Thrombin Time Reagent
[Product Name]
Thrombin Time Reagent
[Contents]
R1: 1 mL×5, R2: 15 mL×1;
R1: 1 mL×10, R2: 15 mL×1;
R1: 2 mL×10, R2: 30 mL×1;
R1: 4 mL×10, R2: 50 mL×1;
R1: 5 mL×10, R2: 60 mL×1;
R1: 10 mL×10, R2: 60 mL×2;
R1: 10 mL×10, R2: 120 mL×1.
[Intended Use]
It is intended for in vitro determination of Thrombin Time (TT)
of human plasma.
[Principle]
When the plasma for test is added with appropriate amount of
thrombin, the fibrinogen is converted into insoluble fibrin clot.
The time of coagulation measured on the instrument using the
optical nephelometry method is the TT of the plasma.
[Reagents Composition]
Kit consists of Reagent 1 (R1) and Reagent 2 (R2).
R1: TT Reagent: Bovine thrombin, stabilizer;
R2: TT Reconstitution Fluid: Buffer.
Note: Components in test kits of different batch numbers can’t
be interchanged.
[Storage and Stability]
The reagents store at 2-8℃. Do not freeze! The shelf life is 24
months. Reconstituted TT Reagents are stable for 7 days at 2～
8℃.
[Instruments]
Semi-automated or automated coagulation analyzers produced
by Rayto Life and Analytical Sciences Co., Ltd.
[Specimen]
1. Nine parts of freshly drawn venous blood are collected into
one part of anticoagulant and 0.109mol/L trisodium citrate.
Centrifuge at room temperature at 3000rpm for 12 minutes.
The light yellow liquid on top is the poor platelet plasma for
test.
2. Store the plasma at room temperature and test it within 2
hours.
3. If the plasma can’t be tested timely, separate with a plastic
straw and it is stable for 2 weeks at -20℃. Melt rapidly at
37℃ and gently mix immediately before testing.
Refer to CLSI H21 for further instructions on specimen
collection and storage.
[Test Procedure]
1. Preparation of Reagent
Add TT Reconstitution Fluid to TT Reagent according to the
packing volume stated on the vial label of TT Reagent, gently
shake and mix well, and allow to stand at room temperature
(15～25℃) for 15 min.
2. Test with the semi-automated coagulation analyzer.
Take 100μL plasma and incubate at 37℃ for 3 min.→
Add 50μL TT Reagent balanced at room temperature and
record the coagulation time of the plasma.
3. Test with the automated coagulation analyzer.
Conduct the test according to the operation steps of the
automated coagulation analyzer. For the doses of plasma and
reagent, refer to the above conditions.
[Expected Values]
11~17 sec.
Each laboratory should establish its own reference ranges.
[Interpretation of Test Results]
TT results can be reported in seconds. Test results are
associated with the reference ranges of the individual
laboratory.
[Limitations of the Procedure]
1. The course of coagulation includes a series of reactions from
activation of factors to fibrin formation. Therefore, test
results may be affected by therapeutic drugs (interferent),
test operations, test systems, etc., which should be
considered.
2. Reagent contamination or contamination of sample
containers, straws, etc. by blood coagulation reagent may
cause blood coagulation disorders, so strict control is
required.
[Performance Characteristics]
1. Repeatability: The coefficient of variation (CV) of the results
of repeated tests with QC plasma should not exceed 5.0%.
2. Difference between Vials: The difference between vials
should not exceed 6.0% when QC plasma is used for testing.
[Notes]
1. The product is used for in vitro diagnosis and used by
persons with major in medical laboratory or trained persons
only.
2. The test temperature should be within 37±0.5℃.
3. During the test, use plastic or siliconized test tubes, straws
and syringes only. Do not use those made of common glass.
4. The plasma fortest must not be anticoagulated by EDTA,
heparin or oxalate.
5. Hemolyzed or lipemic plasma may affect test results.
6. When the HCT of blood is out of the range of 20~55%,
adjust the dose of anticoagulant.
7. QC plasma should be tested at the same time each working
day to eliminate the interference of the instrument, reagents,
abnormal operation, etc.
[References]
1. National Guide to Clinical Laboratory Procedures (Third
Edition). Southeast University Publishing House, 2006.
2. Flanders MM, et al. Clin Chem. 2003, 49(1):169-172.
3. Wessler S, et al. Lancet. 1972, 2(7782):877-878.
[Manufacturer]
Rayto Life and Analytical Sciences Co., Ltd.
ADDR: Rayto Industrial Building, Shuangming Blvd South,
East Hi-Tech Park, Guangming New District, 518107 Shenzhen,
P.R.China
Website: www.rayto.com
[European Representative]
Shanghai International Holding Corp.GmbH(Europe)
ADDR: Eiffestrasse 80, 20537, Hamburg, Germany
Tel: 0049-40-2513175 Fax: 0049-40-255726
Symbols Explanation
V1.2e
Consult instructions for use

