 
analysis and excluded from the analysis. The excluded listing will include the reasons for 
exclusion. A summary of the usage of every test result will also be completed, together 
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with the final analysis results, to ensure that there is no data point missing or misplaced in 
the analysis. 
There is no plan to perform interim analyses that evaluate interim data against acceptance 
criteria. However, interim data monitoring will be conducted to ensure data meet validity 
criteria and minimum sample size requirements.  
B. Statistical Analysis Description 
1. Reproducibility 
a. Study Design 
Assay reproducibility will be determined by testing controls and members of a panel at a 
minimum of 3 clinical sites using a minimum of 3 lots each of Alinity s Anti-HCV II 
assay reagents, calibrators, and controls. 
b. Analysis Variables 
The analysis variable is the Alinity s Anti-HCV II S/CO values for all panel members and 
controls. 
c. Statistical Analysis Method 
The analysis method is based on CLSI EP05-A3. The reproducibility panel members and 
the Negative and Positive controls will be tested twice a day (minimum 2 hours apart 
from the last test result of a sample from the first run to the first test result of the same 
sample from the second run) for a minimum of 5 days per site and per reagent lot. Within 
each run, each panel member/control will be tested in two aliquots and two replicates will 
be assayed per aliquot, resulting in four results per sample. 
Overall Reproducibility Analysis 
Data from all sites and reagent lots for each reproducibility panel/control member will 
be used for the reproducibility analysis. The following individual variance components 
will be estimated: within-run, between-run, between-day, between-lot, between-site, and 
site-lot interaction. The within-laboratory variance is defined as the summation of 
within-run, between-run, and between-day variance components. Reproducibility is 
defined as the summation of within-run, between-run, between-day, between-lot, 
between-site, and site-lot interaction variance components. The estimates of the mean 
S/CO, standard deviation (SD) and %CV will be calculated. 
By Site Analysis 
A similar analysis as overall analysis will be performed by site for each reproducibility 
panel/control member. The within-run, between-run, between-day, and between-lot 
variance components will be estimated. The within-laboratory variance is defined as 
the summation of within-run, between-run, and between-day variance components. 
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Reproducibility is defined as the summation of within-run, between-run, between-day, 
and between-lot variance components. 
By Lot Analysis 
A similar analysis as overall analysis will be performed by reagent lot for each 
reproducibility panel/control member. The within-run, between-run, between-day, and 
between-site variance components will be estimated. The within-laboratory variance is 
defined as the summation of within-run, between-run, and between-day variance 
components. Reproducibility is defined as the summation of within-run, between-run, 
between-day, and between-site variance components. 
Percent Agreement 
A percent agreement and the 95% confidence interval (CI) with the expected results from 
a sample (reactive or nonreactive) will be performed for each panel/control. 
d. Sample Size  
The design of the study is based on CLSI EP05-A3. Each reproducibility panel/control 
member (sample) will be tested twice a day for 5 days in replicates of 4 at a minimum of 
3 clinical sites, using a minimum of 3 reagent lots to obtain approximately 360 replicates 
for each sample (i.e., 4 replicates/run × 2 runs/day × 5 days × 3 clinical sites × 3 lots = 
360 total replicates). 
e. Level of Significance/Confidence Statement 
A 95% CI will be constructed for agreement analysis. 
f. Data Handling Convention 
All results from this testing that are performed according to the protocol and not excluded 
will be eligible for analysis. Reasons for any exclusion will be captured in the database. 
g. Outlier Detection 
The range of data (difference between the maximum and minimum within a run) will be 
calculated by site, lot, day, run, and sample. If the range of the data is greater than 9 times 
the SD using the applicable imprecision from product requirement, investigate and 
identify the run as an outlying run and the run will be repeated for the panel/control. If the 
(5.5 × SD) < (range of the data) < (9 × SD) from the applicable imprecision product 
requirement, investigate and identify the run as an outlying run but do not repeat the run 
for that panel/control.  
The analyses will be performed with the outlying run(s) included and with the outlying 
run(s) excluded. 
 
