INSTRUCTIONS FOR USE VITROS Chemistry Products PCP Reagent
PCP Phencyclidine 680 1998
Rx ONLY
Intended Use
For in vitro diagnostic use only. VITROS Chemistry Products PCP Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the semi-quantitative or qualitative determination of phencyclidine (PCP) in human urine using a cutoff of 25 ng/mL. Measurements obtained with the VITROS PCP method are used in the diagnosis and treatment of phencyclidine use or overdose. The VITROS Chemistry Products PCP assay is intended for use by professional laboratory personnel. It provides only a preliminary test result. A more specific alternative chemical method must be used to confirm a result obtained with this assay. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when evaluating a preliminary positive result.
Summary and Explanation of the Test Phencyclidine, also known as PCP and “angel dust,” is a synthetic drug that was originally developed for its anesthetic properties but is now a drug of abuse used solely for its potent hallucinogenic effects. Phencyclidine can be ingested, inhaled, or injected intravenously. 1, 2 Phencyclidine is absorbed well and quickly, and concentrates in the brain and fatty tissues. Phencyclidine is metabolized by the liver through oxidative hydroxylation. Approximately 30 to 50% of a dose is excreted over a 72-hour period. Of the amount excreted, 20% is unchanged drug and 80% are polar metabolites (mainly 4phenyl-4-(1-piperidinyl) cyclohexanol). 2, 3 The VITROS Chemistry Products PCP assay detects phencyclidine in human urine. Measurements of phencyclidine on the VITROS 5600 Integrated System and VITROS 5,1 FS/4600 Chemistry Systems are used in the diagnosis and treatment of phencyclidine use and overdose.
Principles of the Procedure The VITROS PCP assay is a homogeneous enzyme immunoassay that is performed using the VITROS Chemistry Products PCP Reagent with the VITROS Chemistry Products Calibrator Kit 26, VITROS Chemistry Products FS Calibrator 1, and VITROS Chemistry Products FS Diluent Pack 4 (DAT Diluent/DAT Diluent 2) on the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600 Integrated System. The VITROS PCP Reagent is a dual-chambered package containing ready-to-use liquid reagents that are used to detect phencyclidine in urine. Sample, calibrators, and controls are automatically treated with surfactant (DAT Diluent 2) prior to addition of reagents. Treated sample is added to Reagent 1 containing antibodies reactive to phencyclidine, glucose-6phosphate and nicotinamide adenine dinucleotide (NAD+), followed by Reagent 2 containing phencyclidine labeled with the enzyme glucose-6-phosphate dehydrogenase (G6P-DH). The assay is based on competition between phencyclidine in the treated urine sample and phencyclidine labeled with the enzyme glucose-6-phosphate dehydrogenase (G6P-DH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, therefore the concentration of phencyclidine in the urine sample is directly proportional to measured enzyme activity. Active enzyme converts oxidized nicotinamide adenine dinucleotide (NAD+) to NADH, resulting in an absorbance increase that is measured spectrophotometrically at 340 nm.
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INSTRUCTIONS FOR USE
Phencyclidine
Warnings and Precautions
Test Type and Conditions Test Type Two-point Rate
VITROS System 5600, 4600, 5,1 FS
Approximate Incubation Time Incubation 1: 5 minutes Incubation 2: 4 minutes
Temperature
Wavelength
Reaction Sample Volume
37 °C (98.6 °F)
340 nm
5.0 µL
NOTE: See Specimen Testing for minimum sample volume requirements. Not all products and systems are available in all countries.
Reaction Scheme Step 1: Sample Treatment DAT Diluent 2
Sample (PCP)
Treated Sample (PCP)
Step 2: Addition of Reagents Ab + PCP + PCP*
PCP*-Ab + PCP* + PCP-Ab
Glucose-6phosphate + NAD+
PCP*
6-Phosphogluconolactone + NADH + H+
Ab = antibodies reactive to phencyclidine PCP*= phencyclidine–Glucose-6-P-dehydrogenase conjugates
Warnings and Precautions
For in vitro diagnostic use only. WARNING:
This reagent contains bovine blood components. This product should be handled using the same precautions as with any other blood or blood-derived product.
