Alinity S Product Manual

Anti-HCV II Reagent Kit Created July 2022. Instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from these instructions. lNAME Alinity s Anti-HCV II Reagent Kit Hepatitis C Virus (E coli, Recombinant) NS3 Helicase Antigens and Synthetic Core Peptide lINTENDED USE i The Alinity s Anti-HCV II assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to hepatitis C virus (HCV) in human serum and plasma specimens on the Alinity s System. i 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 assay is also intended for use in testing serum and plasma specimens to screen organ donors when specimens are obtained while the donor's heart is still beating, and in testing serum and EDTA plasma specimens to screen cadaveric (non-heart-beating) donors. It is not intended for use on cord blood specimens. This test is not intended for use as an aid in diagnosis of infection with HCV. lSUMMARY AND EXPLANATION OF THE TEST Hepatitis C virus (HCV) is the causative agent of acute and chronic hepatitis infection. Globally, an estimated 58 million individuals are chronically infected. In 2019, approximately 290 000 people died from HCV-related liver disease, primarily due to cirrhosis and hepatocellular carcinoma (primary liver cancer).1 HCV belongs to the genus Hepacivirus in the family Flaviviridae and is a linear, single-stranded, positive-sense RNA virus. It is divided into at least 6 different genotypes (1-6) and several subtypes based on nucleotide sequence homology.2 Each HCV genotype can be present in any given country, but there are geographical differences in prevalence. Differences between genotypes are associated with responses to treatment.3 HCV is spread through contact with blood from an infected person, such as sharing needles to inject drugs. Less commonly, HCV is transmitted through blood transfusion, sexual or perinatal routes or contact with contaminated personal items. Because of effective blood screening using serological and nucleic acid testing (NAT) methods, the risk of transfusion-transmitted HCV infections has been reduced.4 HCV RNA can be detected within a few days of exposure to HCV, prior to the development of antibodies.2 This time period, referred to as the pre-seroconversion window period, often extends for several weeks after initial infection with HCV. In general, antibodies to HCV are absent in the early weeks of infection and are not detected on average until 8-11 weeks after infection.5 In general 55%-85% of HCV infected individuals develop chronic infection, which is characterized by the continued detection of both HCV RNA and antibodies to HCV, persisting for decades after initial infection.1, 2 About 30% of infected individuals resolve their infection, which is characterized by continued detection of antibodies to HCV, but with HCV RNA no longer being detectable.1, 2 en Anti-HCV II 04W56 H14970R01 B4W5G0 04W5660 Anti-HCV assays are used to identify individuals infected with HCV and to prevent transmission of the virus to recipients of blood or blood products. The Alinity s Anti-HCV II assay is designed to detect antibodies to recombinant antigens representing Core and NS3 regions of the HCV genome. lBIOLOGICAL PRINCIPLES OF THE PROCEDURE This assay is for the qualitative detection of anti-HCV in human serum and plasma using chemiluminescent microparticle mmunoassay (CMIA) technology. Sample, streptavidin-coated microparticles precomplexed with biotinylated HCV constructs, acridinium-labeled HCV conjugate, and assay diluent are combined to create a reaction mixture and ncubated. The anti-HCV present in the sample binds to the HCV-coated microparticles and to the acridinium-labeled HCV conjugate. The mixture is washed. Ancillary wash buffer is added and incubated. Following a wash cycle, Pre-Trigger and Trigger Solutions are added. The resulting chemiluminescent reaction is measured as relative light units (RLU). There is a direct relationship between the amount of anti-HCV in the sample and the RLU detected by the system optics. The presence or absence of anti-HCV in the sample is determined by comparing the chemiluminescent RLU in the reaction to the cutoff RLU determined from an active calibration. For additional information on system and assay technology, refer to the Alinity s System Operations Manual, Section 3. lREAGENTS Kit Contents Alinity s Anti-HCV II Reagent Kit 04W56 NOTE: This product is composed of 4 components, which are packaged as a 2-cartridge reagent set. Both cartridges are required to perform the assay. Volumes (mL) listed in the table below indicate the volume per cartridge set. 04W5660 Tests per cartridge set 500 Number of cartridge sets per kit 5 Tests per kit 2500 27.0 mL 13.8 mL 14.0 mL 26.5 mL Streptavidin-coated microparticles precomplexed with biotinylated HCV antigens (E coli, recombinant) and biotinylated HCV Core synthetic peptide in pyrophosphate-buffered saline with surfactants. Minimum concentration: 0.097% solids. Preservative: sodium azide. Acridinium-labeled HCV antigens (E coli, recombinant) and acridinium-labeled HCV Core synthetic peptide conjugate in pyrophosphate-buffered saline. Minimum concentration: Peptide 50 ng/mL, antigens 200 ng/mL. Preservative: sodium azide. Pyrophosphate-buffered saline with surfactants. Preservative: sodium azide. 