 
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2. Clinical Specimens 
Clinical specimens will be tested with the Alinity s Anti-HCV II assay, comparator 
method, and supplemental testing as needed to determine final status. 
a. Study Design 
Percent agreement will be calculated between Alinity s Anti-HCV II assay results and the 
comparator method results. Supplemental testing will be performed to determine 
specimen final status, if needed. The sensitivity and specificity will be calculated based 
on specimen final status. For the Alinity s Anti-HCV II and comparator assay, the 
specificity will be calculated using results from donor specimens, a presumed zero 
prevalence population and the sensitivity will be calculated using results from the 
preselected Anti-HCV positive specimens and from the increased risk for HCV infection 
specimens. 
b. Analysis Variables 
• Alinity s Anti-HCV II assay interpretation and the Alinity s Anti-HCV comparator 
assay interpretation 
• Specimen Category 
• Alinity s Anti-HCV II and comparator assay S/CO values 
• Specimen final status 
c. Statistical Analysis Method 
Percent Agreement 
Percent agreement of Alinity s Anti-HCV II assay final results and Alinity s Anti-HCV 
comparator assay final results will be calculated. 
Alinity s Anti-HCV II 
Alinity s Anti-HCV 
Repeatedly Reactive 
Nonreactive 
Repeatedly Reactive 
A 
B 
Nonreactive 
C 
D 
 
Percent Agreement = (A+D) / (A+B+C+D) × 100% 
 
 
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Initial Reactive Rate and Repeat Reactive Rate 
The number and percentage of Alinity s Anti-HCV II initially reactive (IR) donors and 
the number and percentage of Alinity s Anti-HCV II repeatedly reactive (RR) donors will 
be summarized. 
Two-sided 95% confidence intervals will be calculated for initial and repeat reactive rates 
using the exact method based on the binomial distribution. 
IR Rate not Reactive on Retest and RR Rate not Positive by Supplemental Testing  
The number and percentage of Alinity s Anti-HCV II IR donors that are not reactive on 
retest and the number and percentage of RR donors that are not positive by supplemental 
testing will be summarized. 
Two-sided 95% confidence intervals will be calculated for IR Rate not Reactive on Retest 
and RR Rate not Positive by Supplemental Testing using the exact method based on the 
binomial distributions. 
Specificity and Sensitivity 
The following table will be used to calculate Alinity s Anti-HCV II specificity and 
sensitivity based on the specimen final status. 
Alinity s Anti-HCV II 
Final Status 
Positive 
Indeterminate 
Negative 
Repeatedly Reactive 
A 
B 
C 
Nonreactive 
D 
E 
F 
 
Specificity 
The calculation of specificity will include results from volunteer blood donors and 
plasmapheresis donors.  
The specificity is calculated as the proportion of nonreactive (NR) specimens from 
specimens with negative status. 
Specificity = F / (C+F) × 100% 
Specificity can be also calculated as the proportion of NR specimens with negative status 
from specimens with negative status and repeatedly reactive (RR) specimens with 
indeterminate status: 
 
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Specificity = F / (C + B + F) × 100% 
Two-sided 95% confidence intervals will be calculated for specificity using the exact 
method based on the binomial distributions. 
Histogram 
Population distributions for the donor specimens will be presented in histograms and will 
include mean S/CO, standard deviation (SD), and the number of SDs from the mean to 
the cutoff of the nonreactive population.   
Sensitivity 
The evaluation of sensitivity will include result from preselected HCV positive and 
individual at increased risk of HCV infection. 
The sensitivity is calculated as the proportion of RR specimens from specimens with 
positive final status.  
Sensitivity = A / (A+D) × 100% 
Sensitivity can be also calculated as the proportion of RR specimens with positive status 
from specimens with positive status and NR specimens with indeterminate status: 
Sensitivity = A / (A + D + E) × 100% 
A two-sided 95% CI for overall sensitivity will be calculated using the exact method 
based on the binomial distributions.   
d. Sample Size 
Sample size for specificity is maximum of 15,000 and calculated based on the minimum 
power of 80% and α ≤ 0.05. 
Sample size for sensitivity is not determined using statistical power calculations. Sample 
size is determined by the number of available specimens. 
e. Level of Significance/Confidence Statement 
Two-sided 95% CI will be provided. 
f. Data Handling Convention 
All results from this testing that are performed according to the protocol and not excluded 
will be eligible for analysis. Reasons for any exclusion will be captured in the database. 
 