WARNING:
Take care when handling materials and samples of human origin. Since no test method can offer complete assurance that infectious agents are absent, consider all clinical specimens, controls, and calibrators potentially infectious. Handle specimens, solid and liquid waste, and test components in accordance with local regulations and CLSI document M29 4 or other published biohazard safety guidelines.
WARNING:
Contains Mixture, 3(2H)-isothiazolone, 5-chloro-2-methyl-with 2-methyl-3(2H)isothiazolone (CAS 55965-84-9) 5 VITROS PCP Reagents 1 and 2 contain Mixture, 3(2H)-isothiazolone, 5-chloro-2methyl-with 2-methyl-3(2H)-isothiazolone. H317: May cause an allergic skin reaction. P280: Wear protective gloves/protective clothing/eye protection/face protection. P302 + P352: IF ON SKIN: Wash with plenty of soap and water. P333 + P313: If skin irritation or rash occurs: Get medical advice/attention. P363: Wash contaminated clothing before reuse. Refer to www.orthoclinical.com for the Safety Data Sheets and for OCD contact information. WARNING
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PCP
Reagents
Phencyclidine
For specific warnings and precautions for calibrators, quality control materials, and other components, refer to the Instructions for Use for the appropriate VITROS product, or to other manufacturer’s product literature.
Reagents Reactive Ingredients Reagent 1 (R1): Sheep polyclonal antibodies reactive to phencyclidine 0.2 μg/mL; Glucose-6-phosphate (Na-G6P) 5.5 mM; Nicotinamide adenine dinucleotide (NAD) 3.5 mM. Reagent 2 (R2): Phencyclidine labeled with glucose-6-phosphate dehydrogenase (G6P-DH, EC 1.1.1.49, from Leuconostoc mesenteroides) 0.47 U/mL.
Other Ingredients Reagent 1 (R1): Organic salt, proteins, inorganic polymer, protease inhibitor, surfactant, preservative. Reagent 2 (R2): Buffers, inorganic salt, organic salt, proteins, protease inhibitor, biological material, surfactant, preservatives.
Reagent Handling Caution: • • • •
Do not use reagent packs with damaged or incompletely sealed packaging.
Inspect the packaging for signs of damage. Be careful when opening the outer packaging with a sharp instrument so as to avoid damage to the individual product packaging. Reagents are supplied ready for use. Avoid agitation, which may cause foaming or the formation of bubbles.
Reagent Preparation 1. Remove from refrigerated storage. 2. Immediately load into Supply 3. IMPORTANT:
Do not loosen or remove caps prior to loading.
Reagent Storage and Stability VITROS Chemistry Products PCP Reagent is stable until the expiration date on the carton when stored and handled as specified. Do not use beyond the expiration date. Reagent Unopened Opened
IMPORTANT:
Storage Condition Refrigerated 2–8 °C (36–46 °F) 5,1 FS: On-analyzer System turned on 4600/5600: OnSystem turned on analyzer On-analyzer System turned off
Stability Until expiration date ≤ 14 days ≤ 28 days ≤ 30 minutes
In order to ensure the established stability for open (in use) packs, VITROS Chemistry Products PCP Reagent packs must not be transferred from the VITROS 5,1 FS Chemistry System to either the VITROS 4600 Chemistry System or the VITROS 5600 Integrated System.
Verify performance with quality control materials after reloading reagents that have been removed from Supply 3 and stored refrigerated for later use.
Specimen Collection, Preparation and Storage Specimens Recommended Urine.
Specimens Not Recommended Urine samples containing preservatives or additives. 6
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Phencyclidine
Testing Procedure
Urine Specimen Collection and Preparation Urine samples should be collected in the manner routinely used for drug screening analysis. 6 Patient Preparation No special patient preparation is necessary. Special Precautions Adulteration of the urine specimen may cause erroneous results. Obtain another specimen if adulteration is suspected. 6
Specimen Handling and Storage • • • • •
Human urine specimens should be handled and treated as if potentially infectious. Handle and store specimens in closed containers to avoid contamination and evaporation. Mix samples by gentle inversion and bring to room temperature, 18–28 °C (64–82 °F), prior to analysis. Centrifuge specimens with high turbidity before analysis. 6, 7 Thaw frozen samples, mix by gentle inversion, and centrifuge before analysis.