1 2 04W5660 Pyrophosphate-buffered saline. Preservative: Storage Temperature Maximum Storage Time Additional Storage Instructions Unopened 2 to 8°C Until expiration date Store in upright position. Opened 2 to 15°C 15 days after opening* Store in upright position. Discard after 15 days. If cartridge does not remain upright during storage off the system, discard the cartridge. Do not reuse original reagent caps or replacement caps due to the risk of contamination and the potential to compromise reagent performance. * Includes time on board the system. Reagents may be stored on or off the system. If removed from the system, store reagents with new replacement caps in an upright position at 2 to 15°C. For reagents stored off the system, it is recommended that they be stored in their original trays or boxes to sodium azide. Warnings and Precautions • • For In Vitro Diagnostic Use • Performance characteristics of this product have not been established for laboratory diagnosis of HCV infection. Safety Precautions CAUTION: This product requires the handling of human specimens. It is recommended that all human-sourced materials and all consumables contaminated with potentially infectious materials be considered potentially infectious and handled in accordance with the OSHA Standard on Bloodborne Pathogens. Biosafety Level 2 or other appropriate regional, national, and institutional biosafety practices should be used for materials that contain, are suspected of containing, or are contaminated with infectious agents.6-9 The following warnings and precautions apply to: / / / Contains sodium azide. EUH032 Contact with acids liberates very toxic gas. P501 Dispose of contents / container in accordance with local regulations. Follow local chemical disposal regulations based on your location along with recommendations and content in the Safety Data Sheet to determine the safe disposal of this product. For the most current hazard information, see the product Safety Data Sheet. Safety Data Sheets are available at www.transfusion.abbott or contact your local representative. For a detailed discussion of safety precautions during system operation, refer to the Alinity s System Operations Manual, Section 8. Reagent Handling • Do not invert reagent cartridges. • Upon receipt, reagent cartridges can be used immediately or stored in an upright position. • If a reagent cartridge is dropped, place in an upright position for 1 hour before use to allow bubbles that may have formed to dissipate. • Reagents are susceptible to the formation of foam and bubbles. Bubbles may interfere with the detection of the reagent level in the cartridge and cause insufficient reagent aspiration that may adversely affect results. For a detailed discussion of reagent handling precautions during system operation, refer to the Alinity s System Operations Manual, Section 7. Reagent Storage • Do not freeze. ensure they remain upright. For information on unloading reagents, refer to the Alinity s System Operations Manual, Section 5. Indications of Reagent Deterioration Deterioration of the reagents may be indicated when a calibration error occurs or a control value is out of the specified range. Associated test results are invalid, and samples must be retested. Assay recalibration may be necessary. For troubleshooting information, refer to the Alinity s System Operations Manual, Section 10. lINSTRUMENT PROCEDURE The Alinity s Anti-HCV II Assay File must be installed on the Alinity s System prior to performing the assay. For detailed information on assay file installation and viewing and editing assay parameters, refer to the Alinity s System Operations Manual, Section 2. For information on printing assay parameters, refer to the Alinity s System Operations Manual, Section 5. For a detailed description of system procedures, refer to the Alinity s System Operations Manual. 