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D‐ Dimer Rapid Test Device
Package Insert
Specimens: Whole Blood/ Plasma Effective Date: 2015‐ 02
For professional in vitro diagnostic use only.
D‐Dimer Rapid Test Device is used for the qualitative detection of D‐dimer in human whole blood and plasma; The test is used as an aid in the assessment and evaluation of patients with suspected disseminated intravascular coagulation (DIC), deep vein thrombosis (DVT), and pulmonary embolism (PE).
During blood coagulation process, fibrinogen is converted to fibrin by the activation of thrombin. The resulting fibrin monomers polymerise to form a soluble gel of non‐cross‐linked fibrin. This fibrin gel is then converted to cross‐linked fibrin by thrombin activated Factor XIII to form an insoluble fibrin clot. Production of plasmin, the major clot‐lysing enzyme, is triggered when a fibrin clot is formed. Although fibrinogen and fibrin are both cleaved by the fibrinolytic enzyme plasmin to yield degradation products, only degradation products from cross‐linked fibrin contain D‐dimer and are called cross‐linked fibrin degradation products. Therefore, fibrin derivatives in human blood or plasma containing D‐dimer are a specific marker of fibrinolysis. The D‐dimer Rapid Test Device (Whole Blood/Plasma) is a rapid test that qualitative detects the presence of D‐dimer in whole blood or plasma specimens at the sensitivity of 500ng/mL. The test utilizes a combination of monoclonal antibodies to selectively detect elevated levels of D‐dimer in whole blood or plasma. At the level of claimed sensitivity, the D‐dimer Rapid Test Cassette (Whole Blood/Plasma) shows no cross‐reactivity interference from the related Troponin I, Troponin T, CK‐MB, Myoglobin or others at high physiological levels.
The D‐Dimer Rapid Test Device (Whole blood/Plasma) detects D‐Dimer through visual interpretation of color development in the internal strip. Anti‐D‐Dimer antibodies are immobilized on the test region of the membrane, and anti‐mouse antibodies immobilized on the control region. During testing, the specimen reacts with anti‐D‐Dimer antibodies conjugated to colored particles and precoated onto the sample pad of the strip. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient D‐Dimer in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
The test contains anti‐ D‐Dimer particles and anti‐ D‐Dimer coated on the membrane.
Individually packed devices Disposable pipettes Buffer in the dilute tubes Package insert | test Each device contains a strip with colored conjugates and reactive reagents precoated at the corresponding regions For adding specimens Phosphate buffered saline with Tween 20 and preservative For operating instructions |
Specimen collection container
Timer
Centrifuge
PRECAUTIONS
This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary
state of the animals does not completely guarantee the absence of transmissible pathogenic agents. It is therefore recommended that these products be treated as potentially infectious, and handled observing usual safety precautions (e.g., do not ingest or inhale).
Avoid cross‐contamination of specimens by using a new specimen collection container for
each specimen obtained.
Read the entire procedure carefully prior to testing.
Do not eat, drink or smoke in the area where the specimens and kits 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.
Do not interchange or mix reagents from different lots.
Humidity and temperature can adversely affect results.
Used testing materials should be discarded according to local regulations.
STORAGE AND STABILITY
The kit should be stored at 2‐30°C until the expiry date printed on the sealedpouch. 
The test must remain in the sealed pouch until use.
Do not freeze.
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 equipments, containers or reagents can lead to false results.
SPECIMEN COLLECTION AND PREPARATION
The D‐Dimer Rapid Test Device (Whole Blood/Plasma) is intended for use with human whole
blood or plasma specimens only.
Only clear, non‐hemolyzed specimens are recommended for use with this test. Whole blood or
Plasma should be separated as soon as possible to avoid hemolysis.
Perform testing immediately after specimen collection. Do not leave specimens at room
temperature for prolonged periods. Plasma specimens may be stored at 2‐8°C for up to 3 days. 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 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.
Containers containing anticoagulants such as EDTA, citrate, or heparin should be used for
whole blood storage.
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 ofspecimens.
If specimens are to be shipped, pack them in compliance with all applicable regulations for
transportation of etiological agents.
Icteric, lipemic, hemolysed, heat treated and contaminated specimens may cause erroneous
results.
Bring tests, specimens, and/or controls to room temperature (15‐30°C) before use.
1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results the assay should be performed within one hour.
2. Transfer 2 drops of whole blood or 1 drop of plasma to the specimen well (S) of the device with the provided disposable pipette, and add 1 drop of buffer. Start thetimer.
OR
Allow 2 hanging drops of fingerstick whole blood to fall into the center of the specimen well (S) of the test device, and add 1 drop of buffer. Start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.
3. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not
interpret the result after 20 minutes.
POSITIVE RESULT:
T NEGATIVE RESULT: C T INVALID RESULT: C T NOTE: | A colored band appears in the control band region (C) and another colored band appears in the T band region. One colored band appears in the control band region (C). No band appears in the test band region (T). Control band fails to appear. Results from any test which has not produced a control band at the specified reading time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor. |
1. The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.
QUALITY CONTROL
Internal procedural controls are included in the test. A colored band appearing in the
control region (C) is considered an internal positive procedural control, confirming sufficient specimen volume and correct procedural technique.
External controls are not supplied with this kit. It is recommended that positive and
negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.
LIMITATIONS OF THE TEST
1. The D‐Dimer Rapid Test Device (Whole Blood/Plasma) is for professional in vitro diagnostic use, and should only be used for the qualitative detection of D‐Dimer.