Specimen Storage and Stability Storage Room temperature Refrigerated Frozen
Temperature 18–28 °C (64–82 °F) 2–8 °C (36–46 °F) ≤-20 °C (≤-4 °F)
Stability ≤ 5 days 6 ≤ 5 days 6 ≤ 12 months 8
Testing Procedure Materials Provided VITROS Chemistry Products PCP Reagent
Materials Required but Not Provided • • • •
VITROS Chemistry Products Calibrator Kit 26 VITROS Chemistry Products FS Calibrator 1 VITROS Chemistry Products FS Diluent Pack 4 (DAT Diluent/DAT Diluent 2) Quality control materials, such as VITROS Chemistry Products DAT Performance Verifiers I, II, and V.
Operating Instructions • •
Check reagent inventories at least daily to ensure that quantities are sufficient for the planned workload. For additional information, refer to the operating instructions for your system.
IMPORTANT:
Bring all fluids and samples to room temperature, 18–28 °C (64–82 °F), prior to analysis.
Specimen Testing A minimum of 180 µL of sample, in addition to the minimum amount necessary for the sample container in use on the system, is required. Note:
Studies demonstrate that some drugs, such as Δ9-tetrahydrocannabinol, can interact with some types of sample containers, leading to lower than expected recovery. 9, 10 Ensure that the sample containers in use are appropriate for the assays being run. Refer to the individual assay Instructions for Use for sample handling and testing requirements.
Sample Dilution IMPORTANT:
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Due to the sensitivity of the VITROS PCP Assay to drugs or metabolites other than phencyclidine that may be present in urine samples, specimen dilutions should only be used as an estimation for GC/MS confirmatory testing and are not intended for reporting patient values.
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PCP
Calibration
Phencyclidine
Calibration Required Calibrators • •
VITROS Chemistry Products Calibrator Kit 26 VITROS Chemistry Products FS Calibrator 1
Calibrator Preparation, Handling, and Storage Refer to the Instructions for Use for VITROS Chemistry Products Calibrator Kit 26 and VITROS Chemistry Products FS Calibrator 1.
Calibration Procedure Refer to the operating instructions for your system. IMPORTANT:
When loading the calibration tray, place 300 µL VITROS Chemistry Products FS Calibrator 1 in a cup and place in position 1 of the sample tray. Place 300 µL VITROS Chemistry Products Calibrator Kit 26 into each of 4 cups and place in positions 2–5 of the sample tray. The analyzer will dilute each cup accordingly to establish the calibration curve.
When to Calibrate Calibrate: • When the reagent lot number changes. • When critical system parts are replaced due to service or maintenance. • When government regulations require. For example, in the USA, CLIA regulations require calibration or calibration verification at least once every six months. The VITROS PCP assay may also need to be calibrated: • If quality control results are consistently outside acceptable range. • After certain service procedures have been performed. For additional information, refer to the operating instructions for your system.
Calculations Absorbance is measured at 340 nm after a fixed incubation. Once a calibration has been performed for each reagent lot, phencyclidine concentration in the unknown samples can be determined using the stored calibration curve and the calculated response obtained in the assay of each sample.
Validity of a Calibration Calibration parameters are automatically assessed by the system against a set of quality parameters detailed in the Review Assay Data screen (found via Options → Review/Edit Calibrations → Review Assay Data). Failure to meet any of the predefined quality parameters results in a failed calibration. The calibration report should be used in conjunction with quality control results to determine the validity of a calibration.
Measuring (Reportable) Range See Interpretation of Results and Expected Results.
Traceability of Calibration The values assigned to the VITROS Chemistry Products Calibrator Kit 26 for phencyclidine are traceable to Cerilliant phencyclidine standard catalogue P-047 through gravimetric addition, verified by GC/MS.
Quality Control Quality Control Material Selection IMPORTANT:
VITROS Chemistry Products DAT Performance Verifiers I, II, and V are recommended for use with the VITROS 5,1 FS/4600 Chemistry and VITROS Integrated Systems. Evaluate the performance of other commercial control fluids for compatibility with this test before using for quality control.