Temperature limit

In vitro diagnostic medical device

Authorized representative in the European

Community

Batch code

Biological risks

Manufacturer

CE Mark

Use-by date

Caution

Catalogue number

Keep top side up

R012MMAR2019V120e

V1.2e
 Prothrombin Time Reagent
[Product Name]
Prothrombin Time Reagent
[Contents]
R1: 1 mL×5, R2: 15 mL×1;
R1: 1 mL×10, R2: 15 mL×1;
R1: 2 mL×10, R2: 30 mL×1;
R1: 4 mL×10, R2: 50 mL×1;
R1: 5mL×10, R2: 60mL×1;
R1: 10mL×10, R2: 60mL×2;
R1: 10mL×10, R2: 120mL×1.
[Intended Use]
It is intended for in vitro determination of Prothrombin Time (PT)
of human plasma.
[Principle]
The plasma for test is added with tissue thromboplastin and
calcium to activate the extrinsic coagulation pathway and finally
convert fibrinogen into fibrin. The time of coagulation measured
on the instrument using the optical nephelometry method is the PT
of the plasma.
[Reagents Composition]
Kit consists of Reagent 1 (R1) and Reagent 2 (R2).
R1: PT Reagent: Rabbit thromboplastin.
R2: PT Reconstitution Fluid: Buffer.
Note: 1. Components in test kits of different batch numbers can’t
be interchanged.
2. For the ISI values of this batch of reagents, see the label
in the package label.
[Storage and Stability]
The reagents store at 2-8℃. Do not freeze! The shelf life is 24
months. Reconstituted PT Reagents are stable for 7 days at
2~8℃.
[Instruments]
Semi-automated or automated coagulation analyzers produced by
Rayto Life and Analytical Sciences Co., Ltd.
[Specimen]
1. Nine parts of freshly drawn venous blood are collected into one
part of anticoagulant and 0.109mol/L trisodium citrate.
Centrifuge at room temperature at 3000rpm for 12 minutes. The
light yellow liquid on top is the poor platelet plasma for test.
2. Store the plasma at room temperature and test it within 2 hours.
3. If the plasma can’t be tested timely, separate with a plastic straw
and it is stable for 2 weeks at -20℃. Melt rapidly at 37℃ and
gently mix immediately before testing.
Refer to CLSI H21 for further instructions on specimen collection
and preparation.
[Test Procedure]
1. Preparation of Reagent
Add PT Reconstitution Fluid to PT Reagent according to the
packing volume stated on the vial label of PT Reagent, gently
shake and mix well, and allow to stand at room temperature
(15~25℃) for 15 min.
2. Test with the semi-automated coagulation analyzer.
Take 50μL plasma and incubate at 37℃ for 3 min.→
Add 100μL PT Reagent pre-warmed to 37℃, and record the
coagulation time of the plasma.
3. Test with the automated coagulation analyzer.
Conduct the test according to the operation steps of the
automated coagulation analyzer. For the doses of plasma and
reagent, refer to the above conditions.
4. Calculation
4.1 Prothrombin Time Ratio (PTR)
PT of plasma for test (sec.)
PTR =
Mean PT of normal plasma (sec.)
4.2 International Normalized Ratio (INR)
ISI
INR  PTR
In which, ISI is International Sensitivity Index. The ISI values
of different batches of reagent vary. For the specific value, see
the package label of the respective reagent.
[Expected Values]
PT: 11~15 sec. INR: 0.8~1.5.
Each laboratory should establish its own reference ranges.
[Interpretation of Test Results]
PT results can be reported in seconds or INR. Test results are
associated with the reference ranges of the individual laboratory.
[Limitations of the Procedure]
1. The course of coagulation includes a series of reactions from
activation of factors to fibrin formation. Therefore, test results
may be affected by therapeutic drugs (interferent), test
operations, test systems, etc., which should be considered.
2. Reagent contamination or contamination of sample containers,
straws, etc. by blood coagulation reagent may cause blood
coagulation disorders, so strict control is required.
3. Only reporting PT in the form of time may cause
incomparability of results due to different ISI values.
[Performance Characteristics]
1. Repeatability: The coefficient of variation (CV) of the results of
repeated tests with QC plasma should not exceed 5.0%.
2. Difference between Vials: The difference between vials should
not exceed 6.0% when QC plasma is used for testing.
[Notes]
1. The product is for in vitro diagnosis and used by persons with
major in medical laboratory or trained persons only.
2. The test temperature should be within 37±0.5℃.
3. To measure PT, poor platelet plasma is required.
4. During the test, use plastic or siliconized test tubes, straws and
syringes only. Do not use those made of common glass.
5. The plasma for test must not be anticoagulated by EDTA,
heparin or oxalate.
6. When the HCT of blood is out of the range of 20~55%, adjust
the dose of anticoagulant.
7. QC plasma should be tested at the same time each working day
to eliminate the interference of the instrument, reagents,
abnormal operation, etc.
[References]
1. National Guide to Clinical Laboratory Procedures (Third
Edition), Southeast University Publishing House, 2006.
2. ICSH/ICTH. J Clin Pathol. 1985, 38(2):133-134.
3. Quick AJ. Science. 1940, 92(2379):113-114.
V1.2e
[Manufacturer]
Rayto Life and Analytical Sciences Co., Ltd.
ADDR: Rayto Industrial Building, Shuangming Blvd South, East
Hi-Tech Park, Guangming New District, 518107 Shenzhen,
P.R.China
Website: www.rayto.com
[European Representative]
Shanghai International Holding Corp.GmbH(Europe)
ADDR: Eiffestrasse 80, 20537, Hamburg, Germany
Tel: 0049-40-2513175 Fax: 0049-40-255726
Symbols Explanation

