This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Approval No. 21200AMZ00424000**Revised: June 2022 (5th edition)*Revised: January 2017 (4th edition)

This package insert must be read carefully prior to use.
Non-treponemal lipid antibody assay kit

2) Samples should be tested while fresh.
3) Handle the samples carefully to prevent
infection.
2. Interfering Substances or Drugs
1) Assay results are not affected by free bilirubin(up to 19.7 mg/dL), conjugated bilirubin (up to21.0 mg/dL), hemoglobin (up to 488 mg/dL),rheumatoid factors (up to 450 IU/mL), orheparin (up to 30 IU/mL).
*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.

MEDIACE RPR
General Precautions
1. This product is for in vitro diagnostic use only, andmust not be used for any other purposes.
2. Clinicians should make a comprehensive clinicaldecision based on consideration of the assay results
together with the patient’s symptoms and theresults of other examinations.
3. The reliability of results cannot be guaranteed if
this product is used for purposes or testing is doneby methods other than those stated in this package
insert.
4. Before use, be sure to read the package insert andthe user’s manual for the automated analyzer.
Contact the manufacturer for further details.
Analyzers should be cleaned before use to ensure
accurate calibration.
5. RPR Standard Serum contains human-derivedcomponents. The reagent should be consideredpotentially infectious and handled with great carein the same manner as the samples.

Dosage/Administration (Assay Procedure)
1. Preparation of reagents
1) Buffer Solution
Gently invert the Buffer Solution bottle to mix
it thoroughly and then use the solution as it is.
2) Latex Suspension
Gently invert the Latex Suspension bottle tomix it thoroughly and then use the solution as
it is.
3) RPR Standard Serum
Gently invert the RPR Standard Serum bottle
to mix it thoroughly and then use the solution
as it is.
2. Assay Procedure
Perform the assay according to the instructions for
operating the automated analyzer. Refer to theMethod Sheet for the details of the assay method.
Contact SEKISUI MEDICAL CO., LTD. for
information about the parameters for otherautomated analyzers.
1) Preparation of the calibration curve
Mix the RPR Standard Serum, Buffer
Solution, and Latex Suspension to start thereaction. Prepare a calibration curve bymeasuring the difference of turbidity (changeof turbidity) at predetermined times.
2) Sample measurement
Measure the change of turbidity by following
the procedure described in “Preparation of thecalibration curve”, and determine the anti-lipid
antibody titer in the sample from thecalibration curve.
3) Parameters (on Hitachi 7170 automatedanalyzer)(1) Mix 180 μL of Buffer Solution and 20 μLof the sample, and warm forapproximately 5 minutes at 37 °C.
(2) Add 60 μL of the Latex Suspension to themixture and warm the mixture at 37 °C.
(3) Then measure the change of turbidity at awavelength of 700 nm from approximately
50 seconds to 4 minutes.
(4) Prepare a calibration curve by measuring
the change of turbidity in each standard
solution by the same procedure as for thesample, and determine the anti-lipidantibody titer from the change of turbidity.

Description (Kit Components)
1. Buffer Solution
Phosphate buffer solution containing bovine
serum albumin*2. Latex Suspension
Lipid antigens (cardiolipin and lecithin) coatedlatex
3. RPR Standard Serum (5 concentrations) (soldseparately) Note1
RPR-positive human serum
Note 1: Contains human-derived serum. Refer to “1.
Precautions for Handling (to EnsureSafety)” in the “Precautions for Use orHandling” section for further details.
Intended Use
Measurement of syphilis anti-lipid antibody in serumor plasma(Aid in diagnosis of treponema pallidum infection)
Assay Principle
A sample is reacted under certain conditions with
polystyrene latex coated by lipid antigens (cardiolipinand lecithin), consequently syphilis anti-lipid
antibody in the sample causes agglutination of thelatex. The syphilis anti-lipid antibody titer in thesample is determined from the increase of turbidity
due to formation of aggregates, which is calculated as
the difference between the turbidity of the sample
before and after reaction (change of turbidity).
Procedural Precautions
1. Properties of Samples and Sampling Methods**1) Use serum or plasma (heparin plasma) as thesample.

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Control method: Approved in vitro diagnostic(RPR card method)
2) Plasma N=88
r=0.995
y=1.03x+0.05
Control method: This product (Comparison withserum samples obtained simultaneously)

Assessment of Assay Results
1. Assessment of assay results
When the result obtained by using this kit is ≥ 1
R.U. Note2, the sample is judged to be positive.
Note2: R.U. (RPR units) is based on the WHO
Standard (The International Standard for
Syphilitic Human Serum [first internationalstandard preparation] established in 1958): 1
R.U. is equal to 0.4 IU. One R.U. isequivalent to the value obtained by using theRPR card method.
2. When the assay result is positive, perform further
tests and interpret the results by other related tests,
and take the symptoms into consideration.
3. Clinicians should make a comprehensive clinicaldecision based on assay results in conjunction withclinical symptoms and other examination results.
Do not make a diagnosis based on the results
obtained with this kit alone.
4. Serum (plasma) samples from patients in the earlystage of the antibody response or with impaired
antibody production due to compromised immune
function may contain a low antibody titer and thetest may be negative.
5. 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 tests and the patient’ssymptoms.
6. Caution must be exercised, because false-positive
assay results may be obtained with serum (plasma)
samples from patients who have received blood
products containing immunoglobulins.
7. Pay attention to the prozone phenomenon (hookeffect), since it generally may occur in immune
responses.