3 lSPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS Specimen Types The specimen types listed below were verified for use with this assay. Other specimen types and anticoagulants have not been verified with this assay. Specimen Type Anticoagulant Serum Not Applicable (including serum separator tubes) Plasma Dipotassium EDTA (including plasma preparation tubes) Tripotassium EDTA Lithium heparin (including plasma separator tubes) Sodium citrate Sodium heparin ACD-A ACD-B CP2D CPD CPDA-1 • Liquid anticoagulants may have a dilution effect resulting in lower S/CO values for individual specimens. • Performance has not been established for the use of umbilical cord blood or bodily fluids such as urine, saliva, semen, amniotic fluid, cerebrospinal fluid, or pleural fluid. • Performance has been established for the use of cadaveric serum and EDTA plasma specimens (including specimens collected postmortem, non-heart-beating) that have been collected up to 24 hours after death.10 • Testing of cadaveric serum and EDTA plasma specimens from patients with plasma dilution due to transfusions of 2000 mL of blood or colloids within 48 hours, or 2000 mL of crystalloids within 1 hour (or any combination thereof) prior to collection of the specimens has not been verified. • For cadaveric donors, serum and EDTA plasma may be used; follow general standards and/or regulations for collection, storage and handling. • The system does not provide the capability to verify specimen types. It is the responsibility of the operator to verify that the correct specimen types are used with the assay. Specimen Conditions • Do not use: – heat-inactivated specimens – pooled specimens – grossly hemolyzed specimens – specimens with obvious microbial contamination – specimens with fungal growth • For accurate results, serum and plasma specimens should be free of fibrin, red blood cells, and other particulate matter. • To prevent cross contamination, use of disposable pipettes or pipette tips is recommended. Preparation for Analysis Failure to follow the specified centrifugation procedure may give erroneous or inconsistent test results. • Clear, nonhemolyzed specimens should be used when possible. Specimens containing visible particulate matter may give erroneous or inconsistent test results. • Specimens should be free of bubbles. Remove bubbles with an applicator stick before analysis. Use a new applicator stick for each specimen to prevent cross contamination. • Prior to centrifugation, previously frozen specimens (including previously frozen plasmapheresis specimens) must be mixed gently and thoroughly after thawing. • Specimens collected by plasmapheresis, which have not been frozen, do not require centrifugation. All other specimens (including previously frozen plasmapheresis specimens) must be centrifuged between 30 000 - 75 000 g-minutes. • All specimens must be tested or retested within 48 hours of initial centrifugation. After 48 hours, these specimens need to be recentrifuged between 30 000 - 75 000 g-minutes. The acceptable time and force ranges that meet this criterion are listed in the table below. Centrifugation Time (Minutes) RCF (x g) g-Minutes 10 3000 30 000 15 2000 - 3000 30 000 - 45 000 20 1500 - 3000 30 000 - 60 000 25 1300 - 3000 32 500 - 75 000 Convert rpm to RCF as follows: RCF = 1.12 × rmax (rpm/1000)2 Convert RCF to rpm as follows: RCF - The relative centrifugal force generated during centrifugation. rpm - The revolutions per minute of the rotor on which the specimens are being spun (usually the digital readout on the centrifuge will indicate the rpm). Centrifugation The time should be measured from the time the Time - rotor reaches the required RCF or rpm to the time it begins decelerating. rmax - Radius of the rotor in millimeters. The radius measured is dependent on whether the rotor is a fixed angle rotor or a swinging bucket rotor. This value is typically provided with the rotor by the manufacturer. For the fixed angle rotor, rmax is the measure of the distance from the rotor axis (center) to the bottom of the specimen tube in the rotor or rotor adapter. For the swinging bucket rotor, rmax is the measure of the distance from the rotor axis (center) to the bottom of the specimen tube in the rotor adapter or bucket at full extension. NOTE: If custom tube adapters (i.e., adapters not defined by the centrifuge manufacturer) are used, then the radius (rmax) should be manually measured in millimeters and the RCF calculated. g-minutes - The unit of measure for the product of RCF (× g) and centrifugation time (minutes). Specimen Storage Maximum Specimen Type Temperature Storage Time Special Instructions Living Donor Room 7 days Specimens may be Serum/ temperature stored on or off the Plasma (15 to 30°C) clot, red blood cells, or separator gel. 2 to 8°C 14 days Specimens may be stored on or off the clot, red blood cells, or separator gel. -20°C or 9 months Remove serum or colder plasma from the clot, red blood cells, or separator gel. • Living donor specimens stored at -20°C or colder for greater than 9 months may be used for informational purposes (e.g., lookback testing, discordant sample testing, clinical and validation testing). 4 • Storage at a combination of 15 to 30°C and 2 to 8°C may not exceed 14 days (inclusive of shipping time) and cannot exceed the maximum durations listed in the table above. • Performance has not been established for living donor specimens that have undergone more than 6 freeze/thaw cycles. Maximum Specimen Type Temperature Storage Time Special Instructions Cadaveric Room 3 days If specimens are not Serum/ temperature processed directly EDTA (15 to 30°C) after initial Plasma centrifugation, it is recommended to remove the supernatant from the clot, red blood cells or separator gel until further processing. 