Control materials other than VITROS Chemistry Products DAT Performance Verifiers I, II, and V may show a difference when compared with other phencyclidine methods if they: • Depart from a true human matrix. • Contain high concentrations of preservatives, stabilizers, or other nonphysiological additives.
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Phencyclidine •
Results
Contain drugs or drug metabolites other than phencyclidine.
Quality Control Procedure Recommendations • • •
• • •
Choose control levels that are appropriate for the selected cutoff value. Analyze quality control materials in the same manner as patient samples, before or during patient sample processing, or as defined by local government regulations. To verify system performance, analyze control materials: – After calibration. – According to local regulations or at least once each day that the test is being performed. – After specified service procedures are performed. Refer to the operating instructions for your system. If control results fall outside your acceptable range, investigate the cause before deciding whether to report patient results. For general quality control recommendations, refer to CLSI Statistical Quality Control for Quantitative Measurements: Principles and Definitions; Approved Guideline–Third Edition 11 or other published guidelines. For additional information, refer to the operating instructions for your system.
Quality Control Material Preparation, Handling, and Storage Refer to the Instructions for Use for VITROS Chemistry Products DAT Performance Verifiers I, II, and V or to other manufacturer's product literature.
Results Reporting Units and Unit Conversion The VITROS Integrated and VITROS 5,1 FS/4600 Chemistry Systems may be programmed to report PCP results in conventional or SI units. Conventional Units ng/mL
SI Units µg/L (ng/mL x 1.0)
Limitations of the Procedure Known Interferences Interferent Concentration Cutoff Value (ng/mL or µg/L)
25
Interferent*
Conventional (mg/dL)
brompheniramine desipramine
SI (µmol/L)
Bias (ng/mL or µg/L)**
1
31.3
+10.7
5
187.7
+8.2
dextromethorphan
1
36.8
+24.1
dicyclomine
2.5
80.8
+7.9
doxylamine
10
369.8
+5.6
diethylproprione
10
487.1
+5.1
imipramine
1
31.6
+8.7
l‑hyoscyamine
5
147.8
+5.3
meperidine
1.25
50.6
+23.3 +9.9
ofloxacin
10
276.7
phenyltoloxamine
2.5
55.9
+5.9
promethazine
2.5
87.9
+17.4
sertraline
10
327
+6.3
trihexylphenidyl
2.5
82.9
+30.9
tripelannamine
2.5
97.9
+10.4
triprolidine
0.5
18.0
+15.4
*The
degree of interference at concentrations other than those listed might not be predictable from these results. Other interfering substances may be encountered in the patient population.
**The
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bias is an estimate of the maximum difference observed.
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PCP
Interpretation of Results and Expected Results
Phencyclidine
Other Limitations Adulteration of the urine specimen may cause erroneous results. 6
Interpretation of Results and Expected Results Understanding the Test Results A positive test result does not always mean a person consumed phencyclidine, and a negative test result does not rule out consumption of phencyclidine. The VITROS PCP assay provides only a preliminary test result. A more specific analytical method must be used to confirm a result obtained with this assay. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when evaluating a preliminary positive result. 12
Cutoff Value Configuration • • • •
The cutoff value may be configured on the analyzer screen via Options → Configure Assays → Review/Edit Configuration. The default cutoff value is 25 ng/mL. Only one cutoff value is supported at a time. The phencyclidine cutoff value of 25 ng/mL is supported by Ortho-Clinical Diagnostics, Inc. Other cutoff values have not been validated. Enter the selected cutoff value into the range field. Results are reported as either positive or negative versus the chosen cutoff value.
Qualitative Result Mode The system performs all calculations internally to produce the final qualitative result, reported as positive or negative. The qualitative result is based on a comparison between the sample concentration predicted from the calibration curve and the selected cutoff value. A sample concentration greater than or equal to the cutoff value is reported as positive, and a sample concentration less than the cutoff value is reported as negative. If a semi-quantitative value is not desired, then uncheck the appropriate check boxes as described below.