Precautions for Use or Handling
1. Handling (to Ensure Safety)
1) All samples used in the test should be handled
as a material possibly infected with viruses suchas HIV, HBV, or HCV or other pathogens. The
ingredient of the RPR Standard Serum ishuman-derived. The Standard Serum has been
confirmed to be negative for HIV antibody, HBs
antigen, and HCV antibody. However, thepresence of pathogens (including thosementioned above) cannot be excluded, so it
should be handled with care using disposable
gloves, protective glasses, and a gown in thesame way as the samples. To prevent infection,
avoid mouth pipetting.
2) Do not eat, smoke, apply cosmetics, or touchcontact lenses in the assay area where samples
and reagents are being handled.
3) Buffer Solution, Latex Suspension, and RPRStandard Serum contain sodium azide at aconcentration of 0.1% or lower as apreservative. If any of these reagents accidently
comes into contact with the eyes or skin,
implement first-aid measures such as rinsing thearea with water and seek medical treatment ifnecessary.
4) To prevent transmission of infection fromspilled samples or solutions containing samples,
wipe the spilled area thoroughly with sodium
hypochlorite solution at a concentration of 0.1%
or more.
2. Precautions for use
1) This product should be stored as directed. Avoid
freezing. Do not use any reagent that has been
stored under conditions other than thosespecified (such as in a freezer) or has expired.
2) Do not combine or mix different lots of theBuffer Solution or Latex Suspension.
3) Prepare a new calibration curve for each assay.
Do not change the bottle or lots of Buffer
Solution or Latex Suspension during the assay.
4) Use the thermostat of the analyzer to ensure
even distribution of the reaction temperature.
5) Check the reagent bottle and its label before
use. Do not use the reagent if the label has
peeled off or if it is smudged or illegible.
3. Precautions for Disposal
1) Sterilize or disinfect any waste created during
the assay in the same way as for the samples
and reagents. Such waste should be disposed ofin accordance with the regulations establishedby each prefecture, such as the Waste Disposaland Public Cleansing Act and the Water
Pollution Prevention Act.
2) Dispose of the used containers as medical orindustrial waste in accordance with theregulations for handling medical or industrialwaste.
3) The reagents contain sodium azide that may
react with lead or copper pipes and produce
highly explosive metallic azide. When washing

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
The change of turbidity (ΔAbs) per 1 R.U. of
syphilis anti-lipid antibody is ≥ 0.0100 higher
than that (ΔAbs) under blinded conditions.
2) Accuracy
Proceed with control serum that has a known
syphilis anti-lipid antibody titer: the result iswithin the range from 80–120% of the known
antibody titer.
3) Within-run reproducibility
Test each of 2 types of control serum withdifferent syphilis anti-lipid antibody titers 10
times simultaneously: the coefficient ofvariation (CV) of the measurements is ≤ 15%.
4) Measurement range2)
The measurement range of this kit is 0.2–8R.U. (on Hitachi 7170 automated analyzer).
If the syphilis anti-lipid antibody titer in asample exceeds 8 R.U., dilute the sample withphysiological saline or another suitablereagent and perform re-measurement.
2. Correlation1), 2)
1) Serum N=82
r=0.909y=1.01x+0.35

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reagents off the skin or if reagents are
accidentally discarded, take appropriate
measures (e.g., flush copiously with water).
Storage and Shelf Life
1. Storage temperature: Store at 2–8 °C (avoidingfreezing)
2. Shelf life: 6 months (indicated on the outer boxand the container)
Packaging
1. MEDIACE RPR (A)Reagent name
Package contents
Buffer Solution
2 × 18 mL
Latex Suspension
1 × 12 mL
2. MEDIACE RPR (M)Reagent name
Package contents
Buffer Solution
1 × 60 mL
Latex Suspension
1 × 20 mL
Constituent reagents are available in otherconfigurations. For further details, contact
SEKISUI MEDICAL CO., LTD.
3. Sold separately
Reagent name
Package contents
RPR Standard Serum1 × 1 mL
(5 concentrations)× 5 concentrationsReferences
1) Osato K. et al.: Japanese Journal of Sexually
Transmitted Infections, 13, 124–130, 2002.
Japanese.
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 1030027 Japan"MEDIACE" is a trademark or registered trademark ofSEKISUI MEDICAL CO., LTD. in Japan and/or othercountries.
All other brands, product names and service names
are trademarks or registered trademarks of theirrespective companies.

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