2 to 8°C 14 days If specimens are not processed directly after initial centrifugation, it is recommended to remove the supernatant from the clot, red blood cells or separator gel until further processing. -20°C or 9 months If specimens are not colder processed directly after initial centrifugation, it is recommended to remove the supernatant from the clot, red blood cells or separator gel until further processing. • Cadaveric specimens stored at -20°C or colder for greater than 9 months may be used for informational purposes (e.g., lookback testing, discordant sample testing, clinical and validation testing). • Storage at a combination of 15 to 30°C and 2 to 8°C may not exceed 14 days (inclusive of shipping time) and cannot exceed the maximum durations listed in the table above. • Performance has not been established for cadaveric specimens that have undergone more than 6 freeze/thaw cycles. Specimen Shipping Package and label specimens in compliance with applicable state, federal, and international regulations covering the transport of clinical specimens and infectious substances. lPROCEDURE Materials Provided 04W56 Alinity s Anti-HCV II Reagent Kit Materials Required but not Provided • Alinity s Anti-HCV II Assay File • 04W5603 Alinity s Anti-HCV II Calibrator Kit • 04W5620 Alinity s Anti-HCV II Assay Control Kit • 04W5624 Alinity s Anti-HCV II Release Control Kit • Alinity Trigger Solution • Alinity Pre-Trigger Solution • Alinity s Concentrated Wash Buffer For information on materials required for operation of the system, refer to the Alinity s System Operations Manual, Section 1. For information on materials required for maintenance procedures, refer to the Alinity s System Operations Manual, Section 9. Assay Procedure For a detailed description of how to run an assay, refer to the Alinity s System Operations Manual, Section 5. • Primary tubes may be on board the system for up to 10 hours. • If using primary or aliquot tubes, refer to the Alinity s System Operations Manual, Section 4 to ensure sufficient specimen is present. • To minimize the effects of evaporation, verify adequate sample cup volume is present prior to running the test. • Maximum number of replicates sampled from the same sample cup: 10 ≤ 3 hours on the reagent and sample manager: – Sample volume for first test: 350 µL – Sample volume for each additional test from same sample cup: 150 µL 3 hours on the reagent and sample manager: – Replace with a fresh aliquot of sample. • Refer to the Alinity s Anti-HCV II Calibrator Kit, Assay Control Kit, and/or Release Control Kit package inserts for preparation and usage. • For general operating procedures, refer to the Alinity s System Operations Manual, Section 5. • For optimal performance, it is important to perform routine maintenance as described in the Alinity s System Operations Manual, Section 9. Perform maintenance more frequently when required by laboratory procedures. Calibration For instructions on performing a calibration, refer to the Alinity s System Operations Manual, Section 5. Three replicates of Alinity s Anti-HCV II Calibrator 1 are automatically tested by the system. The calibrator must be priority loaded. Each assay control must be tested to evaluate the assay calibration. Once a calibration is accepted and stored, it may be used for 14 days. During this time, all subsequent samples may be tested without further calibration unless: • A reagent kit with a new lot number is used. • Daily quality control results are outside of quality control limits used to monitor and control system performance. This assay may require recalibration after maintenance to critical parts or subsystems or after service procedures have been performed. Quality Control Procedures Assay Controls The Alinity s Anti-HCV II Assay Controls must be tested once every 24 hours when the system is being used. Assay control values must be within the ranges specified in the Alinity s Anti-HCV II Assay Control Kit package insert. When the assay control values are within range, sample results are generated, and a valid release control result is required to release test results. If an assay control value is not within range, sample results are not generated for in-process or scheduled samples. For troubleshooting information, refer to the Alinity s System Operations Manual, Section 10. Release Controls The Alinity s Anti-HCV II Release Control must be tested in order to release test results. The release control is tested at user-defined intervals. For configuring the release control, refer to the Alinity s System Operations Manual, Section 2. For manually ordering the release control, refer to the Alinity s System Operations Manual, Section 5. The release control must meet specifications defined in the Alinity s Anti-HCV II Release Control Kit package insert in order to validate the system functionality and release test results. If the release control does not meet specifications, refer to the Alinity s System Operations Manual, Section 10, for additional information. 