(421 days)
Not Found
No
The device description and performance studies focus on a standard turbidimetric immunoassay methodology, with no mention of AI or ML techniques.
No
This device is for in vitro diagnostic testing to measure total IgE levels, used in the diagnosis of IgE-mediated allergies. It does not provide any therapeutic benefit or treatment.
Yes
The device determines total IgE in human serum or plasma, which is stated to be useful in the clinical diagnosis of IgE-mediated allergies. The phrase "clinical diagnosis" explicitly indicates a diagnostic purpose.
No
The device description clearly states it is a "suspension of polystyrene latex particles" and a "reagent," indicating it is a physical chemical product used in a laboratory setting, not a software-only device.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "Automated latex enhanced immunoassay for the quantitative in vitro determination of total immunoglobulin E (1gE) in human serum or plasma...". The phrase "in vitro determination" is a key indicator of an IVD.
- Sample Type: The device analyzes human serum or plasma, which are biological samples taken from the body for diagnostic purposes.
- Purpose: The measurement of total IgE is stated to be "useful in the clinical diagnosis of IgE-mediated allergies," indicating a diagnostic purpose.
- Methodology: The description of the methodology (Turbidimetric/Immunoturbidimetric) involves laboratory techniques performed on the sample outside of the body.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Automated latex enhanced immunoassay for the quantitative in vitro determination of total immunoglobulin E (1gE) in human serum or plasma (EDTA, heparin, citrate) using the ARCHITECT c Systems. The measurement of total IgE is useful in the clinical diagnosis of IgE-mediated allergies, if used in conjunction with other clinical studies.
Product codes (comma separated list FDA assigned to the subject device)
DGC
Device Description
The Quantia IgE reagent is a suspension of polystyrene latex particles of uniform size coated with mouse anti-human IgE. When a sample containing IgE is mixed with the latex reagent and the reaction buffer included in the kit, agglutination occurs. The degree of agglutination is directly proportional to the concentration of IgE in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates. Methodology: Turbidimetric/Immunoturbidimetric.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Linearity:
A study was performed based on guidance from CLSI EP06 2nd ed. Two high-analyte samples (human serum IgE at approximately 1040.1 and 1018.1 IU/mL) and 2 zero-analyte samples (IgE-depleted serum) were combined at different proportions to make 2 linearity panels that each consisted of samples with concentrations evenly distributed across the intended analytical measuring interval.
The assay demonstrated acceptable linearity across the analytical measuring interval of 20.0 to 1000.0 IU/mL.
Lower Limits of Measurement (LoB, LoD, LoQ):
A study was performed based on guidance from CLSI EP17-A2. The limit of blank (LoB), limit of detection (LoD), and limit of quantitation (LoQ) values are summarized below. These representative data support the lower limit of the analytical measuring interval.
LoB: 6.2 IU/mL
LoD: 11.6 IU/mL
LoQ: 20.0 IU/mL
Interfering Substances:
Potentially Interfering Endogenous Substances: A study was performed based on guidance from CLSI EP07-A2. and CLSI EP37, 1st ed. Each substance was tested at 1 analyte level (approximately 90.0 IU/mL).
No Significant Interference (Interference within ± 5%) was observed for Bilirubin (conjugated) at 40 mg/dL, Bilirubin (unconjugated) at 40 mg/dL, Hemoglobin at 1000 mg/dL, Lipemia (chyle) at 2.4 AU/cm at 660 nm, Lipemia (triglyceride) at 1500 mg/dL.
Potentially Interfering Other Substances: A study was performed based on guidance from CLSI EP07-A2, CLSI EP07, 3rd ed. and CLSI EP37, 1st ed.
No Significant Interference (Interference within ± 10%) was observed for HAMA at 0.100 mg/dL (IgE Target 99.0 IU/mL, % Difference 0.4) and RF at 138 IU/mL (IgE Target 90.0 IU/mL, % Difference 1.3).
Potentially Interfering Drugs: A study was performed based on guidance from CLSI EP07-A2 and CLSI EP37, 1st ed. Each substance was tested at 1 analyte level (approximately 99.0 IU/mL).
No Significant Interference (Interference within ± 10%) was observed for various drugs including Acetaminophen, Acetylcysteine, Acetylsalicylic acid, Ampicillin, Cefoxitin, Cetirizine, Cyclosporine, Diphenhydramine, Doxycycline, Fexofenadine, Heparin, Ibuprofen, Levodopa, Methyldopa, Metronidazole, Mometasone, Phenylbutazone, Prednisolone, Rifampicin, Salicylic Acid, Theophylline at specified concentrations.
