Total IgE FIA Test | F5020 | Serum, Plasma, Whole Blood

For in vitro diagnostic use only. For professional use only. Step 3: For Plasma/Serum only: Test specimens immediately after
INTENDED USE collection or store refrigerated at 2-8°C for up to 5 days.
Specimens can be frozen at -20°C for longer storage. Avoid
The Total Immunoglobulin E (IgE) Fluorescence ImmunoAssay (FIA) multiple freeze-thaw cycles.
Test is a lateral flow chromatographic fluorescence immunoassay for the
Prior to testing, bring frozen specimens to room temperature
quantitative detection of IgE in human serum, plasma, or whole blood
slowly and mix gently. Specimens containing visible particulate
using the RaFIA Immunofluorescence system. This test is intended for
matter should be clarified by centrifugation before testing.
in vitro diagnostic use only.
Note: Do not test specimens demonstrating gross lipemia, gross
SUMMARY AND EXPLANATION OF THE TEST
hemolysis or turbidity in order to avoid interference with result
Immunoglobulin E (IgE) is an antibody synthesized by the immune interpretation.
system in response to a perceived threat. IgE plays an essential role in
type I hypersensitivity, and it is also associated with allergic responses, ASSAY PROCEDURE
including asthma, and to a lesser degree with immunity to parasites [1]. Read these instructions and the instrument manual carefully before
testing.
Total IgE levels vary according to the likelihood of a patient having one
or more allergies. Allergen-specific IgE levels will increase after Please refer to the user manual of the RaFIA Immunofluorescence
exposure and then decline over time. An elevated level of total IgE Analyzer and RaFIA Immunofluorescence Incubator for details.
indicates that an allergic response is likely to be present, but it will not
Step 1: Bring the specimen and detection buffer to room temperature. If
show which allergy the patient has.
the specimen is stored frozen, thaw and mix well prior to
In general, the more allergies a patient has, the higher the total IgE performing the assay.
levels are. An IgE elevation can also indicate a parasitic infection but Step 2: Turn on the incubator. Set the incubation temperature to 25°C
cannot be used to determine the type of infection [2]. and incubation time to 12 minutes.
TEST PRINCIPLE
Step 3: Turn on the analyzer and insert SD card into the analyzer. Press
This test is a fluorescent lateral flow immunoassay. When the specimen “Test” and choose “Quick Test”. Input the patient information,
and the buffer are mixed and applied into the test device, the IgE present then press “Confirm”.
in the specimen and the mouse anti-IgE monoclonal antibody labeled
Step 4: When ready to test, open the pouch and label the device with
with fluorescent reporters form an intermediate complex. The
the specimen’s ID number. Ensure that the lot number of the
intermediate complex moves along the nitrocellulose membrane by
buffer and the test device match.
lateral flow to a detection line (T-line) coated with IgE specific
monoclonal antibodies. The intermediate complex will be captured by Note: Complete steps 5 and 6 within 1 minute to ensure the accuracy of
the antibodies coated on the T-line to form the final fluorescent reaction the test results.
compound sandwich. Thus, the fluorescent signal on the detection line Step 5: Add 20 μL of serum/plasma, or 30 μL of whole blood into the
is positively correlated with the concentration of IgE in human serum, buffer tube. Mix the specimen well with detection buffer by
plasma, or whole blood. tapping or inverting the tube.
The fluorescent signal from the reporters of the compound sandwich will Step 6: Load 80 μL of specimen mixture into the sample well of the
be detected and calculated according to the calibration curve in the device. Ensure that there are no air bubbles. Immediately insert
secure digital (SD) card (provided with the reagents), to represent the the device into the incubator and incubate for 12 minutes.
concentration of IgE in human specimens.
Step 7: After 12 minutes, pull out the test device, insert it into the
REAGENTS AND MATERIALS PROVIDED analyzer and press “Start Test”. The test result will be shown on
1. Individually sealed foil pouches containing: the screen and print automatically.
a. One test device Step 8: Discard used devices after interpreting the result following local
b. One desiccant requirements governing the disposal of devices.
2. Detection buffer tubes
3. SD card QUALITY CONTROL
4. Instructions for Use Quality control tests are a part of good testing practices to confirm the
MATERIALS REQUIRED BUT NOT PROVIDED expected results and validity of the assay, and should be performed at
regular intervals or:
1. Clock or timer
2. RaFIA Immunofluorescence Analyzer • After opening a new test lot to ensure the test performance is
3. RaFIA Immunofluorescence Incubator not altered.
REAGENT PREPARATION AND STORAGE INSTRUCTIONS • Whenever there is any question concerning the validity of the
test results.
All reagents are ready to use as supplied.
1. Store the detection buffer and test device at 2-30°C. Control materials are not provided with this kit. For more information
2. Use the test device within 30 minutes after opening the pouch. regarding obtaining the control materials, contact CTK Biotech’s Sales
Division for assistance (Please refer to the instructions for use of control
SPECIMEN COLLECTION AND HANDLING material).
Consider any materials of human origin as infectious and handle them INTERPRETATION OF ASSAY RESULT
using standard biosafety procedures.
Expected Values
Step 1: Collect venous blood by venipuncture into a collection tube
containing EDTA, citrate or heparin for plasma or whole blood The following normal range is recommended. However, laboratories
specimens, or a collection tube containing no anticoagulants for should establish their own diagnostic cut-off concentration based on the
serum specimens. clinical practice at their respective institutions.
Step 2: For whole blood: Test immediately or store refrigerated at 2- Normal Reference Value
Age (years)
8°C for up to 24 hours after collection. Do not freeze specimens. IU/mL ng/mL
Neonates 1.5 3.6
For plasma: Centrifuge the collected specimen and carefully <1 15.0 36.0
withdraw the plasma into a new pre-labeled tube. 1-5 60.0 144.0
For serum: Allow blood to clot, centrifuge the collected specimen 6-9 90.0 216.0
and carefully withdraw the serum into a new pre-labeled tube. 10-15 200.0 480.0
≥16 100.0 240.0

Copyright 2021 by CTK Biotech, Inc.