5 Other Controls Additional controls may be tested at operator’s discretion in accordance with local, state, and/or federal regulations or accreditation requirements and your laboratory’s quality control policy. For additional information on configuring customer controls, refer to the Alinity s System Operations Manual, Section 2. Invalidate controls: Additional controls may be tested anywhere within a run as an invalidate control. Specifications may be assigned to invalidating controls. If an invalidate control fails to meet assigned specifications, no sample results are calculated or provided by the system. When an invalidate control meets assigned specifications, sample processing continues, and a valid release control result is required to release test results. Non-validating controls: Additional controls may be tested anywhere within a run as a non-validating control. Specifications may be assigned to non-validating controls. A valid release control result is required to release test results. If the user-assigned specifications for the non-validating control(s) are not met and the release control specifications are met, there will be no effect on sample processing. In this case, reactive sample results must not be considered invalid. Quality Control Guidance Refer to “Basic QC Practices” by James O Westgard, Ph.D. for guidance on laboratory quality control practices.11 lRESULTS Calculation The Alinity s System calculates results for the Alinity s Anti-HCV II assay using the ratio of the sample RLU to the cutoff RLU (S/CO) for each specimen and control. Cutoff RLU = Calibrator 1 Mean RLU x 0.219 The cutoff RLU is stored for each reagent lot calibration. S/CO = Sample RLU/Cutoff RLU lLIMITATIONS OF THE PROCEDURE Interpretation of Results The cutoff is 1.00 S/CO. Initial Results Initial Result (S/CO) Interpretation Retest Procedure <1.00 nonreactive="Nonreactive" no="No" retest="Retest" required.="required." specimen="Specimen" considered="considered" negative="negative" for="for" antibodies="antibodies" to="to" hcv.="HCV." ≥="≥" 1.00="1.00" reactive="Reactive" in="in" duplicate.="duplicate." final="Final" interpretation="Interpretation" results="results" (s="(S" co)="CO)" both="Both"><1.00 0="0" 1="1" 2="2" 3="3" 4="4" 5="5" 6="6" 7="7" 8="8" 9="9" 10="10" 12="12" 14="14" 15="15" 20="20" 23="23" 24="24" 29="29" 37="37" 40="40" 55="55" 70="70" 80="80" 131="131" 210="210" 310="310" 314="314" 345="345" 359="359" 360="360" 403="403" 404="404" 414="414" 473="473" 483="483" 506="506" 526="526" 807="807" 902="902" 1000="1000" 1992="1992" 2095="2095" 3000="3000" 3167="3167" 4250="4250" 5277="5277" 7082="7082" 60064="60064" 65205="65205" nonreactive="nonreactive" specimen="specimen" considered="considered" negative="Negative" for="FOR" antibodies="antibodies" to="to" hcv.="HCV." or="or" both="Both" results="Results" repeatedly="repeatedly" reactive="reactive" should="should" be="be" ≥="≥" 1.00="1.00" further="further" tested="Tested" by="by" supplemental="Supplemental" methods.="methods." methods="methods" follow="follow" appropriate="appropriate" fda="FDA" recommendations="Recommendations" and="AND" regulations="regulations" specimens="Specimens" found="found" reactive.="reactive." customers="Customers" outside="outside" the="The" us="US" must="must" their="their" country’s="country’s" government="Government" flags="flags" some="Some" may="may" contain="contain" information="Information" in="In" field.="field." a="A" description="description" of="OF" that="that" appear="appear" this="this" field,="field," refer="Refer" alinity="Alinity" s="S" system="System" operations="Operations" manual,="Manual," section="section" 5.="5." •="•" potential="potential" interference="Interference" has="has" not="Not" been="been" evaluated="evaluated" substances="Substances" other="Other" than="than" those="those" described="described" specific="SPECIFIC" performance="performance" characteristics="CHARACTERISTICS" -="-" package="package" insert.="insert." false="False" can="can" expected="expected" with="with" any="any" test="test" kit.="Kit." falsely="Falsely" elevated="elevated" have="have" observed="observed" due="due" non-specific="non-specific" interactions="interactions" (refer="(refer" insert).="insert)." although="Although" association="association" infectivity="infectivity" presence="presence" hcv="hcv" is="is" strong,="strong," it="it" recognized="recognized" presently="presently" available="available" detection="Detection" are="are" sensitive="sensitive" enough="enough" detect="detect" all="All" potentially="Potentially" infectious="infectious" units="units" blood="Blood" possible="possible" cases="cases" infection.