Precision (Within-Laboratory Precision):
A study was performed based on guidance from CLSI EP05-A3. Testing was conducted using 3 lots of the Quantia IgE reagent, 1 lot of the Quantia IgE Calibrator, 1 lot of the Quantia Ferritin/Myoglobin/IgE Control, and 1 instrument. Two controls, 1:1 mixture of control I and II, and 2 serum panels were tested in a minimum of 2 replicates, twice per day on 20 days.
Additional testing was conducted with 3 native serum pools using the same number of reagent, calibrator, and control lots and instruments utilized in the 20-day study. The 3 serum panels (Panel A, B, and C) were tested in a minimum of 2 replicates, twice per day on 12 days.
Key results for controls and panels:
Panel 50 IU/mL (n=80, Mean=53.4 IU/mL): Within-Run %CV = 3.9, Total %CV = 3.9
Control I (n=80, Mean=69.6 IU/mL): Within-Run %CV = 2.7, Total %CV = 2.8
1:1 Mix Control I and II (n=80, Mean=242.7 IU/mL): Within-Run %CV = 0.7, Total %CV = 1.0
Control II (n=80, Mean=418.0 IU/mL): Within-Run %CV = 0.6, Total %CV = 0.9
Panel 800 IU/mL (n=80, Mean=881.2 IU/mL): Within-Run %CV = 1.0, Total %CV = 1.3
Panel A (n=48, Mean=26.9 IU/mL): Within-Run %CV = 3.3, Total %CV = 4.9
Panel B (n=48, Mean=139.1 IU/mL): Within-Run %CV = 0.5, Total %CV = 1.3
Panel C (n=48, Mean=461.6 IU/mL): Within-Run %CV = 0.4, Total %CV = 1.2
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
February 21, 2023
Biokit, S.A. Angels Roma Regulatory Affairs & Design Quality Director Av. Can Montcau. 7 Llica d'Amunt, Barcelona 08186 Spain
Re: K214068
Trade/Device Name: Quantia IgE Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D, And E Immunological Test System Regulatory Class: Class II Product Code: DGC Dated: October 28, 2022 Received: October 31, 2022
Dear Angels Roma:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ying Mao -S
Ying Mao, Ph.D. Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K214068
Device Name Quantia IgE
Indications for Use (Describe)
Automated latex enhanced immunoassay for the quantitative in vitro determination of total immunoglobulin E (1gE) in human serum or plasma (EDTA, heparin, citrate) using the ARCHITECT c Systems. The measurement of total IgE is useful in the clinical diagnosis of IgE-mediated allergies, if used in conjunction with other clinical studies.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of 21 CER 807.92 and the Safe Medical Device Act of 1990.
| Submission Type | K214068 - Special 510(k) |
|---|---|
| Submitter's Information | Biokit, S.A. |
| Av. Can Montcau, 7 | |
| Lliçà d'Amunt, Barcelona 08186 | |
| Spain | |
| Contact Person | Àngels Roma |
| Quality & Regulatory Affairs VP | |
| Phone: +34 (938) 609-000 | |
| Email: aroma@werfen.com | |
| Preparation Date | February 11th, 2023 |
| Device Trade Name | Quantia IgE (IgE, Antigen, Antiserum, Control) |
| Regulatory Information | Regulation Number |
| 21 CFR 866.5510 | |
| Regulation Description | |
| Immunoglobulins A, G, M, D and E immunological test system | |
| Classification | |
| Class II | |
| Product Code | |
| DGC | |
| Classification Panel | |
| Immunology | |
| Predicate Device | K050493 |
| Quantia IgE | |
| Device Description | The Quantia IgE reagent is a suspension of polystyrene latex particles of uniform size coated with mouse anti-human IgE. When a sample containing IgE is mixed with the latex reagent and the reaction buffer included in the kit, agglutination occurs. The degree of agglutination is directly proportional to the concentration of IgE in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates. Methodology: Turbidimetric/Immunoturbidimetric. |
| Indications for Use / | |
| Intended Use | Automated latex enhanced immunoassay for the |
| quantitative in vitro determination of total | |
| immunoglobulin E (IgE) in human serum or plasma | |
| (EDTA, heparin, citrate) using the ARCHITECT c | |
| Systems. The measurement of total IgE is useful in the | |
| clinical diagnosis of IgE-mediated allergies, if used in | |
| conjunction with other clinical studies. |
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Description of the Modification: The sample volume that is used by the assay is changed from 3.5 µL to 10.5 µL. Due to this modification, additional changes have been implemented in the assay parameters: Read times are changed from 26-27 to 24-25, the Sample Probe water SmartWash is added and the lowlinearity is changed from 25.0 to 20.0 IU/mL. The correlation factor in the assay file is changed from 1.0000 to 1.0500. The changes to the Instruction for Use are detailed below.
