This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Notification No. 13A2X00197218031**Revised: January 2017 (4th edition)*Revised: April 2008 (3rd edition)

This package insert must be read carefully prior to use.
Immunoglobulin M assay kit for blood tests(Classification No.: 30234001)

IgM in sample + IgM antiserum
Antigen-antibody precipitate
2. Features
1) Ready-to-use reagents do not require sampledilution.
2) There is no prozone phenomenon within theusual measurement range.
3) Applicable to various automated analyzers.

Pureauto S IgMGeneral Precautions
1. This product is for in vitro diagnostic use, andmust not be used for any other purposes.
2. Clinicians should make a comprehensive clinicaldecision based on assay results in conjunction withclinical symptoms and other examination results.
3. This product should be used only as directed in thispackage insert. Reliability of results cannot beguaranteed if there are any deviations from theinstructions in this package insert.
4. If the reagent accidentally comes in contact witheyes and/or mouth, rinse immediately with ample
water as first aid, and consult the doctor ifrequired.
5. Carefully read the operating instructions for eachtype of automated analyzers prior to using thisproduct. Parameters for each type of analyzers areavailable, and can be requested from SEKISUIMEDICAL CO., LTD. if required.
6. Perform a quality control test prior to assay toensure accuracy.

＊＊

Procedural Precautions ＊1. Properties of Samples and Sampling Methods
1) Samples
Serum or plasma may be used.
2) Storage of samples1)
The isolated serum or plasma should be testedon the same day.
Store samples at -20°C or lower.
Bring samples to room temperature (15–30C)
before use.
2. Interfering substances
Assay results are not affected by free bilirubin (upto 40 mg/dL), conjugated bilirubin (up to 40mg/dL), or hemoglobin (up to 1000 mg/dL).
3. Others
1) Always use GAM complement calibrator
for calibration.
2) Precautions for assay range
If the concentration of sample exceeds assay
range, dilute the sample with saline and repeat
the measurement.

Description (Kit Components) ＊＊Component: Ingredients
IgM Buffer Solution 1:
2-Amino-2-hydroxymethyl-1,3-pr
opanediol Buffer Solution
IgM Antibody Solution 2:
Anti-human immunoglobulin M
goat antiserum

Dosage/Administration (Assay Procedure) ＊＊1. Preparation of reagents
Reagent (1): IgM Buffer Solution 1 is ready touse.
Reagent (2): IgM Antibody Solution 2 is readyto use.
2. Assay Procedure
This product is compatible with various types ofautomated analyzer. An example of the assay
procedure is indicated below.

Intended Use
Measurement of immunoglobulin M in serum orplasmaImmunoglobulins are produced by B cells including
plasma cells as a host defense against viruses,bacteria, etc. or in response to stimulation by drugs,
tissue antigens, etc., and play a very important role inhumoral immunity.
Because serum/plasma immunoglobulin levels showchanges in patients with viral/bacterial infections,reticuloendothelial abnormalities, impaired hepaticfunction, etc., measurement of IgM is important forthe diagnosis and follow-up of infections, immune
diseases, and liver disorders.

37CSample + Reagent (1)3 μL
200 μL5 min
Reagent (2) 37C80 μL

5 min

Measurement(Absorbance I※)
Measurement(Absorbance II※)
Calculation ofconcentration※

Absorbance I and II: The difference in absorbance
between 800 nm and 340 nm.
Calibration material: GAM complement calibrator(manufacture's assigned value)
Reagent blank: Purified water or saline

Assay Principle
1. Assay Principle
Immunoglobulin M (IgM) in samples undergoes
an antigen-antibody reaction with anti-humanimmunoglobulin M goat antiserum (IgMantiserum), resulting in turbidity. The IgM contentof the sample is determined by measuring theturbidity.

Assessment of Assay Results
1. Reference standard range2)
Male:
33–190 mg/dL
Female: 46–260 mg/dL
2. There may be reactions or interfering reactions

1

with non-target substances. If assay results appear
to be unreliable, repeat the measurement (ifnecessary, after dilution) or try another analyticalmethods.
Performance
1. Sensitivity
1) Reagent blank: absorbance being equal to or
lower than 0.25
2) Sensitivity: The absorbance is 0.16–0.60 per
100 mg/dL of IgM.
2. Accuracy: 90–110 % of the expected assay value
3. Within-run Reproducibility:
Coefficient of variation ≤ 5 %(Test methods used for 1.–3. are in-housemethods.)
4. Measurement Range3): (On Hitachi 7170
automated analyzer)
1–500 mg /dL
5. Correlation3)
1) Serum N=50
r=0.999
y=0.96x+4.8
Control method: Approved in vitro diagnostic(turbidimetric immunoassay)
2) Plasma N=50
r=0.996y=0.998x–7.2
Control method: Approved in vitro diagnostic(turbidimetric immunoassay)
6. Standard Material
CRM470（IRMM）＊＊Precautions for Use or Handling ＊1. Precautions for Handling (to Ensure Safety)
1) All samples used in the test should be handled
as a material possibly infected with HIV, HBV,HCV, or other viruses. To prevent infection, use
disposable gloves and avoid mouth pipetting
during the test.
2) Proclin 300, which possesses skin-irritative
potential, is added as an antiseptic agent in theIgM Buffer Solution 1 and IgM Antibody
Solution 2. Therefore, if the reagent comes incontact with skin or clothes, rinse immediately
with ample water, and consult the doctor if skinirritation develops.
2. Precautions for use
1) This product should be stored as directed,
without freezing. Freezing can deteriorate thereagents, which can produce inaccurate results.
Therefore, avoid using the reagents which havebeen previously frozen.
2) Do not use expired reagents. Use of suchreagents cannot guarantee the reliability ofmeasurement values.
3) Do not replenish the reagents.
4) Do not perform the assay under direct sunlight
3. Precautions for Disposal
1) Before disposal, used samples and theircontainers must be immersed in sodium
hypochlorite solution at a concentration ofgreater than 0.1% for longer than 1 hour or
autoclaved at 121ºC for 20 minutes.
2) To prevent infections from spilled samples orsolutions containing samples, wipe the spilledarea thoroughly with disinfectants such as
sodium hypochlorite solution at a concentrationof greater than 0.1 %.
3) The reagents and treated samples should bediscarded as medical waste or industrial waste
according to the waste disposal regulations.
4) The reagents should be disposed of inaccordance with the Water Pollution Control act
or related regulations.
4. Other precautionsDo not use the containers for other purposes.
Storage and Shelf Life ＊＊1. Storage temperature: 2–10 C
2. Shelf life: 1 year from the date of manufacture(The expiration date is printed on the outerpackage.)
Packaging
NamePackage
IgM Buffer(1)
2 × 40 mL
Solution 1
Pureauto S
IgM
IgM Antibody(2)
2 × 8 mL
Solution 2
Constituent reagents are available in otherconfigurations. For further details please contact
SEKISUI MEDICAL CO., LTD.
References ＊1) Medical Practice Editorial Board: Laboratory test
guide revised in 2015, Bunkodo, 683, 2015.
2) Saito K., Kawai T., Ichihara K.: Jpn J Clin Pathol(extra edition), 101, 118, 1996.
3) In house data, SEKISUI MEDICAL CO., LTD.
Contact ＊SEKISUI MEDICAL CO., LTD.
international@sekisui.com＊＊＊

Manufacturer
SEKISUI MEDICAL CO., LTD.
1-3, Nihonbashi 2-chome, Chuo-ku, Tokyo, Japan