="infection." result="result" does="does" exclude="exclude" collection="COLLECTION" preparation="PREPARATION" analysis="ANALYSIS" insert="insert" limitations.="limitations." lspecific="lSPECIFIC" representative="representative" data="data" provided="provided" section.="section." obtained="obtained" individual="individual" laboratories="Laboratories" vary.="vary." reproducibility="Reproducibility" study="study" was="was" performed="performed" based="Based" guidance="Guidance" from="From" clsi="CLSI" ep05-a3.12="EP05-A3.12" testing="TESTING" conducted="conducted" using="Using" lots="lots" anti-hcv="anti-HCV" ii="II" reagent="reagent" kit,="Kit," calibrator="Calibrator" assay="assay" control="Control" release="Release" panel="panel" members="members" controls="controls" were="were" twice="twice" day="Day" days="days" replicates="Replicates" at="at" sites.="sites." withinmean="WithinMean" within-run="Within-Run" between-run="Between-Run" between-day="between-day" laboratorya="Laboratorya" between-site="Between-Site" between-lot="between-lot" reproducibilityb="Reproducibilityb" sample="Sample" n="Number" co="CO" sd="SD" %cv="%CV" high="high" 0.81="0.81" 0.022="0.022" 2.7="2.7" 0.007="0.007" 0.9="0.9" 0.008="0.008" 1.0="1.0" 0.024="0.024" 3.0="3.0" 0.004="0.004" 0.5="0.5" 0.044="0.044" 5.4="5.4" 0.051="0.051" 6.3="6.3" low="Low" 1.28="1.28" 0.031="0.031" 2.4="2.4" 0.3="0.3" 0.006="0.006" 2.5="2.5" 0.010="0.010" 0.8="0.8" 0.065="0.065" 5.1="5.1" 0.074="0.074" 5.8="5.8" antibody="antibody" 11.12="11.12" 0.282="0.282" 0.000="0.000" 0.0="0.0" 0.534="0.534" 4.8="4.8" 0.610="0.610" 5.5="5.5" positive="positive" 2.82="2.82" 0.053="0.053" 1.9="1.9" 0.072="0.072" 2.6="2.6" 0.093="0.093" 3.3="3.3" 0.05="0.05" 0.003="0.003" na="Not" 0.001="0.001" 0.011="0.011" 0.012="0.012" variation="Variation" expressed="expressed" as="AS" percentage;="percentage;" replicates;="Replicates;" applicable:="Applicable:" %cvs="%CVs" meaningful="meaningful" when="when" approaches="approaches" zero;="zero;" deviation="Deviation" includes="Includes" within-run,="within-run," between-run,="between-run," variability="variability" b="b" between-day,="between-day," between-site,="between-site," between-lot,="between-lot," site-lot="site-lot" interaction="interaction" specificity="specificity" total="Total" fresh="fresh" serum="Serum" plasma="Plasma" volunteer="Volunteer" whole="whole" donors="Donors" collected="collected" distinct="distinct" centers.="centers." plasmapheresis="Plasmapheresis" additional="additional" center.="center." initial="initial" repeat="repeat" rates="rates" 0.11%="0.11%" (6="(6" 5277),="5277)," (8="(8" 7082),="7082)," donor="Donor" 0.19%="0.19%" 3167).="3167)." an="an" qualitative="qualitative" rna="RNA" fda-approved="FDA-approved" immunoassay="immunoassay" anti-hcv.="anti-HCV." specimens,="specimens," positive,="positive," negative.="negative." assumed="assumed" zero="zero" prevalence="prevalence" estimated="estimated" 99.96%="99.96%" (15="(15" 512)="512)" 95%="95%" confidence="confidence" interval="Interval" 99.92%="99.92%" 99.99%.="99.99%." number="number" ir="Initially" rr="Repeatedly" (%="(%" total)="Total)" (%)a="(%)a" category="Category" (95%="(95%" ci)="CI)" rr)="RR)" 99.94="99.94" (0.11)="(0.11)" (50.00)="(50.00)" (5271="(5271" 5274)="5274)" (0.04="(0.04" 0.25)="0.25)" (99.83="(99.83" 99.99)="99.99)" 99.97="99.97" (75.00)="(75.00)" (7074="(7074" 7076)="7076)" (0.05="(0.05" 0.22)="0.22)" (99.90="(99.90" 100.00)="100.00)" 99.96="99.96" (64.29)="(64.29)" (12="(12" 350)="350)" (0.06="(0.06" 0.19)="0.19)" (99.91="(99.91" (0.19)="(0.19)" (83.33)="(83.33)" (3161="(3161" 3162)="3162)" (0.07="(0.07" 0.41)="0.41)" (99.82="(99.82" (0.13)="(0.13)" (70.00)="(70.00)" (0.08="(0.08" 0.20)="0.20)" (99.92="(99.92" ci="Confidence" interval;="Interval;" reactive;="Reactive;" (3="(3" serum,="serum," plasma,="plasma," specimens),="specimens)," specimens);="specimens);" excluded="excluded" calculations.="calculations." donors,="donors," rate="Rate" retest="100%" 0.00%="0.00%" (0="(0" 506)="506)" 0.08%.="0.08%." ×="×" (number="(Number" –="–" sensitivity="Sensitivity" categories="categories" shown="shown" table="table" below="below" clinical="Clinical" individuals="Individuals" increased="Increased" risk="Risk" infection="Infection" 100.00%="100.00%" (403="(403" 403)="403)" 99.09%="99.09%" preselected="Preselected" specimens.="specimens." (%)="(%)" 403c="403c" 100.00="100.00" positivea="Positivea" (100.00)="(100.00)" (99.09="(99.09" infectionb="Infectionb" (19.80)="(19.80)" (87.50)="(87.50)" (70="(70" 70)="70)" (94.87="(94.87" (59.85)="(59.85)" (97.93)="(97.93)" (473="(473" 473)="473)" (99.22="(99.22" assays="assays" fda-licensed="FDA-licensed" nucleic="nucleic" acid="acid" test.