Semi-quantitative Result Mode The system will also provide semi-quantitative values. The semi-quantitation of positive results enables laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC/MS (see Sample Dilution). It also permits the laboratory to establish quality control procedures and assess control performance. The operator can choose to have semi-quantitative values printed on the Laboratory and Patient Reports, and/or uploaded to the Laboratory Information System (LIS). The system performs all calculations internally to produce the final semiquantitative value, reported in ng/mL or μg/L. • The semi-quantitative value reporting mode may be configured on the analyzer screen via Options → Configure Assays → Review/Edit Configuration. • Place a check in the appropriate Check Box to display the semi-quantitative value on the designated report, or to upload the value to the Laboratory Information System (by default, a check appears in the box next to Lab/Results and LIS). If the semi-quantitative value is not desired, then uncheck the appropriate check boxes. • Semi-quantitative values are reported on the selected reports. In addition, results are reported as either positive or negative versus the chosen cutoff value. Note:
If a urine sample generates a response that is above or below the limits of the assay, one of two condition codes – "U91-181 Average response too high" or "U91-186 Average response too low" – will be generated. In this case, a semiquantitative value cannot be predicted, but a positive or negative qualitative result can be generated. The analyzer software determines that the high or low response is within a range of the calibration response curve consistent with a positive or negative result relative to the cutoff value. Thus, a "too high" response would indicate a positive result, and a "too low" response would indicate a negative result.
Measuring (Reportable) Range
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Conventional Units ng/mL
SI Units μg/L
6.0–72.0
6.0–72.0
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PCP
Phencyclidine
Performance Characteristics
Performance Characteristics Method Comparison A total of 138 human urine samples were assayed using the VITROS Chemistry Products PCP Reagent, a commercially available immunoassay method, and a GC/MS reference method for phencyclidine. Percent agreement was evaluated at an assay cutoff value of 25 ng/mL. To challenge performance at the 25 ng/mL cutoff value, 22 of the 138 samples tested had concentrations within ±50% of the cutoff value, 11 samples below the cutoff value and 11 samples above the cutoff value.
Commercial Method Comparison Commercial Method**
Cutoff Value (ng/mL)
25
Low Negative
% Agreement High Positive
(37.5 ng/mL
0
0
10
62
11
1*
0
VITROS Positive VITROS Negative *
Near Cutoff Near Cutoff Negative Positive
54
% Agreement Negative
% Agreement Positive
% Agreement Overall
100.0
98.6
99.3
See Summary of Discordant Results below.
**
Syva® Emit® II Plus Phencyclidine Assay
Summary of Discordant Results: Commercial Method Cutoff Value (ng/mL)
VITROS PCP Assay (ng/mL)
Commercial Method (ng/mL)
25
24.5
25.2
A total of 138 human urine samples were assayed using the VITROS Chemistry Products PCP Reagent and a GC/MS reference method for phencyclidine. Percent agreement was evaluated at an assay cutoff value of 25 ng/mL. To challenge performance at the 25 ng/mL cutoff value, 27 of the 138 samples tested had concentrations within ± 50% of the cutoff value, 13 samples below the cutoff value and 14 samples above the cutoff value.
GC/MS Reference Method Comparison Cutoff Value (ng/mL)
25
VITROS Positive VITROS Negative *
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GC/MS Reference Method Low Negative
Near Cutoff Near Cutoff Negative Positive
% Agreement High Positive
(37.5 ng/mL
0
5*
12
55
8
2*
0
56
% Agreement Negative
% Agreement Positive
% Agreement Overall
92.8
97.1
94.9
Summary of Discordant Results below
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INSTRUCTIONS FOR USE
Performance Characteristics
Phencyclidine
Summary of Discordant Results: GC/MS Cutoff Value (ng/mL)
25
VITROS PCP Assay (ng/mL)
GC/MS (ng/mL)
24.5
25
24.5
36.6
29
23
29.4
23
29.9
23
36.3
22
40.5
24
Major Drug Present by GC/MS
Phencyclidine
Method Comparison between the VITROS 5,1 FS Chemistry System† and the VITROS 5600 Integrated System
Two hundred forty human urine samples were assayed using the VITROS Chemistry Products PCP Reagent on the VITROS 5600 Integrated System and the VITROS 5,1 FS Chemistry System. Percent agreement was evaluated at an assay cutoff value of 25 ng/mL. Cutoff Value (ng/mL)
% Agreement Negative
% Agreement Positive
% Agreement Overall
25
100.0
98.2
99.2
†
Analytical processing hardware and software algorithms on the VITROS 4600 Chemistry System are designed to the same specifications as those applied to the VITROS 5,1 FS Chemistry System. Assay performance on the VITROS 4600 System has been demonstrated to be comparable to that on the VITROS 5,1 FS System. All performance characteristics for VITROS 5,1 FS System are therefore applicable to the VITROS 4600 System.