Consult instructions for use

Temperature limit

In vitro diagnostic medical device

Authorized representative in the European

Community

Batch code

Biological risks

Manufacturer

CE Mark

Use-by date

Caution

Catalogue number

Keep top side up

R010MMAR2019V120e

V1.2e
 Dilution Plasma Buffer FIB Concentration
Fibrinogen Reagent Ratio (µL) (µL) (g/L)
1:5 50 200 Assigned value × 2
[Product Name] Fibrinogen Reagent 1:10 50 450 Assigned value × 1
[Contents] 1:15 50 700 Assigned value × 2/3
R1: 1 mL×5, R2: 50 mL×1, R3: 1mL×1; 1:20 50 950 Assigned value × 1/2
R1: 1 mL×5, R2: 100 mL×1, R3: 1mL×1; 1:30 50 1,450 Assigned value × 1/3
R1: 2 mL×5, R2: 100 mL×1, R3: 1mL×1;
R1: 4 mL×5, R2: 100 mL×1, R3: 1mL×1;
R1: 8 mL×5, R2: 100 mL×2, R3: 1mL×1. 3. Assay with the semi-automated coagulation analyzer.
[Intended Use] Dilute the plasma for test with Imidazole Buffer into 1:10 dilution,
It is intended for in vitro determination of Fibrinogen (FIB) i.e. one part of plasma and nine parts of buffer.
concentration in human plasma. Take 100µL diluted plasma and incubate at 37℃ for 3 min.→
[Principle] Add 50µL FIB Reagent balanced at room temperature and record
Based on the principle of the Clauss clotting Method, in the presence the coagulation time of the plasma.
of excessive thrombin, the coagulation time of the diluted plasma for * Note: If the plasma is diluted at the ratio of 1:10 and the
test shows inversely proportional to its fibrinogen concentration in coagulation time is out of the range of the standard curve, in
log-log. The time of coagulation is measured on the instrument using order to reduce the error, dilute the plasma at the ratio of 1:5
the optical nephelometry method, and the fibrinogen concentration is or 1:20 before testing, multiply the result by 0.5 or 2, and
obtained from the standard curve. calculate the actual concentration of FIB.
[Reagents Composition] 4. Assay with the automated coagulation analyzer.
Kit consists of R1, R2, and R3. Conduct the test according to the operation steps of the automated
R1: FIB Reagent: Bovine thrombin, stabilizer; coagulation analyzer. For the doses of plasma and reagent, refer to
R2: Imidazole Buffer: imidazole; the above conditions.
R3: FIB Reference Plasma: Fibrinogen, stabilizer. 5. Calculation
[Storage and Stability] According to the coagulation time, the FIB concentration can be
The reagents store at 2-8℃. Do not freeze! The shelf life is 24 obtained from the standard curve.
months. After opened vials reconstituted and stored at 2～8℃, FIB [Expected Values]
Reagent is stable for 7 days, FIB Reference Plasma is stable for 8 2 ~ 4 g/L.
hours. Each laboratory should establish its own reference ranges.
[Instruments] [Interpretation of Test Results]
Semi-automated or automated coagulation analyzers produced by FIB concentrations are reported in g/L. Test results are associated
Rayto Life and Analytical Sciences Co., Ltd. with the reference ranges of the individual laboratory.
[Specimen] [Limitations of the Procedure]
1. Nine parts of freshly drawn venous blood are collected into one 1. The course of coagulation includes a series of reactions from
part of anticoagulant and 0.109mol/L trisodium citrate. Centrifuge activation of factors to fibrin formation. Therefore, test results
at room temperature at 3000rpm for 12 minutes. The light yellow may be affected by therapeutic drugs (interferent), test operations,
liquid on top is the poor platelet plasma for test. test systems, etc., which should be considered.
2. Store the plasma at room temperature and test it within 2 hours. 2. Reagent contamination or contamination of sample containers,
3. If the plasma can’t be tested timely, separate with a plastic straw straws, etc. by blood coagulation reagent may cause blood
and it is stable for 2 weeks at -20℃. Melt rapidly at 37℃ and coagulation disorders, so strict control is required.
gently mix immediately before testing. 3. Too high a FIB degradation product (FDP) concentration may
Refer to CLSI H21 for further instructions on specimen collection prolong the coagulation time and cause a false low level of FIB.
and preparation. [Performance Characteristics]
[Test Procedure]
1. Repeatability: The coefficient of variation (CV) of the results of
1. Preparation of Reagent
repeated tests with QC plasma should not exceed 5.0% for normal
Add distilled water to FIB Reagent according to the packing
volume stated on the vial label of FIB Reagent, gently shake and values or 8.0% for abnormal values
mix well, and allow to stand at room temperature (15～25℃) for 2. Difference between Vials: The difference between vials should not
15 min. Add 1.0mL distilled water to each vial of FIB Reference exceed 6.0% when QC plasma is used for testing.
Plasma, gently shake and mix well, and allow to stand at room 3. Linearity: Within the FIB test range, The linear correlation
temperature for 15 min. coefficient r should be > 0.98.
2. Preparation of Standard Curve [Notes]
According to the table below, use Imidazole Buffer to dilute 1. The product is for in vitro diagnosis and used by persons with
Reference Plasma into solutions at different dilution ratios and major in medical laboratory or trained persons only.
measure the coagulation time of the diluted plasmas. 2. During the test, use plastic or siliconized test tubes, straws and
Take the dilution ratio of 1:10 as the assigned value of FIB, the
syringes only. Do not use those made of common glass.
theoretical concentration as the y axis, and the corresponding
3. The plasma for test must not be anticoagulated by EDTA, heparin
coagulation time as the x axis to prepare the standard curve on the
log-log coordinate. or oxalate.
4. Hemolyzed or lipemic plasma may affect test results.
5. When the batch numbers of reagents or the environmental
conditions are changed, prepare new standard curve.
[References]
V1.2e
1. National Guide to Clinical Laboratory Procedures (Third Edition),
Southeast University Publishing House, 2006.
2. Grannis GF. Clin Chem. 1970, 16(6):486–494.
[Manufacturer]
Rayto Life and Analytical Sciences Co., Ltd.
ADDR: Rayto Industrial Building, Shuangming Blvd South, East
Hi-Tech Park, Guangming New District, 518107 Shenzhen,
P.R.China
Website: www.rayto.com
[European Representative]
Shanghai International Holding Corp.GmbH(Europe)
ADDR: Eiffestrasse 80, 20537, Hamburg, Germany
Tel: 0049-40-2513175 Fax: 0049-40-255726

Symbols Explanation

Consult instructions for use

Temperature limit

In vitro diagnostic medical device

Authorized representative in the European

Community

Batch code

Biological risks

Manufacturer

CE Mark

Use-by date

Caution

Catalogue number

Keep top side up

R013MMAR2019V120e

V1.2e
 Rayto Life and Analytical Sciences Co., Ltd.

Reagent 1 (R1) is composed of PBS buffer and surfactant.