="test." following="following" factors="factors" diagnosed="diagnosed" treated="treated" hiv,="HIV," sexual="sexual" contact="Contact" hiv="HIV" infected="infected" individual,="individual," hemodialysis="Hemodialysis" patient,="patient," sex="sex" behaviors,="behaviors," history="history" incarceration,="incarceration," illicit="illicit" drug="Drug" use="Use" (intravenous="(intravenous" intranasal),="intranasal)," intranasal="intranasal" cocaine="cocaine" user,="user," intravenous="intravenous" men="men" who="who" men,="men," multiple="multiple" partners,="partners," occupational="Occupational" exposure,="exposure," tattoo,="tattoo," body="body" piercing="piercing" acupuncture,="acupuncture," persons="persons" known="known" exposure="exposure" hcv,="HCV," transfusion="transfusion" recipient="Recipient" (received="(received" prior="prior" july="July" received="received" donor).="donor)." c="C" three="Three" acute="Acute" medical="Medical" diagnosis="diagnosis" results.="results." genotype="genotype" (genotypes="(genotypes" 1-6)="1-6)" commercial="commercial" vendors="vendors" assay.="assay." compared="compared" commercially="commercially" seroconversion="seroconversion" thirty-eight="Thirty-eight" sets,="sets," consisting="consisting" members,="members," assays.="assays." panels,="panels," same="same" bleed.="bleed." within="within" bleeds="bleeds" earlier="earlier" assay,="assay," while="while" last="last" conditions="conditions" disease="disease" states="states" unrelated="unrelated" evaluated.="evaluated." testing.="testing." reactive)="Reactive)" (0.32)="(0.32)" 1b(0.32)="1b(0.32)" (0.00)="(0.00)" statesa="Statesa" included="included" following:="following:" anti-hiv-1="Anti-HIV-1" hiv-2="HIV-2" (12),="(12)," anti-htlv="Anti-HTLV" i="I" (11),="(11)," hbv="HBV" (25),="(25)," anti-hav="Anti-HAV" (15),="(15)," anti-hdv="Anti-HDV" anti-cmv="Anti-CMV" co-infected="Co-infected" cmv="CMV" ebv="EBV" hsv="HSV" (14),="(14)," anti-t="Anti-T" pallidum="pallidum" non-viral="Non-viral" hepatitis="hepatitis" rheumatoid="Rheumatoid" factor="Factor" anti-ds="Anti-ds" dna="DNA" pregnant="Pregnant" females="Females" multiparous="Multiparous" hyper="Hyper" igg="IgG" igm="IgM" influenza="Influenza" vaccine="Vaccine" patients="Patients" hama="HAMA" e="E" coli="coli" (13),="(13)," heterophilic="Heterophilic" fungal="Fungal" (yeast)="(Yeast)" ana="ANA" autoimmune="Autoimmune" (13).="(13)." interfering="interfering" endogenous="Endogenous" interferents="interferents" above="above" concentrations="concentrations" recommended="recommended" ep37.13="EP37.13" no="no" (spiked)="(spiked)" levels="levels" below.="below." substance="Substance" interferent="Interferent" level="Level" conjugated="Conjugated" bilirubin="Bilirubin" ≤="≤" mg="mg" dl="DL" unconjugated="Unconjugated" hemoglobin="Hemoglobin" triglycerides="Triglycerides" protein="Protein" g="g" addition,="addition," spiked="spiked" biotin="biotin" concentration="concentration" ng="ng" ml.="mL." effect="effect" listed="listed" lperformance="lPERFORMANCE" cadaveric="Cadaveric" twenty-three="Twenty-three" edta="EDTA" living="Living" human="Human" create="create" low-level="low-level" each="each" per="per" over="over" values="values" determined.="determined." totala="Totala" matrix="Matrix" mean="mean" serumb="Serumb" 3.41="3.41" 0.125="0.125" 3.7="3.7" 3.35="3.35" 0.109="0.109" 3.2="3.2" plasmac="Plasmac" 3.93="3.93" 0.113="0.113" 2.9="2.9" 3.90="3.90" 0.096="0.096" contains="Contains" within-specimen,="within-specimen," lot-specimen="lot-specimen" variance="variance" components.="components." up="up" 28.2="28.2" hours="hours" after="after" death.="death." 39.8="39.8" determined="determined" lot="Lot" seruma="Seruma" (93.51="(93.51" plasmab="Plasmab" analytical="Analytical" storage="storage" minimum="minimum" high-level="high-level" spiking,="spiking," prepared="prepared" lots.="lots." spiking="spiking" target="target" analyte="Analyte" value="value" near="near" cutoff="cutoff" 0,="0," then="then" subjected="subjected" either="either" 8°c="8°C" 3.69="3.69" days,="days," room="Room" temperature="Temperature" 30°c)="30°C)" −20°c="−20°C" colder="colder" months,="months," freeze="Freeze" thaw="Thaw" cycles.="cycles." 3.63="3.63" calculating="calculating" differences="Differences" between="between" condition="Condition" related="related" timepoint.="timepoint." percent="percent" 3.66="3.66" there="There" changes="changes" interpretation;="interpretation;" 3.67="3.67" demonstrate="demonstrate" stored="stored" 9.27="9.27" 8.97="8.97" upper="Upper" limit="Limit" lower="Lower" 2-sided="2-sided" timepoint="Timepoint" %="%" 9.26="9.26" seruma,b="Seruma,b" -0.01="-0.01" -10.6%="-10.6%" -9.0%="-9.0%" 9.14="9.14" plasmac,d="Plasmac,d" 0.00="0.00" -8.6%="-8.6%" -9.2%="-9.2%" 9.09="9.09" -20°c="-20°C" months="months" 6.2%="6.2%" 0.02="0.02" 5.4%="5.4%" 4.31="4.31" cycles="cycles" 0.01="0.01" 0.1%="0.1%" 4.18="4.18" 1.1%="1.1%" 4.32="4.32" 4.09="4.09" ranged="ranged" dl.