| Current Insert Summary and Principle
(Excerpt) | Updated Insert Summary and Principle
(Excerpt)
Revisions in italic and highlights |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PRINCIPLES OF THE PROCEDURE | PRINCIPLES OF THE PROCEDURE |
| ---- (additional information is added) | For additional information on system and assay
technology, refer to the ARCHITECT System
Operations Manual, Section 3. |
| REAGENTS | REAGENTS |
| Reagent Kit | Kit Contents |
| ---- (additional information is added) | Volumes (mL) listed in the following table
indicate the volume per vial. |
| ---- (additional information is added) | Test per vial set 69 |
| | 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
ARCHITECT System Operations Manual, Section
10. |
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| ---- (additional information is added) | INSTRUMENT PROCEDURE | ||
|---|---|---|---|
| The Quantia IgE assay file must be installed on | |||
| the ARCHITECT c System prior to performing | |||
| the assay. | |||
| For detailed information on assay file installation | |||
| and viewing and editing assay parameters, refer | |||
| to the ARCHITECT System Operations Manual, | |||
| Section 2. | |||
| For information on printing assay parameters, | |||
| refer to the ARCHITECT System Operations | |||
| Manual, Section 5. | |||
| For a detailed description of system procedures, | |||
| refer to the ARCHITECT System Operations | |||
| Manual. | |||
| SPECIMEN COLLECTION AND HANDLING | SPECIMEN COLLECTION AND | ||
| PREPARATION FOR ANALYSIS | |||
| Suitable Specimens | Specimen Types | ||
| Serum: Use fresh serum collected by standard | |||
| venipucture techniques. Ensure complete clot | |||
| formation has taken place prior to | |||
| centrifugation. Centrifuge according to tube | Specimen Types | ||
| manufacturer's instructions to ensure proper | |||
| separation of serum blood cells. Gel separator | |||
| tubes were not tested. | *Serum Serum tubes | ||
| Some specimens, especially those from patients | |||
| receiving anticoagulant or thrombolytic | *Plasma Acceptable anticoagulants are: | ||
| therapy, may take longer to complete their | Sodium EDTA | ||
| clotting processes. Fibrin clots may | Potassium EDTA | ||
| subsequently form in these sera and the clots | |||
| could cause erroneous test results. | Sodium heparin | ||
| Plasma: Use plasma collected by standard | |||
| venipuncture techniques. The acceptable | |||
| anticoagulanants are sodium EDTA, potassium | |||
| EDTA, sodium heparin, lithium heparin, and | |||
| citrate. Ensure centrifugation is adequate to | |||
| remove platelets. Centrifuge according to tube | Lithium heparin | ||
| manufacturer's instructions to ensure proper | |||
| separation of plasma from bloods cells. Gel | Sodium citrate | ||
| separator tubes were not tested. | * Gel separator tubes were not tested. | ||
| For total sample volume requirements, refer to the | |||
| ASSAY PARAMETERS sections of this package | |||
| insert and Section 5 of the ARCHITECT System | |||
| Operations Manual. | Other specimen types, collection tube types, and | ||
| anticoagulants have not been verified with this | |||
| assay. | |||
| The instrument 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 in the assay. | |||
| Sample Matrix (Serum vs. Plasma) | |||
| Five sets of 52 paired samples were run. Sodium | |||
| EDTA plasma, potassium EDTA plasma, sodium | Sample Matrix (Serum vs. Plasma) | ||
| Forty paired samples were run. Sodium EDTA | |||
| plasma, potassium EDTA plasma, sodium |
6
| Slope | Y - Intercept | |
|---|---|---|
| Na-EDTA | 0.968 | |
| (95% CI: 0.963 to 0.973) | -1.553 | |
| (95% CI: -3.068 to -0.007) | ||
| K-EDTA | 0.982 | |
| (95% CI: 0.976 to 0.989) | -1.878 | |
| (95% CI: -3.873 to 0.117) | ||
| Na-Heparin | 0.978 | |
| (95% CI: 0.973 to 0.983) | -0.461 | |
| (95% CI: -1.983 to 1.060) | ||
| Li-Heparin | 0.978 | |
| (95% CI: 0.973 to 0.983) | -1.272 | |
| (95% CI: -2.761 to 0.218) | ||
| Citrate | 0.963 | |
| (95% CI: 0.955 to 0.972) | -2.226 | |
| (95% CI: -4.702 to 0.250) |
sodium citrate plasma paired to serum samples were used. The linear regression statistics are shown below.