Fibrin and Fibrinogen Degradation Reagent 2 (R2) is composed of PBS buffer, surfactant and slatex particles
coated with monoclonal anti-human FDP antibodies (mouse).
Calibrator (optional): FDP and preservative.
Products Assay Reagent Kit QC (optional): FDP and preservative.
The calibrator is from human-derived samples. The FDP concentration is on
(Latex-Enhanced the calibrator label. The definite value of FDP calibrator can be traced to the
SUNBIO calibrator.
[Storage and stability]
Immunoturbidimetric) Store at 2-8℃ in the dark. Do not freeze the reagent! The storage life of
reagents is 12 months and the storage life of the calibrator and QC is 18
[Product Name]
months. Opened reagents are stable for 12 days and the opened calibrator
Fibrin and Fibrinogen Degradation Products Assay Reagent Kit
and QC are stable for 24 hours when stored at 2˚C~8˚C.
(Latex-Enhanced Immunoturbidimetric)
[Instrument]
[Package Sizes]
This reagent is mainly applicable to the following types of semi-automated
No. Specifications
or automated biochemical analyzers and coagulation analyzers. It is
R1:3mL×6,R2:3mL×2; Calibrator(optional):1×1mL;
1 suggested that you verify test results according to the actual situation of the
Control(optional):1×1mL.
laboratory when using this reagent. Relative parameters are available for
R1:3mL×9,R2:3mL×3; Calibrator(optional):1×1mL;
2 professional user on request. The list of instruments is as follows:
Control(optional):1×1mL
Chemray 120, Chemray 160, Chemray 180, Chemray 200, Chemray 240,
R1:4mL×9,R2:4mL×3; Calibrator(optional):1×1mL;
3 Chemray 260, Chemray 280, Chemray 300, Chemray 310, Chemray 320,
Control(optional):1×1mL
Chemray 360, Chemray 380, Chemray 400, Chemray 420, Chemray 800,
R1:5mL×9,R2:5mL×3; Calibrator(optional):1×1mL;
4 Chemray 820, Chemray 850, Chemray 880, RT-1904C, RT-9000, RT-9100,
Control(optional):1×1mL
RT-9200, RT-9300, RT-9500, RT-9600, RT-9800, RT-9900, RAC-020,
R1:30mL×1,R2:10mL×1; Calibrator(optional):1×1mL;
5 RAC-030, RAC-050, RAC-060, RAC-100, RAC-120, RAC-130,
Control(optional):1×1mL
RAC-1800, RAC-1810, RAC-1830, RAC-1860, RAC-1890, RT-2201C,
R1:30mL×2,R2:10mL×2; Calibrator(optional):1×1mL; RT-2202, RT-2202C, RT-2204C, RAC-2800, RAC-2820.
6
Control(optional):1×1mL [Specimen]
R1:3mL×6, R2: 3mL×6; Calibrator(optional):1×1mL; Venous blood is collected in the blood collection tube containing
7
Control(optional):1×1mL 0.109mol/L sodium citrate of 1/10 volume. Centrifuge the blood, and get the
R1:20mL×1,R2:20mL×1; Calibrator(optional):1×1mL; upper plasma. Hemolyzed samples should be avoided. Conduct the test on
8
Control(optional):1×1mL the date of collection. If the sample collected cannot be tested on the same
R1:9mL×3,R2:3mL×3; Calibrator(optional):1×1mL; day, store it at -20˚C (it is suggested to use it within one month). Before
9
Control(optional):1×1mL using, soak it in water at 37˚C for rapid re-dissolution. Never freeze and
R1:9mL×6, R2: 3mL×6; Calibrator(optional):1×1mL; melt it again.
10
Control(optional):1×1mL [Test Procedure]
[Intended Use] (1) Test Conditions:
In vitro test for the quantitative determination of fibrin (fibrinogen) Reaction
37˚C Sample Size 10μL
Temperature
degradation product concentration in plasma.
Main
In primary hyperfibrinolysis, the fibrin (fibrinogen) degradation product 570nm Volume of R1 150μL
Wavelength
(FDP) concentration significantly increases. In secondary hyperfibrinolysis Assay Method Endpoint Method Volume of R2 50μL
caused by hypercoagulable state, disseminated intravascular coagulation, Delay Time 10s~30s Test Time 60s~120s
pulmonary embolism, rejection after organ transplantation, Calibration
Multi-point Nonlinear
pregnancy-induced hypertension, malignant tumor, heart, hepatic and renal Mode
diseases, phlebothrombosis, thrombolytic therapy, etc., the FDP (2) Calibration Procedure:
concentration increases. Use a calibrator supporting the reagent, conduct multi-point nonlinear
[Principle] calibration, dilute the calibrator with physiological saline, and establish a
This Reagent uses the Latex-enhanced Immunoturbidimetric Assay to test working curve with physiological saline as the zero point.
the fibrin (fibrinogen) degradation product concentration in human plasma. Tube No. 1 2 3 4 5 6
Latex particles of uniform size are coated with monoclonal antibodies to the Stoste :
Physiological
fibrin (fibrinogen) degradation product. The antigen/antibody complexes Physiological 1: 4 2: 3 3: 2 4: 1 Stoste
Saline
Saline
produced by the addition of samples containing FDP lead to an increase in
the turbidity of the test reactants. The change of absorbance is dependent on Concentration 0.0 X/5 2X/5 3X/5 4X/5 X
the concentration of fibrin (fibrinogen) degradation product in the sample. Calibration frequency depends on the frequency of use. If the lot number of
The precipitate is determined turbidimetrically. The unit of measurement the reagent changes, the instrument is repaired or maintained or the critical
results is mg/L. component is replaced, the QC results shift or exceed the specified range,
[Reagentscomposition] etc., recalibration is necessary. Until the QC tests pass again, procedure
The reagent is composed of R1, R2, calibrator and QC. The main returns to normal.
components are as follows: (3) QC Procedure:
V1.2e
 Rayto Life and Analytical Sciences Co., Ltd.

Test the QC supporting the reagent. Only when the test results are in the QC 5. Do not exchange or mix the components of reagents of different lot
range can the samples be tested. In normal cases, each time a patient’s numbers. Do not mix reagents newly opened with those used, otherwise the
sample is to be tested, the QC selected should be tested at least once. If the stability of reagents may decrease.
lot number of the reagent changes, the instrument is repaired or maintained 6. The reagents contain chemicals. Do not eat them mistakenly or expose
or the critical component is replaced, the determination results of the QC your skin or mucous membrane to them. In case of eye, mouth or skin
shift or exceed the specified range, etc., the QC selected should be tested at contact, flush with plenty of clear water, go to the doctor if necessary.
least once. 7. The liquid waste from the plasma test presents potential biohazard risk.
The handling procedure to be followed when the determination results of the Personal protections are necessary and dispose the liquid waste in
QC shift or exceed the specified range:1) retest the QC selected; 2) if the accordance with the local regulations.
determination results are unchanged, consider replacing with a new bottle of 8. Kit test results are only as a reference for clinical diagnosis.
QC for redetermination; 3) if the determination results are still unchanged, [References]
consider recalibration before determination of the QC; 4) if the 1. Moresco RN, Halla-Junior R, Vargas LCR, et al. Association between
determination results are still unchanged, consider replacing with a new plasma levels of D-dimer and fibrinogen/fibrin degradation products (FDP)
bottle (or lot) of reagent for redetermination; 5) if the determination results for exclusion of thromboembolic disorders. J Thromb Thrombolysis, 2006,
are still unchanged, consider contacting our Technical Service Department. 21:199-202.
(4) Calculation: 2. Rafael NoalMoresco, Luis Claudio Rosa Vargas, Lucia Silla. Estimation
of the levels of D-dimer by use for an alternative method based in the
reaction time of fibrinogen/fibrin degradation products assay. Journal of
Thrombolysis, 2007, 24(1):73-76.
3. Ye Yingwu and Wang Yusan, National Guide to Clinical Laboratory
Procedures (Third Edition), Southeast University Publishing House, Nov.
2006.
[Manufacturer]
[Reference Values]
Enterprise: Rayto Life and Analytical Sciences Co., Ltd.
0 mg/L~5mg/L (n=210, 95% confidence limit).
Address: Rayto Industrial Building, Shuangming Blvd South, East Hi-Tech
Due to the normal and reasonable difference between regions and
Park, Guangming New District, 518107 Shenzhen, P.R.China
individuals as well as the different test methods adopted, the values of FDP
Tel: +086 755-26670255 Fax: +086 755-26670256
concentration may vary. It is suggested that each laboratory establish its own
Website: www.rayto.com
reference values for the population that it serves.
[European Representative]
[Interpretation of Test Results]
Shanghai International Holding Corp.GmbH (Europe)
A professional should audit the test results. Affected by the age, sex, diet
ADDR: Eiffestrasse 80, 20537, Hamburg, Germany
and region, the results in the reference interval are usually regarded as
Tel: 0049-40-2513175 Fax: 0049-40-255726
normal; if the results exceed the range, redetermination should be conducted
[Symbols Explanation]
for confirmation. The test results reflect the status at the time only, the
results should be assessed in conjunction with the clinical and other test Consult instructions for use
indicators. If the test results do not agree or even contradict with the clinical
Temperature limit
situation, analysis should be conducted to find the causes.
[Limitations of the Procedure] In vitro diagnostic medical device
1. The linear range of the reagent is 2.5mg/L～80mg/L(37˚C). For a sample
exceeding the linear range, dilute it with physiological saline before the test. Authorized representative in the European Community
2. This assay is affected by many pretest factors, including sample collection
Batch code
and storage, proficiency of technicians, interfering substances, etc. These
factors must be strictly controlled. Biological risks
[Performance Characteristics]
1. Linear Range: 2.5mg/L~80mg/L (37˚C). The correlation coefficient (r) Manufacturer
should be ≥ 0.990.
CE Mark
2. Repeatability: CV ≤ 10%.
3. Lot Tolerance: ≤ 15%.
Use-by date
4. Accuracy: Relative Deviation ≤ ±15%.
[Notes] Caution
1. The reagent is only for in vitro diagnosis and operated by medical
professionals or trained workers. Catalogue number
2. The volume of the reagent and the sample can be changed proportionally
Keep top side up
according to the different instrument requirements. Specific setting
parameters are available from the manufacturer.
3. Use calibrators supporting this reagent or those recommended to calibrate
the instrument.
4. For a reagent of a different lot number, please use the calibrator to
conduct recalibration before testing. R076MMAR2019V120e