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 Conduct of the Study 
A. Responsibilities for Conduct of the Study 
1) The investigator will have written and dated approval/favorable opinion from the IRB 
for the protocol and other documents as specified by the IRB before initiating the study. 
In some cases, the IRB may provide an expedited or exception review. 
2) The investigator is responsible for reporting to the IRB and obtaining the necessary 
approvals from his/her site administration. 
3) Abbott Laboratories will not initiate the study until the required pre-study documents 
are received from the clinical site. Pre-study documents are aligned with GCP 
requirements and a detailed listing of the required pre-study documents will be provided 
to the investigator by the Abbott monitor. 
4) The investigator will perform the study in accordance with GCP. The Abbott monitor 
will provide the investigator with the GCP-aligned list of investigator requirements. 
5) The Abbott monitor will provide the investigator with the Guidance for Industry 
Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study 
Subjects (October 2009) for reference. 
6) Abbott Laboratories has a responsibility under GCP to monitor this clinical study. The 
Abbott monitor will provide the investigator with the GCP-aligned list of responsibilities 
of the Abbott monitor. 
7) The investigator will maintain a list of appropriately qualified persons to whom he/she 
has delegated significant study-related duties. This list must be updated as needed and the 
Abbott monitor must be notified of the changes.   
8) If informed consent is required by the IRB, the investigator will assure that all 
subjects are provided both written and oral informed consents, and that the subject’s 
consent is documented in accordance with local laws. In addition, every subject will be 
provided a copy of the consent form.  
9) If informed consent is required by the IRB, the investigator will maintain the subject’s 
original consent form in the subject’s permanent medical record or in the investigator’s 
records, depending on site policy. 
 
10)  The investigator agrees to the requirement for guaranteed access to source data and to 
the investigator himself/herself by the IRB, Abbott monitor(s), auditors, and regulatory 
inspectors for the purpose of data verification or correction. 
 
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B. Withdrawal from Study 
A subject’s participation in any clinical study is voluntary and subject has the right to 
withdraw from the study any time without prejudice, however, the request to withdraw 
agreement does not include information that has already been made known or information 
gathered as a result of participation in the study.   
All subjects enrolled in the study must be accounted for and the withdrawal of any 
subjects from the study will be documented on the appropriate CRF. Individuals 
withdrawn from the study may be replaced with another individual that meets the subject 
enrollment criteria. 
C. Protocol Amendments 
All protocol amendments will be written and approved by Abbott Laboratories prior to 
submission for IRB review and approval or exemption. 
The investigator will not implement or deviate from the protocol without agreement from 
Abbott Laboratories and prior review and approval from the IRB. Exceptions to this 
include instances where it is necessary to eliminate an immediate hazard to study 
subjects, or when the protocol changes involve only logistical or administrative aspects of 
the study. 
D. Protocol Deviations 
A protocol deviation is defined as a planned or unplanned departure from the study 
protocol. All protocol deviations that occur during this study will be recorded on the 
Protocol Deviation CRF. 
Planned deviations from this protocol must be reported to the monitor prior to 
implementation. The implemented deviation and the circumstances regarding the 
deviation will be documented on the Protocol Deviation CRF. The monitor will approve 
in writing the inclusion of any specimen, which does not meet all of the inclusion or 
exclusion criteria of the study. The monitor may provide verbal approval prior to the 
written response.  
E. Incident Reports 
An Incident CRF will be used to document any incident(s) that occur during the clinical 
study. An incident is defined as any unplanned or unexpected event that occurs with or 
without the input or intervention of the operator. The Incident CRF must include a 
description of the incident, possible cause (if known), action taken, and identify any 
specimens that were affected. 
 
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F. Discontinuation of the Study 
The study may be terminated prior to the stated time for reasons of safety or efficacy, or 
for other identified causes. The reason for discontinuation will be documented in the 
clinical study master file. 
G. Site File/Record Storage 
The investigator should arrange for the retention of all study documents in the site file. 
The investigator shall retain the site file records for at least a period of 2 years following 
the date a marketing application is approved; or if no application is to be filed or if the 
application is not approved for such an indication, until at least 2 years after the 
investigation is discontinued and the FDA is notified. These documents should be 
retained for a longer period, however, if required by the applicable regulatory 
requirements or by agreement with the sponsor. It is the responsibility of the sponsor to 
inform the investigator/institution when these documents no longer need to be retained. 
H. Clinical Site Data 
At the completion of the study a listing of the clinical site’s data generated during the 
study will be provided to each site. 
I. Correspondence  
All relevant correspondence between the Abbott monitor and the clinical site must be 
documented and retained as part of the study records (i.e. any telephone communication 
with the Abbott monitor should be documented in a telephone log, copies of email 
messages should be printed). 
 