PERFORMANCE CHARACTERISTICS result must be carefully evaluated when patients are known to have
1. Range these antibodies [3, 4].

Working range: 1.0-1000.0 IU/mL 3. If the symptoms are highly suspicious or persist, while the result
from the Total IgE FIA Test is normal or non-reactive, it is
2. Precision recommended to test with an alternative test method.
Intra-lot Precision 4. Some unknown factors may interfere with the test and cause
Intra-lot precision was determined by testing of IgE reference erroneous results, such as technical/procedural errors, degradation
materials using 10 test devices from the same lot. CV ≤ 15%. of the test components/reagents or presence of interfering
substances in the specimens.
Inter-lot Precision
Inter-lot precision was determined by testing of IgE reference 5. The Total IgE FIA Test should be considered a preliminary
materials using 30 test devices from 3 consecutive lots randomly diagnostic tool only. In case of an abnormal result, consult a
(10 test devices from each lot). CV ≤ 15%. physician to discuss the test result and decide further course of
action.
3. Accuracy
REFERENCES
IgE control materials with three different concentrations were
tested by every lot of test device, and the deviations were within 1. Erb KJ et al. (2007). Helminths, allergic disorders and IgE-
±15%. mediated immune responses: where do we stand? Eur. J.
Immunol., 37(5): 1170–1173.
4. Linearity
2. Gould HJ, Sutton BJ, Beavil AJ, Beavil RL, McCloskey N, Coker
A serial concentration of IgE reference materials at 1.0-1000 IU/mL HA, Fear D, Smurthwaite L. (2003). The biology of IgE and the
was tested, and the correlation coefficient (R) is ≥ 0.9900. basis of allergic disease. Annu. Rev. Immunol., 21: 579–628.
5. Specificity 3. Hansen, H. J., Sharkey, R. M., Sullivan, C. L., & Goldenberg, D. M.
No cross reactivities were observed while testing following (1993). HAMA interference with murine monoclonal antibody-
immunoglobulins with indicated concentrations: based immunoassays. J. Clin. Immunoassay, 16(4), 294-299.
Immunoglobulins Concentrations Test Results 4. Levinson, S. (1992). The nature of heterophilic antibodies and their
IgG 200 mg/mL ≤ 1.0 IU/mL role in immunoassay interference. J. Clin. Immunoassay, 15, 108-
IgA 20 mg/mL ≤ 1.0 IU/mL 115.
IgM 20 mg/mL ≤ 1.0 IU mL
Index of Symbols
WARNINGS AND PRECAUTIONS Consult For in vitro
instructions for use diagnostic use only Use by
For in vitro diagnostic use only. For professional use only.
Catalog # Lot Number Tests per kit
1. Read these instructions completely before performing the test.
Failure to follow the instructions could result in inaccurate test Store between 2-30°C Do not reuse
results.
Manufacturer Date of manufacture
2. Do not open the sealed pouch unless ready to conduct the assay.
Do not use if the pouch is damaged or not sealed. Do not use
expired devices.
S IMPLIFYING DIAGNOSTICS

3. Lot number of buffer and test device must match. CTK Biotech, Inc.
13855 Stowe Drive
4. Bring all reagents to room temperature (15-30°C) before use. Poway, CA 92064 USA
Tel: 858-457-8698
5. Do not use components from any other type of kit as a substitute for Fax: 858-535-1739
the components in this kit. Use the Total IgE FIA Test in conjunction E-mail: info@ctkbiotech.com
with CTK RaFIA instruments only. PI-F5020 Rev. B1.0
Date released: 2021-05-03
6. Do not use hemolyzed blood specimens for testing. English Version
7. Wear protective clothing and disposable gloves while handling
For Export Only. Not For Resale in the USA.
the kit reagents and clinical specimens. Wash hands thoroughly
after performing the test.
8. Follow the US CDC Universal Precautions for prevention of
transmission of HIV, HBV and other bloodborne pathogens.
9. Do not smoke, drink or eat in areas where specimens or kit reagents
are being handled.
10. Dispose of all specimens and materials used to perform the test as
bio-hazardous waste.
11. Read test results at 12 minutes after a specimen is applied to the
sample well of the device.
12. Do not perform the test in a room with strong air flow, i.e. an electric
fan or strong air-conditioning.
LIMITATIONS OF TEST
1. Follow the assay procedure and the interpretation of assay result
sections closely when testing for the presence of elevated IgE in
serum, plasma, or whole blood from individual subjects. Failure to
follow the procedure may give inaccurate results.
2. Human anti-mouse antibody (HAMA) may be present in patients
who have received immunotherapy with a murine monoclonal
antibody. This kit has been specially designed to minimize the
effect of these antibodies on the test results. However, the test
Copyright 2021 by CTK Biotech, Inc.
.