V1.2e
 Rayto Life and Analytical Sciences Co., Ltd.

The calibrator is from human-derived samples. The D-Dimer concentration

D-Dimer Assay Reagent Kit is on the calibrator label. The definite value of D-Dimer calibrator can be
traced to the Roche D-DIMMER calibrator.
[Storage and Stability]
(Latex-Enhanced Store at 2-8℃ in the dark. Do not freeze the reagents! The storage life of
reagents is 12 months and the storage life of the calibrator and QC is 18
Immunoturbidimetric) months. Opened reagents are stable for 12 days and the opened calibrator
and QC are stable for 24 hours when stored at 2˚C~8˚C.
[Product Name] [Instrument]
D-Dimer Assay Reagent Kit (Latex-Enhanced Immunoturbidimetric) This reagent is mainly applicable to the following types of semi-automated
[Package Sizes] or automated biochemical analyzers and coagulation analyzers. It is
No. Specifications suggested that you verify test results according to the actual situation of the
laboratory when using this reagent. Relative parameters are available for
R1:3mL×6,R2:3mL×2; Calibrator(optional):1×1mL;
1 professional user on request. The list of instruments is as follows:
Control(optional):1×1mL
Chemray 120, Chemray 160, Chemray 180, Chemray 200, Chemray 240,
R1:3mL×9,R2:3mL×3;Calibrator(optional):1×1mL;
2 Chemray 260, Chemray 280, Chemray300, Chemray 310, Chemray 320,
Control(optional):1×1mL
Chemray 360,Chemray 380, Chemray 400, Chemray 420, Chemray 800,
R1:4mL×9,R2:4mL×3;Calibrator(optional):1×1mL;
3 Chemray 820, Chemray 850, Chemray 880, RT-1904C, RT-9000, RT-9100,
Control(optional):1×1mL
RT-9200, RT-9300, RT-9500, RT-9600, RT-9800, RT-9900, RAC-2800,
R1:5mL×9,R2:5mL×3;Calibrator(optional):1×1mL; RAC-2820.
4
Control(optional):1×1mL [Samples]
R1:30mL×1,R2:10mL×1;Calibrator(optional):1×1mL; Venous blood is collected in the blood collection tube containing
5
Control(optional):1×1mL 0.109mol/L sodium citrate of 1/10 volume. Centrifuge the blood, and get the
R1:30mL×2,R2:10mL×2;Calibrator(optional):1×1mL; upper plasma. Hemolyzed samples should be avoided. Conduct the test on
6
Control(optional):1×1mL the date of collection. If the sample collected cannot be tested on the same
R1:3mL×6, R2: 3mL×6;Calibrator(optional):1×1mL; day, store it at -20˚C (it is suggested to use it within one month). Before
7
Control(optional):1×1mL using, soak it in water at 37˚C for rapid re-dissolution. Never freeze and
R1:20mL×1,R2:20mL×1;Calibrator(optional):1×1mL; melt it again.
8
Control(optional):1×1mL [Procedure]
R1:9mL×3, R2: 3mL×3;Calibrator(optional):1×1mL; (1) Test Conditions:
9
Control(optional):1×1mL Temperature 37˚C Sample Size 12.0μL
R1:9mL×6,R2:3mL×6;Calibrator(optional):1×1mL; Main Wavelength 570nm-800nm Volume of R1 150μL
10
Control(optional):1×1mL Endpoint
Assay Method Volume of R2 50μL
[Intended Use] Method
In vitro test for the quantitative determination of D-Dimer concentration in Calibration Multi-point
Delay Time 10s～40s
plasma. Mode Nonlinear
D-Dimer is a characteristic product of cross-linked fibrin degradation. It Reaction Time 60s～120s
increases in deep venous thrombosis, pulmonary embolism, disseminated (2) Calibration Procedure:
intravascular coagulation, serious hepatitis, pulmonary embolism, etc. and Use a calibrator supporting the reagent, conduct multi-point nonlinear
can be taken as an effective obvervational index of thrombolytic therapy. calibration, dilute the calibrator with physiological saline, and establish a
D-Dimer is positive or increases in secondary fibrinolysis, and is negative or working curve with physiological saline as the zero point.
does not increase in primary fibrinolysis, so it is the important index for
distinguishing the two clinically. Tube No. 1 2 3 4 5 6
[Principle]
Latex particles of uniform size are coated with monoclonal antibodies to the Stoste:
Physiological
Physiological 1: 4 2: 3 3: 2 4: 1 Stoste
D-Dimer epitope. The antigen/antibody complexes produced by the addition Saline
Saline
of samples containing D-Dimer lead to an increase in the turbidity of the test
reactants. The change of absorbance with time is dependent on the
Concentration 0.0 X/5 2X/5 3X/5 4X/5 X
concentration of D-Dimer epitopes in the sample. The precipitate is
determined turbidimetrically. Comparing with the standard plasma, the D-D Calibration frequency depends on the frequency of use. If the lot number of
concentration in the plasma sample can be obtained. the reagent changes, the instrument is repaired or maintained or the critical
[Reagent Composition] component is replaced, the QC results shift or exceed the specified range,
The reagent is composed of R1, R2, calibrator and QC. The main etc., recalibration is necessary. Until the QC tests pass again, procedure
components are as follows: returns to normal.
Reagent 1 (R1) is composed of PBS buffer and surfactant. (3) QC Procedure:
Reagent 2 (R2) is composed of PBS buffer, surfactant and latex particles Use the QC supporting the reagent, only when the test results are in the QC
coated with monoclonal anti-human D-Dimer antibodies(mouse). range can the samples be tested. In normal cases, each time a patient’s
Calibrator (optional): D-Dimer and preservative. sample is to be tested, the QC selected should be tested at least once. If the
QC (optional): D-Dimer and preservative. lot number of the reagent changes, the instrument is repaired or maintained
V1.2e
 Rayto Life and Analytical Sciences Co., Ltd.