 References 
Alinity s System Operations Manual. 
Clinical and Laboratory Standard Institute. Evaluation of Precision Performance of 
Quantitative Measurement Methods; Approved Guideline – Third Edition, CLSI 
document EP05-A3. Wayne, Pennsylvania: Clinical and Laboratory Standard Institute; 
2014. 
CDRH guidance document. Guidance on Informed Consent for In Vitro Diagnostic 
Device Studies Using Leftover Human Specimens that are Not Individually 
Identifiable, April 25, 2006. 
FDA guidance document. Guidance for Industry Investigator Responsibilities – 
Protecting the Rights, Safety, and Welfare of Study Subjects (October 2009). 
 
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Protocol No. T3M3-02-19H04-01  
Confidential Information 
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Page 28 of 30 
XII. 
Investigator’s Agreement 
 
 By signing this statement, the investigator agrees: 
 
 
1. I have read and understand the contents of the Alinity s Anti-HCV II - Clinical 
Evaluation Protocol (Protocol No. T3M3-02-19H04-01 Version 1), dated November 
16, 2020 and appropriate Alinity s Anti-HCV II clinical brochures and will adhere to 
the study requirements as presented, and applicable local regulations. 
 
2. I will protect the rights, safety, and well-being of subjects. Before initiating the 
study and where required by local regulations, an Institutional Review Board (IRB) 
will review and approve the study protocol and all other applicable study material. A 
copy of the approval of the study protocol will be submitted to Abbott Laboratories. 
 
3. I will not use the results from products labeled as “For Investigational Use Only” 
or “For Performance Evaluation Only” for diagnostic purposes, because the 
performance characteristics of the product have not been established. 
 
4. I understand that Abbott Laboratories, its designees, and regulatory authorities 
may require access to source documents for verification of study data. 
 
5. I understand that if any questions arise, now or during the clinical evaluation, I 
will promptly contact the Abbott monitor or designee at Abbott Laboratories for 
clarification. 
 
Investigator (Printed Name): ____________________________________________ 
 
Investigator Title: ____________________________________________________ 
 
Investigator Signature: __________________________________ Date: _________ 
 
Institution Name: _____________________________________________________ 
   
Institution Address:  ___________________________________________________ 
                         
  
 
  ___________________________________________________ 
 
 
 
___________________________________________________ 
 
 
D000096563 Rev A, Released - Effective on: 19-Nov-2020 - Confidential - Page 28 of 30

Protocol No. T3M3-02-19H04-01  
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Page 29 of 30 
Appendix 1 
 
Alinity s Anti-HCV II Assay 
Supplemental Algorithm 
Donor Specimens 
Alinity s Anti-HCV II Repeatedly Reactive 
and/or Alinity s Anti-HCV Repeatedly Reactive
Alinity s Anti-HCV II Nonreactive and 
Alinity s Anti-HCV Nonreactive
Final Status: Negative
Positive for 
HCV
Negative
Positive for HCV
Negative
*HCV Qualitative RNA
HCV Qualitative RNA
(Individual Discriminatory Test)
Reactive
ROCHE Anti-HCV II
Non-reactive
Gray Zone
 
*The donor center will perform NAT as part of their routine donor testing. If the pool is positive, individual 
discriminatory HCV qualitative RNA will be performed. 
 
 
D000096563 Rev A, Released - Effective on: 19-Nov-2020 - Confidential - Page 29 of 30

Protocol No. T3M3-02-19H04-01  
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Page 30 of 30 
Appendix 1 Continued 
 
Alinity s Anti-HCV II Assay 
Supplemental Algorithm 
Increased Risk Specimens 
 
Alinity s Anti-HCV II Repeatedly Reactive 
and/or Alinity s Anti-HCV Repeatedly Reactive
Alinity s Anti-HCV II Nonreactive and 
Alinity s Anti-HCV Nonreactive
Final Status: Negative
Reactive
ROCHE Anti-HCV II
Non-reactive
Gray Zone
Positive for HCV
Negative
HCV Qualitative RNA
(Individual Discriminatory Test)
 
 
End of Document 
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