This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Approval No. 20900AMZ00373000*Revised: January 2017 (4th edition)
Completely revised: April 2014 (3rd edition)

This package insert must be read carefully prior to use.
Treponema antibody assay kit

2) Assay results may be affected by chyle. Ifchylemia is seen in the sample, centrifuge thesample (at 2000g or more for 10 minutes)
before use.
3. Others
1) Always use TPLA standard solution forcalibration.
2) Precautions for assay range
If the concentration of sample exceeds assay
range, dilute the sample with saline and repeat
the measurement.

MEDIACE TPLA(A)(M)
General 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.

Dosage/Administration (Assay Procedure) ＊1. Preparation of reagents
Reagent (1): Sample Dilution Buffer is ready touse.
Reagent (2): Latex Suspension is ready to use.
Before use, gently invert either Reagent (1) or(2) bottle to mix it thoroughly, and check that
there are no bubbles.
2. Assay Procedure
This product is compatible with various types ofautomated analyzer. An example of the assay
procedure is indicated below.
Sample + Reagent (1)16 μL
175 μL

Description (Kit Components)
1. Sample Dilution Buffer
Phosphate buffer solution containing bovine
serum albumin
2. Latex Suspension
Treponema pallidum antigen-coated latex

Reagent (2)25 μL※

37C
5 min
37C
50–240 sec

Measurement(Absorbance※)

Absorbance: The change of absorbance at 700 nm

from approximately 50 seconds to 240 seconds.
Calibration material: TPLA standard solution(manufacture's assigned value)

Intended Use
Measurement of anti-Treponema antibody inserum or plasma(Aid in diagnosis of Treponema Pallidum infection)

Assessment of Assay Results
1. Assessment of Assay Results
When the result obtained by using this product is≥ 10 T.U.,Note the sample is judged to be positive.
Note: T.U. is the abbreviation for TITER UNITS,
which is a unit for the anti-treponema antibody
titer measured using this product. Proceed withthe WHO Standard (The International Standardfor Syphilitic Human Serum [first internationalstandard preparation] established in 1958): 1 T.U.
is equal to 2 mIU.
2. When the assay result is positive using this product,
perform further tests and interpret the results by
taking the results of other examinations and thepatient’s symptoms into consideration.
3. Clinicians should make a comprehensive clinicaldecision based on assay results in conjunction
with clinical symptoms and other examination
results. Do not make a diagnosis based on theresults obtained with this product alone.
4. When a false-positive assay result due to anonspecific reaction is suspected, perform
additional tests such as the FTA-ABS test andmake a final decision by also considering theAssay Principle
A sample is reacted under certain conditions with
Treponema
Pallidum
antigen-coatedlatex,
consequently anti-Treponema antibody in the sample
causes agglutination of the latex. The anti-Treponema
antibody titer in the sample is determined from theincrease of turbidity due to formation of aggregates,
which is calculated as the difference between theturbidity of the sample before and after reaction.
Procedural Precautions ＊1. Properties of Samples and Sampling Methods
1) Samples: Serum and plasma (heparin plasmaand EDTA plasma) may be used.
2) Samples should be tested while fresh.
3) Handle the samples carefully to prevent
infection
2. Interfering substances
1) Assay results are not affected by bilirubin (upto 20 mg/dL), hemoglobin (up to 500 mg/dL),or rheumatoid factors (up to 500 IU/mL).

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patient’s symptoms and medical history.
5. Serum (plasma) samples from patients in the earlystage of the antibody response or with impaired
antibody production due to compromised immune
function contain a low antibody titer and the test
may be negative.
6. Nonspecific reactions may occur when serum(plasma) samples from patients with autoimmune
diseases are tested. Clinicians should make acomprehensive clinical decision by also assessing
the results of other examinations and the patient’ssymptoms.
7. Caution must be exercised, because false-positive
assay results may be obtained with serum(plasma) samples from patients who havereceived
blood
products
containing
immunoglobulins.
8. Pay attention to the prozone phenomenon, because
it generally occurs in immune responses.

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) Sodium azide is added as an antiseptic agent inthe Sample Dilution Buffer and Latex
Suspension. Therefore, if the reagent comes in
accidentally contact with eyes, mouth or skin,rinse immediately with ample water as first aid,
and consult the doctor if required.
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) After completion of measurement, this productshould be stored as directed in a tightly-stoppedcontainer.
5) Do not mix materials from different kit lotnumbers.
6) Prepare a new calibration curve for every assay.
Do not change the bottle of Sample Dilution
Buffer or Latex Suspension or start to use
products from different lots during the assay.
7) 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 121 ºC 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.
5) Sodium azide has been added as an antiseptic
agent in the Sample Dilution Buffer and Latex
Suspension. It can react with lead or copper
pipes to produce the highly explosive metalazide. Therefore, the reagent should be flushedwith large amounts of water during disposal.
4. Other precautions
Do not use the containers for other purposes.

Performance ＊1. Performance
When used in accordance with the standard
testing method specified by the manufacturer, theperformance of this product is as follows.
1) Sensitivity(1) Change of turbidity in normal humanserum (negative for syphilis): < 0.01
(2) Proceed with positive control serum ofaround 450 T.U.: the change of turbidity
is within the range of 0.10–0.70.
2) Accuracy
Proceed with control serum having a known
concentration: the result obtained with all
positive reference serum samples is > 10 T.U.
of the known concentration. The result
obtained with all of the negative control serum
samples is < 10 T.U. of the known
concentration.
3) Within-run reproducibility
Test the positive control serum with a known
concentration 10 times simultaneously: thecoefficient of variation (C.V.) of the change inturbidity is ≤ 15%.
4) Measurement range2)
The measurement range of this product is 5–
250 T.U. (on Hitachi 7170 automatedanalyzer).
If the anti-treponema antibody titer in asample exceeds 250 T.U., dilute the sample
with physiological saline or another suitablereagent and perform re-measurement.
2. Correlation1), 2)
1) Serum N=171
r=0.828
y=106x+10.5
Control method: Approved in vitro diagnostic(Treponema Pallidum hemagglutination assay)
2) Plasma Lithium heparin plasma
N = 74, r = 0.998, y = 1.03x+0.03
Control method: Values obtained by using thisproduct to test serum collected simultaneously EDTA-2K plasma
N = 74, r = 0.998, y = 0.96x + 0.38
Control method: This product (Comparisonwith serum samples obtained simultaneously)

Storage and Shelf Life ＊1. Storage temperature: 2–8 C (avoiding freezing)
2. Shelf life: 1 year (indicated on the outer box andthe container)

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Packaging
1.MEDIACE TPLA（A）
Reagent Name
Package
Sample Dilution Buffer
4 × 18 mL
Latex Suspension
1 × 10 mL
2.MEDIACE TPLA（M）
Reagent Name
PackageSample Dilution Buffer
2 × 49 mL
Latex Suspension
1 × 14 mL
Constituent reagents are available in otherconfigurations. For further details, contact SEKISUIMEDICAL CO., LTD.
References
1) Osato K. et al.: Clinical evaluation of latex
agglutination test kits for detecting anti-syphilitic
lipoidal antibodies and anti-treponemal antibodies,Japanese Journal of Sexually Transmitted
Infections, 13, 124–130, 2002.
2) 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, Japan3