| Slope | Y-Intercept | |
|---|---|---|
| Na-EDTA | 0.98 | |
| (95% CI*: 0.97 to 1.00) | -1.08 | |
| (95% CI: -3.83 to 1.47) | ||
| K-EDTA | 1.01 | |
| (95% CI: 0.99 to 1.03) | 0.80 | |
| (95% CI: -0.77 to 2.19) | ||
| Na-Heparin | 1.00 | |
| (95% CI: 0.98 to 1.01) | -1.22 | |
| (95% CI: -3.19 to 0.69) | ||
| Li-Heparin | 0.98 | |
| (95% CI: 0.98 to 1.00) | 1.23 | |
| (95% CI: -0.47 to 2.19) | ||
| Na-Citrate | 0.97 | |
| (95% CI: 0.96 to 0.99) | -0.74 | |
| (95% CI: -2.39 to 0.91) |
Specimen Storage
| Specimen Type | Temperature | Maximum Storage
Time | Special Instructions |
|---------------|-------------|-------------------------|------------------------------------------|
| Serum/Plasma | 20 to 25°C | 1 day | Specimens may be stored
on the clot. |
| Serum/Plasma | 2 to 8 °C | 2 days | |
| Serum/Plasma | -20°C | 12 days | Remove serum or plasma
from the clot. |
If testing will be delaved longer than the maximum 20 to 25°C or 2 to 8°C storage time, remove serum or plasma from the clot and store frozen (-20°C).
Each laboratory may establish a range around -20°C from either the freezer manufacturer's specifications or your laboratory standard operating procedure(s) for specimen storage.
NOTE: Stored specimens must be inspected for particulates. If present, mix and centrifuge the specimen to remove particulates prior to testing.
Specimen Shipping
Package and label specimens in compliance with applicable state, federal, and international regulations covering the transport of clinical specimens and infectious substances. Do not exceed the storage limitations listed above.
Specimen Storage
| Temperature | Maximum Storage | Bibliographic
Reference |
|-------------|-----------------|----------------------------|
| 20 to 25°C | 7 days | 8 |
| 2 to 8°C | 7 days | 8, 9 |
| -20°C | 6 months | 8 |
Guder et al.8 suggest storage of frozen specimens at -20°C for no longer than the time interval cited above. However, limitations of laboratory equipment make it necessary in practice for clinical laboratories to establish a range around -20°C for specimen storage. This temperature range may be established from either the freezer manufacturer's specifications or your laboratory standard operating procedure(s) for specimen storage.
NOTE: Stored specimens must be inspected for particulates. If present, mix and centrifuge the specimen to remove particulates prior to testing.
---- (additional information is added)
7
| PROCEDURE | PROCEDURE | ||||||
|---|---|---|---|---|---|---|---|
| Materials Required but not Provided | Materials Required but not Provided | ||||||
| ---- (additional information is added) | For information on materials required for | ||||||
| operation of the instrument, refer to the | |||||||
| ARCHITECT System Operations Manual, Section |
For information on materials required for
maintenance procedures, refer to the
ARCHITECT System Operations Manual, Section
9. | | | | | | |
| ---- (additional information is added) | Quality Control Guidance | | | | | | |
| | Refer to "Basic QC Practices" by James O
Westgard, Ph.D. for guidance on laboratory
quality control practices. | | | | | | |
| RESULTS | RESULTS | | | | | | |
| Refer to Appendix C of the ARCHITECT System
Operations Manual for information on results
calculations. | Calculation
For additional information on results
calculations, refer to the ARCHITECT System
Operations Manual, Appendix C. | | | | | | |
| ---- (additional information is added) | Interpretation of Results
As with all analyte determinations, the IgE value
should be used in conjunction with information
available from clinical evaluation and other
diagnostic procedures. | | | | | | |
| ---- (additional information is added) | Flags
Some results may contain information in the
Flags field. For a description of the flags that
may appear in this field, refer to the ARCHITECT
System Operations Manual, Section 5. | | | | | | |
| ---- (additional information is added) | Reportable Interval
Based on representative data for the limit of
quantitation (LoQ) and the limit of detection
(LoD), the ranges over which results can be
reported are provided below according to the
definitions from CLSI EP34, 1st ed. | | | | | | |
| Analytical Measuring Interval (AMI)a Units (IU/mL) 20.0 - 1000.0 Extended Measuring Interval (EMI)b 1000.0 - 10 000.0 a AMI: The AMI is determined by the range of
values in IU/mL that demonstrated acceptable
performance for linearity, imprecision, and | | | | | | | |
8
werfer
LIMITATIONS OF THE PROCEDURE
Refer to the SPECIMEN COLLECTION AND HANDLING and SPECIFIC PERFORMANCE CHARACTERISTICS
sections of this package insert.