Analytical Recovery of Semi-Quantitative Results Nine admixtures were prepared from two human urine pools. Phencyclidine values for the admixtures were calculated based on GC/MS results of the high and low pools. Percent recovery was calculated using the concentration obtained by the VITROS Chemistry Products PCP Assay versus the calculated phencyclidine value. Calculated Phencyclidine (ng/mL)
VITROS PCP Assay (ng/mL)
% Recovery
8
8.4
105.1
12
12.0
100.0
16
16.2
101.6
24
24.1
100.5
32
32.4
101.2
40
39.7
99.3
48
48.6
101.3
56
58.1
103.7
64
66.5
103.9
Precision Imprecision was evaluated with human urine based quality control materials on the VITROS 5,1 FS Chemistry System and the VITROS 5600 Integrated System following NCCLS Protocol EP5 13 and NCCLS protocol EP12. 14 These results are guidelines. Variables such as instrument maintenance, environment, reagent storage/handling, control material reconstitution, and sample handling can affect the reproducibility of test results.
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Phencyclidine
Performance Characteristics
Imprecision: Semi-Quantitative Conventional Units (ng/mL) and SI Units (μg/L)
5,1 FS†
5600 *
Mean Conc.
Within Day SD*
Within Lab SD**
Within Lab CV%**
No. Observ.
No. Days
18.3
0.79
1.55
8.5
86
22
30.8
1.02
1.66
5.4
86
22
63.3
1.44
2.89
4.6
86
22
18.8
0.67
0.75
4.0
88
22
31.3
0.62
0.80
2.6
88
22
59.6
1.06
1.41
2.4
88
22
Within Day imprecision was determined using one to two runs per day with two replications per run.
**
Within Lab imprecision was determined using a single lot of reagents with one analyzer and at least four calibrations.
†
Analytical processing hardware and software algorithms on the VITROS 4600 Chemistry System are designed to the same specifications as those applied to the VITROS 5,1 FS Chemistry System. Assay performance on the VITROS 4600 System has been demonstrated to be comparable to that on the VITROS 5,1 FS System. All performance characteristics for VITROS 5,1 FS System are therefore applicable to the VITROS 4600 System.
Qualitative imprecision was assessed using test fluids targeted at ± 25% of each cutoff. The imprecision was determined as the confidence level of obtaining a correct result with known positive or negative fluids.
Imprecision : Qualitative* Cutoff Level (ng/mL & μg/L)
Test Fluid at ± 25% Cutoff
Number of Observations
Number of Correct Interpretations
Confidence Level
-25%
86
86
>95% negative reading
+25%
86
86
>95% positive reading
-25%
88
88
>95% negative reading
+25%
88
88
>95% positive reading
25
5,1 FS† 5600
25
*
Determined using one to two runs per day with two replicates per run for 22 days, using a single lot of reagents with one analyzer and at least four calibrations.
† Analytical processing hardware and software algorithms on the VITROS 4600 Chemistry System are designed to the same specifications as those applied to the VITROS 5,1 FS Chemistry System. Assay performance on the VITROS 4600 System has been demonstrated to be comparable to that on the VITROS 5,1 FS System. All performance characteristics for VITROS 5,1 FS System are therefore applicable to the VITROS 4600 System.
Specificity Substances that Do Not Interfere The substances listed in the table, at the concentrations shown, were tested according to NCCLS Protocol EP7 15 and found not to interfere, bias