or the critical component is replaced, the determination results of the QC contact, flush with plenty of clear water, go to the doctor if necessary.
shift or exceed the specified range, etc., the QC selected should be tested at 7. The liquid waste from the plasma test presents potential biohazard risk.
least once. Personal protections are necessary and dispose the liquid waste in
The handling procedure to be followed when the determination results of the accordance with the local regulations.
QC shift or exceed the specified range: 1) retest the QC selected; 2) if the 8. Kit test results are only as a reference for clinical diagnosis.
determination results are unchanged, consider replacing with a new bottle of [References]
QC for redetermination; 3) if the determination results are still unchanged, 1. Reber G. & de Moerloose P. Standardization of D-dimer testing. Quality
consider recalibration before determination of the QC; 4) if the in Laboratory Hemostasis and Thrembosis. 2009, 99-109.
determination results are still unchanged, consider replacing with a new 2. Di Nisio M, Squizzato A, Rutjes AW, et al. Diagnostic accuracy of
bottle (or lot) of reagent for redetermination; 5) if the determination results D-Dimer test for exclusion of venous thromboembolism: a systematioc
are still unchanged, consider contacting our Technical Service Department. review. J ThrombHaemost, 2007: 296-304.
(5) Calculation: 3. Ye Yingwu and Wang Yusan, National Guide to Clinical Laboratory
Procedures (Third Edition), Southeast University Publishing House, Nov.
2006.
[Manufacturer]
Enterprise: Rayto Life and Analytical Sciences Co., Ltd.
Address: Rayto Industrial Building, Shuangming Blvd South, East Hi-Tech
[Reference Values] Park, Guangming New District, 518107 Shenzhen, P.R.China
0mg/L～0.50mg/L(n=209, 95% confidence limit). Tel: +086 755-26670255 Fax: +086 755-26670256
Due to the normal and reasonable difference between regions and Website: www.rayto.com
individuals as well as the different test methods adopted, the values of [European Representative]
D-Dimer concentration may vary. It is suggested that each laboratory Shanghai International Holding Corp.GmbH (Europe)
establish its own reference ranges for the population that it serves. ADDR: Eiffestrasse 80, 20537, Hamburg, Germany
[Interpretation of Test Results] Tel: 0049-40-2513175 Fax: 0049-40-255726
A professional should audit the test results. Affected by the age, sex, diet [Symbols Explanation]
and region, the results in the reference interval are usually regarded as Consult instructions for use
normal; if the results exceed the range, redetermination should be conducted
for confirmation. The test results reflect the status at the time only, the Temperature limit
results should be assessed in conjunction with the clinical and other test
In vitro diagnostic medical device
indicators. If the test results do not agree or even contradict with the clinical
situation, analysis should be conducted to find the causes. Authorized representative in the European Community
[Limitation of the Procedure]
1. The linear range of the reagent is 0.20mg/L~20.00mg/L (37˚C). For a Batch code
sample exceeding the linear range, dilute it with physiological saline before
Biological risks
the test.
2. This assay is affected by many pretest factors, including sample collection Manufacturer
and storage, proficiency of technicians, interfering substances, etc. These
factors must be strictly controlled. CE Mark
[Performance Characteristics]
Use-by date
1. Linear Range: 0.20mg/L~20.00mg/L (37˚C). The correlation coefficient
(r) should be ≥ 0.990.
Caution
2. Repeatability: CV ≤ 10%.
3. Lot Tolerance: ≤ 15%. Catalogue number
4. Accuracy: Relative Deviation ≤ ±15%.
[Notes] Keep top side up

1. The reagent is only for in vitro diagnosis and operated by medical

professionals or trained workers.
2. The dosage of reagents and samples can be changed proportionally
according to the different instrument requirements. Specific setting
parameters are available from the manufacturer.
3. Use calibrators supporting this reagent or those recommended to calibrate R075MMAR2019V120e
the instrument.
4. For a reagent of a different lot number, please use the calibrator to
conduct recalibration before testing.
5. Do not exchange or mix the components of reagents of different lot
numbers. Do not mix reagents newly opened with those used, otherwise the
stability of reagents may decrease.
6. The reagents contain chemicals. Do not eat them mistakenly or expose
your skin or mucous membrane to them. In case of eye, mouth or skin

