D-Dimer Test Cassette
REF FI-DDM-402
English
Concentrations
Clinical Reference
＜0.5 mg/L
Healthy
0.5 ~ 1.5 mg/L
Low DVT and PE risk
1.5 ~ 3 mg/L
Moderate DVT and PE risk
3 ~ 5 mg/L
High DVT and PE risk
＞5 mg/L
High DVT and PE risk (Increased mortality)
Index of Symbols
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instructions for use
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Authorized
European Community
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Hangzhou AllTest Biotech Co., Ltd.
MedNet EC-REP GmbH
Borkstrasse 10
48163 Muenster
Germany
(Whole Blood/Plasma)
Package Insert
A test for measuring D-Dimer in whole blood or plasma with the use of fluorescence
Immunoassay Analyzer.
For professional in vitro diagnostic use only.
【
INTENDED USE】
The D-Dimer Test Cassette (Whole Blood/Plasma) is based on Fluorescence Immunoassay to
measure D-Dimer in whole blood or plasma as an aid in the diagnosis of DVT and PE.
【
SUMMARY】
D-dimer (or D dimer) is a fibrin degradation product (or FDP), a small protein fragment present
in the blood after a blood clot is degraded by fibrinolysis. Its formation or increase reflects the
activation of coagulation and fibrinolysis system, and its plasma level can represent the
production of thrombin active agent fibrin in vivo. It can be used as an indicator of thrombosis in
the body. The D-dimer content in patients with thrombosis is significantly elevated1.
In addition, studies have shown that low levels of D-Dimer (0.1-0.5mg/L) are closely related to
the occurrence of cardiovascular diseases, and high levels of D-Dimer may be early exclusion
diagnostic indicators for DVT and PE
【PRINCIPLE】
The D-Dimer Test Cassette (Whole Blood/Plasma) detects D-Dimer based on Fluorescence
Immunoassay. The sample moves through the strip from sample pad to absorbent pad. If the
specimen contains D-Dimer, it attaches to the fluorescent microspheres-conjugated
anti-D-Dimer antibodies. Then the complex will be captured by the capture antibodies coated
on the nitrocellulose membrane (Test line). The concentration of D-Dimer in the sample
correlates with the fluorescence signal intensity captured on the T line. According to the
fluorescence intensity of the test and the standard curve, the concentration of D-Dimer in the
sample can be calculated by Analyzer to show D-Dimer concentration in specimen.
【
REAGENTS】
The test includes anti-D-Dimer antibody coated fluorphores and anti-D-Dimer antibody coated
on the membrane.
PRECAUTIONS】
【
1. For professional in vitro diagnostic use only.
2. Do not use after the expiration date indicated on the package. Do not use the test if the foil
pouch is damaged. Do not reuse.
3. Avoid cross-contamination of specimens by using a new specimen collection container for
each specimen obtained.
4. Do not eat, drink or smoke in the area where the specimens and tests are handled. Handle
all specimens as if they contain infectious agents. Observe established precautions against
microbiological hazards throughout the procedure and follow standard procedures for proper
disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves
and eye protection when specimens are assayed.
5. Do not interchange or mix reagents from different lots.
6. Humidity and temperature can adversely affect results.
7. Used testing materials should be discarded in accordance with local regulations.
8. Read the entire procedure carefully prior to any testing.
9. The D-Dimer Test Cassette should only be used with the Analyzer by approved medical
professionals.
【
STORAGE AND STABILITY】
1. The kit should be stored at 4-30 °C before the expiry date printed on the sealed pouch.
2. The test must remain in the sealed pouch until use.
3. Do not freeze.
4. Care should be taken to protect the components of the kit from contamination. Do not use if
there is evidence of microbial contamination or precipitation. Biological contamination of
dispensing equipment, containers or reagents can lead to false results.
SPECIMEN COLLECTION AND PREPARATION】
【
Preparation
Before performing the test, please make sure that all components are brought to room
temperature (15-30 °C). Cold buffer solution or moisture condensation on the membrane can
lead to invalid test results.