="dL." 4.00="4.00" 25.5="25.5" 4.10="4.10" 10.89="10.89" d="d" 24.5="24.5" 10.43="10.43" analysis,="ANALYSIS," 10.86="10.86" maximum="maximum" times="times" allowed.="allowed." 10.60="10.60" 10.08="10.08" 10.54="10.54" lbibliography="lBIBLIOGRAPHY" 1.="1." world="World" health="Health" organization.="Organization." fact="fact" sheet.="sheet." http:="http:" www.who.="www.who." int="int" news-room="news-room" fact-sheets="fact-sheets" detail="detail" hepatitis-c.="hepatitis-c." updated="Updated" june="June" 24,="24," 2022.="2022." accessed="Accessed" 8,="8," 2.="2." dienstag="Dienstag" jl.="JL." viral="Viral" hepatitis.="Hepatitis." in:="In:" longo="Longo" fauci="Fauci" editors.="editors." harrison="Harrison" gastroenterology="Gastroenterology" hepatology.="Hepatology." mcgraw-hill;="McGraw-Hill;" 2010:349–="2010:349–" 377.="377." 3.="3." gower="Gower" e,="E," estes="Estes" c,="C," blach="Blach" s,="S," et="et" al.="al." global="Global" epidemiology="epidemiology" distribution="distribution" virus="virus" j="J" hepatol.="Hepatol." 2014;61(1="2014;61(1" suppl):s45-57.="Suppl):S45-57." 4.="4." dwyre="Dwyre" dm,="DM," fernando="Fernando" lp,="LP," holland="Holland" pv.="PV." b,="B," transfusion-transmitted="transfusion-transmitted" infections="infections" 21st="21st" century.="century." vox="Vox" sang.="Sang." 2011;100(1):92–98.="2011;100(1):92–98." center="Center" control.="Control." questions="Questions" answers="Answers" professionals.="Professionals." https:="https:" www.cdc.gov="www.cdc.gov" hcvfaq.htm#ref12.="hcvfaq.htm#Ref12." august="August" 7,="7," 2020.="2020." 6.="6." department="Department" labor,="Labor," safety="Safety" administration,="Administration," cfr="CFR" part="part" 1910.1030,="1910.1030," bloodborne="Bloodborne" pathogens.="pathogens." 7.="7." services.="Services." biosafety="Biosafety" microbiological="Microbiological" biomedical="Biomedical" laboratories.="Laboratories." 6th="6th" ed.="ed." washington,="Washington," dc:="DC:" printing="Printing" office;="Office;" 8.="8." laboratory="Laboratory" manual.="Manual." 4th="4th" geneva:="Geneva:" organization;="Organization;" 9.="9." standards="Standards" institute="Institute" (clsi).="(CLSI)." protection="Protection" workers="Workers" occupationally="Occupationally" acquired="Acquired" infections;="Infections;" approved="Approved" guideline—fourth="Guideline—Fourth" edition.="Edition." document="Document" m29-a4.="M29-A4." wayne,="Wayne," pa:="PA:" clsi;="CLSI;" 2014.="2014." 10.="10." u.s.="U.S." services,="Services," food="Food" biologics="Biologics" evaluation="Evaluation" research.="Research." industry="Industry" obtaining="Obtaining" labeling="Labeling" claim="Claim" communicable="Communicable" screening="Screening" tests="Tests" cells,="Cells," tissues,="Tissues," cellular="Cellular" tissue-based="Tissue-Based" products="Products" (hct="(HCT" ps),="Ps)," november="November" 2004.="2004." www.fda.gov="www.fda.gov" cber="CBER" guidelines.htm="guidelines.htm" 11.="11." westgard="Westgard" jo.="JO." basic="Basic" qc="QC" practices.="Practices." 3rd="3rd" madison,="Madison," wi:="WI:" quality="Quality" corporation;="Corporation;" 2010.="2010." 12.="12." precision="Precision" quantitative="Quantitative" measurement="Measurement" procedures:="Procedures:" guideline—third="Guideline—Third" ep05-a3.="EP05-A3." 13.="13." tables="Tables" chemistry.="Chemistry." 1st="1st" supplement="supplement" ep37.="EP37." 2018.="2018." note="Note" formatting:="formatting:" space="space" used="used" thousands="thousands" separator="separator" (example:="(example:" 000="000" specimens).="specimens)." period="period" separate="separate" integer="integer" fractional="fractional" written="written" decimal="decimal" form="form" 3.12%).="3.12%)." lkey="lKey" symbols="Symbols" consult="Consult" instructions="instructions" manufacturer="Manufacturer" sufficient="Sufficient" limitation="limitation" expiration="Expiration" date="date" diluent="Diluent" ancillary="Ancillary" wash="Wash" buffer="Buffer" conjugate="Conjugate" sodium="Sodium" azide.="Azide." acids="acids" liberates="liberates" very="very" toxic="toxic" gas.="gas." distributed="Distributed" usa="USA" needed="needed" united="United" america="America" vitro="Vitro" diagnostic="Diagnostic" device="Device" microparticles="Microparticles" product="Product" germany="Germany" list="List" serial="Serial" brand="brand" marks="marks" trademarks="trademarks" abbott.="Abbott." property="property" respective="respective" owners.="owners." abbott="Abbott" gmbh="GmbH" max-planck-ring="Max-Planck-Ring" wiesbaden="Wiesbaden" [phone]="[phone]" park,="Park," il="IL" customer="Customer" service:="Service:" your="your" local="local" find="find" country-specific="country-specific" www.transfusion.abbott="www.transfusion.abbott" license="License" no.="No." created="Created" ©2022="©2022"></1.00></1.00>