V1.2e
 Rayto Life and Analytical Sciences Co., Ltd.
Opened reagents are stable for 7 days and the opened calibrator is stable for
Antithrombin Ⅲ Assay Reagent Kit 8 hours when stored at 2˚C~8˚C.
[Instrument]
This reagent is mainly applicable to the following types of semi-automated
（Chromogenic Substrate Method) or automated biochemical analyzers and coagulation analyzers. It is
suggested that you verify test results according to the actual situation of the
[Product Name]
laboratory when using this reagent. Relative parameters are available for
Antithrombin Ⅲ Assay Reagent Kit（Chromogenic Substrate Method） professional user on request. The list of instruments is as follows:
[Package Sizes] Chemray 120, Chemray 160, Chemray 180, Chemray 200, Chemray 240,
No. Specifications Chemray 260, Chemray 280, Chemray 300, Chemray 310, Chemray 320,
R1:3mL×5,R2:3mL×5; R1 Reconstitution Chemray 360, Chemray 380, Chemray 400, Chemray 420, Chemray 800,
1
Fluid 16mL; Calibrator (optional):1×1mL Chemray 820, Chemray 850, Chemray 880, RT-1904C, RT-9000, RT-9100,
R1: 5mL×5, R2:5mL×5; R1 Reconstitution RT-9200, RT-9300, RT-9500, RT-9600, RT-9800, RT-9900, RAC-2800,
2
Fluid 26mL; Calibrator (optional): 1×1mL RAC-2820.
R1:6mL×2,R2:4mL×2; R1 Reconstitution [Samples]
3
Fluid 16mL; Calibrator (optional): 1×1mL Venous blood is collected in the blood collection tube containing
R1:6mL×5,R2:4mL×5; R1 Reconstitution 0.109mol/L sodium citrate of 1/10 volume. Centrifuge at 3000rpm for 10
4
Fluid 31mL; Calibrator (optional): 1×1mL minutes. Collect the plasma on top. Hemolyzed samples should be avoided.
R1:10mL×1,R2:10mL×1; R1 Reconstitution Conduct the test on the date of collection. If the sample collected cannot be
5
Fluid 16mL; Calibrator (optional): 1×1mL tested on the same day, store it at -20˚C. Before using, rapidly unfreeze it at
R1: 15mL×2,R2:15mL×2; R1 Reconstitution 37˚C. Use it timely after unfreezing. Never freeze and melt it again.
6
Fluid 31mL; Calibrator (optional): 1×1mL [Procedure]
R1:10mL×2,R2:10mL×2; R1 Reconstitution (1) Reagent Preparation:
7
Fluid 21mL; Calibrator (optional): 1×1mL Redissolve AT-Ⅲ R1 with the AT-Ⅲ R1 reconstitution fluid with the
[Intended Use] indicating volume, and gently rotate and blend.
In vitro test for the quantitative determination of antithrombin Ⅲ activity Redissolve AT-Ⅲ R2 with the distilled water with the indicating volume,
in plasma. and gently rotate and blend.
Antithrombin Ⅲ (AT-Ⅲ) is mainly used to diagnose thrombotic diseases (2) Test Conditions:
caused by AT-Ⅲ deficiency. AT-Ⅲ increase can be seen in hemophilia A Reaction
37˚C Sample Size 3μL
and B, leukemia, aplastic anemia and the therapeutic process with oral Temperature
anticoagulants. AT-Ⅲ decrease can be seen in genetic or acquired AT-Ⅲ Main
405nm Volume of R1 90μL
deficiency. Genetic AT-Ⅲ deficiency is an autosomal dominant genetic Wavelength
disease, where patients suffer from repeated phlebothrombosis after Endpoint
Assay Method Volume of R2 90μL
operation, wound, infection, pregnancy or delivery. Acquired AT- Ⅲ Method
deficiency can be seen in AT synthesis depression, increase of AT loss and Delay Time 10s~30s Test Time 20s~60s
higher AT consumption. Calibration
Multi-point Nonlinear
[Principle] Mode
This test works according to the Antithrombin Heparin Cofactor assay (3) Calibration Procedure:
principle. Heparin and a predefined amount of thrombin are added to the Use a calibrator supporting the reagent, conduct multi-point nonlinear
samplein excess. All free antithrombin present binds to thrombin to form calibration, dilute the calibrator with physiological saline, and establish a
aninactive complex. Non-inhibited thrombin liberates p-nitroaniline from working curve with physiological saline as the zero point.
the chromogenic substrate. The remaining amount of thrombin is inversely Tube No. 1 2 3 4 5 6
proportional to the antithrombin Ⅲ content of thesample and therefore the
Stoste :
increase in absorbance at a wavelength of405 nm can be used to calculate Physiological
Physiological 1: 4 2: 3 3: 2 4: 1 Stoste
the antithrombin Ⅲ activity. Saline
Saline
[Reagent Composition]
The reagent is composed of R1, R2, R1 reconstitution fluid and calibrator. Concentration 0.0 X/5 2X/5 3X/5 4X/5 X
The main components are as follows: Calibration frequency depends on the frequency of use. If the lot number of
Reagent 1 (R1) is composed of buffer and thrombin. the reagent changes, the instrument is repaired or maintained or the critical
Reagent 2 (R2) is composed of chromogenic substrate. component is replaced, the QC results shift or exceed the specified range,
R1 reconstitution fluid: Trisand preservative. etc., recalibration is necessary. Until the QC tests pass again, procedure
Calibrator (optional): AT-Ⅲ and preservative. returns to normal.
The calibrator is from human-derived samples. Theantithrombin Ⅲ (4) QC Procedure:
concentration is on the calibrator label. The definite value of antithrombin It is recommended to use SIEMENS QC blood plasmaor other conforming
Ⅲ calibrator can be traced to the SIEMENS calibrator. QC of the same methodology as the determination QC. Only when the test
[Storage and Stability] results are in the QC range can the samples be tested. In normal cases, each
Store at 2-8℃ in the dark. Do not freeze the reagents! The storage life of time a patient’s sample is to be tested, the QC selected should be tested at
reagents is 12 months and the storage life of the calibrator is 18 months. least once. If the lot number of the reagent changes, the instrument is
repaired or maintained or the critical component is replaced, the

V1.2e
 Rayto Life and Analytical Sciences Co., Ltd.
determination results of the QC shift or exceed the specified range, etc., the 7. The liquid waste from the plasma test presents potential biohazard risk.
QC selected should be tested at least once. Personal protections are necessary and dispose the liquid waste in
accordance with the local regulations.
The handling procedure to be followed when the determination results of the
8. Kit test results are only as a reference for clinical diagnosis.
QC shift or exceed the specified range:1) retest the QC selected; 2) if the
[References]
determination results are unchanged, consider replacing with a new bottle of
1. Michael F, Scully Ph.D, The use of an automated analyzer in the
QC for redetermination; 3) if the determination results are still unchanged,
evaluation of antithrombin Ⅲ and heparin. Thrombosis and Hemostasis,
consider recalibration before determination of the QC; 4) if the
1983, 9(46):303-314.
determination results are still unchanged, consider replacing with a new
2. Earle W. Holmes, Jaweed Fareed, et al. Automation of plasma
bottle (or lot) of reagent for redetermination; 5) if the determination results
antithrombin Ⅲ assays. Clin Chem. 1981, 27(6):816-818.
are still unchanged, consider contacting our Technical Service Department.
3. WinfridePrellwitz, Karl-Friedrich Schmitt, et al. Two automated methods
(5) Calculation:
for plasma antithrombin Ⅲ compared, and the clinical significance of the
results. Clin Chem. 1982, 28(11):2249-2254.
[Manufacturer]
Enterprise: Rayto Life and Analytical Sciences Co., Ltd.
Address: Rayto Industrial Building, Shuangming Blvd South, East Hi-Tech
Park, Guangming New District, 518107 Shenzhen, P.R.China
[Reference Values] Tel: +086 755-26670255 Fax: +086 755-26670256
80%~120% (n=208, 95% confidence limit). Website: www.rayto.com
Due to the normal and reasonable difference between regions and [European Representative]
individuals as well as the different test methods adopted, the values of AT-Ⅲ Shanghai International Holding Corp.GmbH (Europe)
activity may vary. It is suggested that each laboratory establish its own ADDR: Eiffestrasse 80, 20537, Hamburg, Germany
reference ranges for the population that it serves. Tel: 0049-40-2513175 Fax: 0049-40-255726
[Interpretation of Test Results] [Symbols Explanation]
A professional should audit the test results. Affected by the age, sex, diet
Consult instructions for use
and region, the results in the reference interval are usually regarded as
normal; if the results exceed the range, redetermination should be conducted
Temperature limit
for confirmation. The test results reflect the status at the time only,the results
should be assessed in conjunction with the clinical and other test indicators. In vitro diagnostic medical device
If the test results do not agree or even contradict with the clinical situation,
analysis should be conducted to find the causes. Authorized representative in the European Community
[Limitations of the Procedure]
Batch code
1. The linear range of the reagent is 0%~140% (37˚C). For a sample
exceeding the linear range, dilute it with physiological saline before the test. Biological risks
2. This assay is affected by many pretest factors, including sample collection
and storage, proficiency of technicians, interfering substances, etc. These Manufacturer
factors must be strictly controlled.
[Performance Characteristics] CE Mark
1. Linear Range: 10%~140% (37˚C). The correlation coefficient (r) should
Use-by date
be ≥ 0.990.
2. Repeatability: CV ≤ 10%. Caution
3. Lot Tolerance: ≤ 15%.
4. Accuracy: Relative Deviation ≤ ±15%. Catalogue number
[Notes]
Keep top side up
1. The reagent is only for in vitro diagnosis and operated by medical
professionals or trained workers.
2. The dosage of reagents and samples can be changed proportionally
according to the different instrument requirements. Specific setting
parameters are available from the manufacturer.
3. Use calibrators supporting this reagent or those recommended to calibrate
R077MMAR2019V120e
the instrument.
4. For a reagent of a different lot number, please use the calibrator to
conduct recalibration before testing.
5. Do not exchange or mix the components of reagents of different lot
numbers. Do not mix reagents newly opened with those used, otherwise the
stability of reagents may decrease.
6. The reagents contain chemicals. Do not eat them mistakenly or expose
your skin or mucous membrane to them. In case of eye, mouth or skin
contact, flush with plenty of clear water, go to the doctor if necessary.