Sample Handling
1. Collect the specimen according to standard procedures.
To collect Fingerstick Whole Blood specimens:
Wash the patient’s hand with soap and warm water or clean with an alcohol swab.
Allow to dry.
Massage the hand without touching the puncture site by rubbing down the hand
towards the fingertip of the middle or ring finger.
Puncture the skin with a sterile lancet. Wipe away the first sign of blood.
Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over
the puncture site.
2. Do not leave specimens at room temperature for prolonged periods. Plasma specimens may
be stored at 2-8 °C for up to half-day, for long term storage, specimens should be kept below
-20 °C. Whole blood collected by venipuncture should be stored at 2-8 °C if the test is to be run
within half-day of collection. Do not freeze whole blood specimens. Whole blood collected by
finger stick should be tested immediately.
3. Bring specimens to room temperature prior to testing. Frozen specimens must be
completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of
specimens.
4. EDTA K2, Heparin sodium, Citrate sodium and Potassium Oxalate can be used as the
anticoagulant for collecting the specimen.
Sample Dilution / Sample Stability
1. The specimen can be added directly with the micro pipette into the buffer.
2. Close the tube and shake the sample by hand vigorously for approximately 10 seconds to
mix the sample and dilution buffer
3. Let the diluted sample homogenize for approximately 1 minute.
4. It is best to place the diluted sample on an ice pack and leave the sample at room
2
.
temperature for no more than 8 hours.
【
MATERIALS】
• Test Cassettes • Specimen Collection Tubes with dilution buffer
• ID Card • Package Insert
• Droppers • Lancets
• Timer • Centrifuge • Fluorescence Immunoassay Analyzer
• Pipette • Specimen Collection Containers
【
DIRECTIONS FOR USE】
Refer to Fluorescence Immunoassay Analyzer Operation Manual for the complete instructions
on use of the analyzer. The test should be conducted in room temperature.
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C)
prior to testing.
1. Turn on the Analyzer power. Then according to the need, select “standard test” or “Quick
test” mode.
2. Take out the ID card and insert it into the Analyzer port.
3. To use a pipette: Pipette 10 μL of sample into the buffer tube; mix the specimen and the
buffer well.
To use a dropper: Without squeezing the dropper, put the glass capillary tube end in
contact with the liquid sample surface tilted. Liquid sample will migrate into the capillary
tube automatically. Note: Make sure do not take the plastic part of the dropper in contact
with the sample.
Then release the sample into the buffer tube by squeezing the bulb at the top end of the
dropper vertically. Wash the tube 2-3 times by squeezing the top bulb. Mix the sample and
the buffer well.
4. To use a pipette: Pipette 75 μL of diluted specimen into the sample well of the cassette.
Start the timer at the same time.
To use a dropper: Immerse the tube end (plastic tube) into the diluted sample; squeeze
the top bulb to absorb the solution into the lower bulb (no more than the lower bulb).
Squeeze the top bulb vertically to release the diluted solution into the sample well of the
test cassette and start the timer.
5. There are two test modes for Fluorescence Immunoassay Analyzer, Standard Test mode
and Quick Test mode. Please refer to the user manual of Fluorescence Immunoassay
Analyzer for details.
“Quick test” mode: After 15 minutes of adding sample，Insert the test cassette into the
Analyzer, click “QUICK TEST”, fill the test information and click "NEW TEST" immediately. The
Analyzer will automatically give the test result after a few seconds.
“Standard test” mode: Insert the test cassette into the Analyzer immediately after adding
specimen, click “STANDARD TEST”, fill the test information and click "NEW TEST" at the
same time, The Analyzer will automatically countdown 15 minutes. After the countdown, the
Analyzer will give the result at once.
【
INTERPRETATION OF RESULTS】
Results read by Fluorescence Immunoassay Analyzer.
The result of tests for D-Dimer is calculated by Fluorescence Immunoassay Analyzer and
display the result on the screen. For additional information, please refer to the user manual of
Fluorescence Immunoassay Analyze.
Linearity range of D-Dimer Test is 0.1~10 mg/L.