No cross-reactivity studies have been conducted with heterophile antibodies.
There is no prozone interference for undiluted samples containing up to 26,000.0 IU/mL of IgE. Sample concentrations higher than 26,000.0 IU/mL have not been tested.
As the limit of quantification of Quantia IgE is 25.0 IU/mL, it is not recommended to use this test for children less than 12 months of age.
SPECIFIC PERFORMANCE CHARACTERISTICS
---- (additional information is added)
Linearity
Linearity was assessed according to Clinical and Laboratory Standards Institute (CLSI) protocol NCCLS EP6-A.12 The reportable range of the Quantia IgE assay is 25.0 to 1000.0 IU/mL.
b EMI: The EMI extends from the upper limit of quantitation (ULoQ) to the ULoQ x dilution factor. The value reflects a 1:10 dilution factor. NOTE: The default Low Linearity value of the assay file corresponds to the lower limit of the analytical measuring interval. Samples with an IgE value below the lower limit of the AMI are reported as Limit of Detection (LOD)
The LOD of the Quantia IgE assay is 12.9 IU/mL,
calculated by running 30 replicates of saline. LOD is
defined as the mean concentration of an analyte-free
sample + 2 SD, where SD is the within-run standard
deviation. | | | | | | | | | | | | | | | | |
| | IU/mL LoBa 6.2 LoDb 11.6 LoQc 20.0 a The LoB represents the 95th percentile from n ≥ 60 replicates of zero-analyte samples.
b The LoD represents the lowest concentration at which the analyte can be detected with 95% probability based on n ≥ 60 replicates of low-analyte level samples.
c The LoQ is defined as the lowest concentration at which a maximum allowable precision of 20 %CV and a maximum allowable bias of 20% were met and was determined from n ≥ 60 replicates of low-analyte level samples and where the assay is linear. | | | | | | | | | | | | | | | |
| Interfering Substances
...
Rheumatoid factor interference is less than 10% up to 138 IU/mL.
For a comprehensive review of interfering substances, refer to the publication by Young et al.13 | Interfering Substances
...
Potentially Interfering Endogenous Substances
A study was performed based on guidance from CLSI EP07-A2. and CLSI EP37, 1st ed. Each substance was tested at 1 analyte level (approximately 90.0 IU/mL). | | | | | | | | | | | | | | | |
| | No Significant Interference (Interference within ± 5%) Potentially Interfering Substance Interferent Level
(mg/dL) Bilirubin (conjugated) 40 Bilirubin (unconjugated) 40 Hemoglobin 1000 Lipemia (chyle) 2.4 AU/cm at 660 nm Lipemia (triglyceride) 1500 | | | | | | | | | | | | | | | |
| | Potentially Interfering Other Substances
A study was performed based on guidance from CLSI EP07-A2, CLSI EP07, 3rd ed. and CLSI EP37, 1st ed. | | | | | | | | | | | | | | | |
| | No Significant Interference (Interference within ± 10%) Potentially Interfering
Substance Interferent
Concentration IgE Target
(IU/mL) % Difference HAMA 0.100 mg/dL 99.0 0.4 RF 138 IU/mL 90.0 1.3 | | | | | | | | | | | | | | | |
| | Potentially Interfering Drugs
A study was performed based on guidance from CLSI EP07-A2 and CLSI EP37, 1st ed. Each | | | | | | | | | | | | | | | |
10
werten
Precision
The precision of the Quantia IgE assay is