V1.2e
 Activated Partial Thromboplastin Time Reagent
[Product Name]
Activated Partial Thromboplastin Time Reagent
[Contents]
R1: 1 mL×5, R2: 15 mL×1;
R1: 1mL×10, R2: 30 mL×1;
R1: 2 mL×10, R2: 30 mL×1;
R1: 4 mL×10, R2: 50 mL×1;
R1: 5mL×10, R2: 75mL×1;
R1: 10mL×10, R2: 75mL×2;
R1: 10mL×10, R2: 150mL×1.
[Intended Use]
It is intended for in vitro determination of Activated Partial
Thromboplastin Time (APTT) of human plasma.
[Principle]
When the plasma for test is added with activator (ellagic acid)
and brain cephalin, which is called partial thromboplastin, it
is incubated at 37℃ for a specific period of time to activate
factors XII and XI of the intrinsic pathway of coagulation,
and then in the presence of calcium ions, the fibrinogen is
converted into insoluble fibrin finally. The time of plasma
coagulation after adding calcium chloride measured on the
instrument using the optical nephelometry method is the
APTT of the plasma.
[Reagents Composition]
Kit consists of Reagent 1 (R1) and Reagent 2 (R2).
R1: APTT Reagent: Ellagic acid, rabbit brain cephalin;
R2: CaCl2 Solution: 25mmol/L calcium chloride.
[Storage and Stability]
The reagents store at 2-8℃. Do not freeze! The shelf life is
12 months. Opened vial reagents are stable for 30 days at
2~8℃.
[Instruments]
Semi-automated or automated coagulation analyzers
produced by Rayto Life and Analytical Sciences Co., Ltd.
[Specimen]
1. Nine parts of freshly drawn venous blood are collected
into one part of anticoagulant and 0.109mol/L trisodium
citrate. Centrifuge at room temperature at 3000rpm for 12
minutes. The light yellow liquid on top is the poor platelet
plasma for test.
2. Store the plasma at room temperature and test it within 2
hours.
3. If the plasma can’t be tested timely, separate with a plastic
straw and it is stable for 2 weeks at -20℃. Melt rapidly at
37℃ and gently mix immediately before testing.
Refer to CLSI H21 for further instructions on specimen
collection and preparation.
[Test Procedure]
1. Preparation of Reagent
Before using, gently mix the APTT liquid reagent and
balance it at room temperature.
2. Assay with the semi-automated coagulation analyzer.
Take 50μL plasma and incubate at 37℃ for 1 min.→
Add 50μL APTT Reagent and incubate at 37℃ for 4 min. →
Add 50μL CaCl2 pre-warmed to 37℃, and record the
coagulation time of the plasma.
3. Assay with the automated coagulation analyzer.
Conduct the test according to the operation steps of the
automated coagulation analyzer. For the doses of plasma and
reagent, refer to the above conditions.
[Expected Values]
24~36 sec.
Each laboratory should establish its own reference ranges.
[Interpretation of Test Results]
1. APTT results can be reported in seconds and/ or ratios.
Test results are associated with the reference ranges of the
individual laboratory.
2. Heparin and coumarin therapy may prolong APTT.
[Limitations of the Procedure]
1. The course of coagulation includes a series of reactions
from activation of factors to fibrin formation. Therefore,
test results may be affected by therapeutic drugs
(interferent), test operations, test systems, etc., which
should be considered.
2. Reagent contamination or contamination of sample
containers, straws, etc. by coagulant/anticoagulant may
cause blood coagulation disorders, so strict control is
required.
[Performance Characteristics]
Repeatability: The coefficient of variation (CV) of the
results of repeated tests with QC plasma should not exceed
3.8%.
[Notes]
1. The product is for in vitro diagnosis and used by persons
with major in medical laboratory or trained persons only.
2. The time of incubation at 37℃ after the plasma mixed
with APTT Reagent can be 3 to 5 minutes. APTT values
may be affected if the time is too short or too long.
3. The test temperature should be within 37±0.5℃.
4. To measure APTT, poor platelet plasma is required.
5. During the test, use plastic or siliconized test tubes, straws
and syringes only. Do not use those made of common
glass.
6. The plasma for test must not be anticoagulated by EDTA,
heparin or oxalate.
7. Hemolyzed or lipemic plasma may affect test results.
8. When the HCT of blood is out of the range of 20~55%,
adjust the dose of anticoagulant.
9. QC plasma should be tested at the same time each
working day to eliminate the interference of the
instrument, reagents, abnormal operation, etc.
[References]
1. National Guide to Clinical Laboratory Procedures (Third
Edition). Southeast University Publishing House, 2006.
2. Charles Eby. Clin Chem. 1997, 43(7):1105-1107.
3. Tetrault G. Am J Clin Pathol. 2000, 113(5):741-742.
[Manufacturer]
Rayto Life and Analytical Sciences Co., Ltd.
ADDR: Rayto Industrial Building, Shuangming Blvd South,
East Hi-Tech Park, Guangming New District, 518107
Shenzhen, P.R.China
Website: www.rayto.com
V1.2e
[European Representative]
Shanghai International Holding Corp.GmbH(Europe)
ADDR: Eiffestrasse 80, 20537, Hamburg, Germany
Tel: 0049-40-2513175 Fax: 0049-40-25572

Symbols Explanation

Consult instructions for use

Temperature limit

In vitro diagnostic medical device

Authorized representative in the European

Community

Batch code

Biological risks

Manufacturer

CE Mark

Use-by date

Caution

Catalogue number

Keep top side up

R011MMAR2019V120e

V1.2e