Reference range:＜0.5 mg/L
【QUALITY CONTROL】
Each D-Dimer Test Cassette contains internal control that satisfies routine quality control
requirements. This internal control is performed each time a sample is tested. This control
indicates that the test cassette was inserted and read properly by Fluorescence Immunoassay
Analyzer. An invalid result from the internal control causes an error message on Fluorescence
Immunoassay Analyzer indicating that the test should be repeated. An invalid result from the
internal control causes an “N/A” message on Fluorescence Immunoassay Analyzer. Insufficient
specimen volume or incorrect procedural techniques are the most likely reasons for control
failure. Review the procedure and repeat the test with a new test. If the problem persists,
discontinue using the test kit immediately and contact your local distributor.
【
LIMITATIONS】
1. The D-Dimer Test Cassette (Whole Blood/Plasma) is for professional in vitro diagnostic use,
and should only be used for the quantitative detection of D-Dimer .
2. The D-Dimer Test Cassette (Whole Blood/Plasma) will only indicate the presence of
Materials Provided
Materials Required But Not Provided
D-Dimer in the specimen and should not be used as the sole criterion for evaluating DVT and
PE.
3. Like with all diagnostic tests, a confirmed diagnosis should only be made by a physician
after all clinical and laboratory findings have been evaluated.
4. High concentrations of D-Dimer may produce a dose hook effect, resulting in incorrect
interpretation of D-Dimer levels. High dose hook effect has not been observed with this test up
to 10 mg/L of D-Dimer .
5. The hematocrit level of the whole blood should be between 25% and 65%.
6. The results of D-Dimer Tests are based on measuring the levels of D-Dimer in a specimen. It
should not be used as the sole criterion for treatment decisions. If the result is positive, other
clinical findings and alternative test methods are recommended to reach proper medical
treatments.
【
EXPECTED RESULTS】
【PERFORMANCE CHARACTERISTICS】
1.Accuracy
The test deviation is ≤±15%.
2.Sensitivity
The D-Dimer Test Cassette (Whole Blood/Plasma) can detect levels of D-Dimer as low as 0.1
mg/L in whole blood or plasma.
3. Detection range
0.1 ~10 mg/L
4. Linearity range
0.1 ~ 10 mg/L , R≥0.990
5. Precision
Intra-lot precision
Within-run precision has been determined by using 10 replicates of 2 specimens containing 0.1
mg/L, 0.5 mg/L of D-Dimer. C.V. is ≤ 15%.
Inter-lot precision
Between-run precision has been determined by using 10 replicates for each of three lots using
2 specimens containing 0.1 mg/L, 0.5 mg/L of D-Dimer. C.V. is ≤15%.
6.Cross-reactivity
Cross-reactivity studies were carried out with following analytes.
HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, anti-syphilis IgG, anti-HIV IgG, anti-H.pylori IgG,
anti-MONO IgM , anti-Rubella IgG, anti-Rubella IgM, anti-CMV IgG, anti-CMV IgM, anti-Toxo
IgG and anti-Toxo IgM positive specimens. The results showed no cross-reactivity.
7.Interfering Substances
The following potentially interfering substances were added to D-dimer negative and positive
specimens, respectively.
Acetaminophen: 20 mg/dL Caffeine: 20 mg/dL
Acetylsalicylic Acid: 20 mg/dL Gentisic Acid: 20 mg/dL
Ascorbic Acid: 20mg/dL Albumin: 10,500 mg/dL
Creatin: 200 mg/dL Hemoglobin: 1,000 mg/dL
Bilirubin: 1,000 mg/dL Oxalic Acid: 600 mg/dL
Cholesterol: 800 mg/dL Triglycerides: 1,600 mg/dL
None of the substances at the concentration tested interfered in the assay.
8. Method comparison
The D-Dimer assay was compared with the results obtained with ADVIA2400 for 90 samples.
The correlation coefficient(r) is 0.983.
【
LITERATURE REFERENCES】
1. Adam S S, Key N S, Greenberg C S. D-dimer antigen: current concepts and future
prospects[J]. Blood, 2009, 113(13):2878.
2. General Practice Notebook > D-dimer. Retrieved September 2011
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Revision date: 2022-09-22
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