2. During the process of serum is formed, also fibrinogen is converted to fibrin by the activation of thrombin and it also can be detected by D‐dimer antibody. So serum specimen can’t be used for D‐Dimer Rapid Test Device (Whole Blood/Plasma)
3. Clinical diagnosis should not be based on the result of the D‐dimer rapid test alone. The full clinical context of the patient should be included when making a diagnostic decision m taking into account the clinical signs and other relevant information such as the Wells pre‐test probability score or equivalent.
4. Negative D‐dimer results can occur very occasionally even in the presence of a DVT due to other factors including the age or position of a clot, heparin therapy and when the D‐dimer concentration is below the sensitivity of the test.
EXPECTED VALUE
Elevated levels of D‐dimer are an indication of active fibrinolysis and have been shown in patients with disseminated intravascular coagulation (DIC), deep vein thrombosis (DVT) and pulmonary embolism (PE). Elevated levels of D‐dimer have also been reported in surgery, trauma, sickle cell disease, liver disease, severe infection, sepsis, inflammation, malignancy and in the elderly. D‐dimer levels also rise during normal pregnancy but very high levels are associated with complications.
A positive result indicating active fibrinolysis should be obtained with D‐dimer Rapid Test Devicewhen D‐dimer levels are greater than or equal to the cut‐off of approximately 500ng/ml as measured by an ELISA method.
Sensitivity and Specificity
The D‐Dimer Rapid Test Device (Whole Blood/Plasma) has been evaluated with a leading
commercial D‐dimer EIA test using clinical specimens. The results show that the sensitivity of
the D‐Dimer Rapid Test Device (Whole Blood/Plasma) is 98.6% and the specificity is 98.9%
relative to the leading EIA test.
D‐Dimer Rapid Test Device vs. EIA
Method | EIA Test | Total Results | ||
D‐Dimer Rapid Test Device | Results | Pos. | Neg. | |
Pos. | 68 | 2 | 70 | |
Neg. | 1 | 177 | 178 | |
Total Results | 69 | 179 | 248 | |
Relative Sensitivity: 98.6%(95.7%‐ 100%)*
Relative Specificity: 98.9%(97.3%‐100%)*
Accuracy: 98.8%(97.4%‐ 100%)*
*95% Confidence Interval
1. Gaffney, P.J. D‐dimer History of Discovery, Characterisation and Utility of this and other Fibrin Fragments. Fibrinolysis 7 Suppl 2:2‐8; 1993
2. Lane, D.A. et al. Characterisation of Serum Fibrinogen and Fibrin Fragments Produced During Disseminated Intravascular Coagulation. Haematology. 40: 609‐615; 1978.
3. Scarvelis, D and Wells, P.S. Diagnosis and Treatment of Deep Vein Thrombosis. Can. Med. Assoc. J. 175 (9):1087‐92; 2006
4. Bick, R.L. et al. Diagnostic Efficacy of the D‐dimer assay in Disseminated Intravascular Coagulation (DIC) Thromb. Res. 65:785‐790; 1992.
5. Bick, R.L. et al. Disseminated Intravascular Coagulation: Objective Clinical and Laboratory Diagnosis, Treatment, and Assessment of Therapeutic Response. Semin. Thromb. Hemost. 22(1): 69‐88; 1996.
6. Hunt, F.A. et al. Serum Cross‐Linked Fibrin (XDP) and Fibrinogen/Fibrin Degradation Products (FDP) in Disorders Associated with Activation of the Coagulation or Fibrinolytic Systems. Br. J. Haematol. 60: 715‐722; 1985.
7. Subramanian, R.M. et. al. Does an Immunochromatographic D‐dimer exclude acute lower limb deep venous thrombosis? Emer. Med. Austral. 18: 457‐463; 2006.
8. Runyon, M.S. et. al. Comparison of the Simplify D‐dimer assay performed at the bedside with a laboratory based quantitative D‐dimer assay for the diagnosis of pulmonary embolism in a low prevalence emergency department population. Emerg. Med. J. 25:70‐75; 2008.
D‐ Dimer Rapid Test Device
Package Insert
Specimens: Whole Blood/ Plasma Effective Date: 2015‐ 02
For professional in vitro diagnostic use only.
D‐Dimer Rapid Test Device is used for the qualitative detection of D‐dimer in human whole blood and plasma; The test is used as an aid in the assessment and evaluation of patients with suspected disseminated intravascular coagulation (DIC), deep vein thrombosis (DVT), and pulmonary embolism (PE).
During blood coagulation process, fibrinogen is converted to fibrin by the activation of thrombin. The resulting fibrin monomers polymerise to form a soluble gel of non‐cross‐linked fibrin. This fibrin gel is then converted to cross‐linked fibrin by thrombin activated Factor XIII to form an insoluble fibrin clot. Production of plasmin, the major clot‐lysing enzyme, is triggered when a fibrin clot is formed. Although fibrinogen and fibrin are both cleaved by the fibrinolytic enzyme plasmin to yield degradation products, only degradation products from cross‐linked fibrin contain D‐dimer and are called cross‐linked fibrin degradation products. Therefore, fibrin derivatives in human blood or plasma containing D‐dimer are a specific marker of fibrinolysis. The D‐dimer Rapid Test Device (Whole Blood/Plasma) is a rapid test that qualitative detects the presence of D‐dimer in whole blood or plasma specimens at the sensitivity of 500ng/mL. The test utilizes a combination of monoclonal antibodies to selectively detect elevated levels of D‐dimer in whole blood or plasma. At the level of claimed sensitivity, the D‐dimer Rapid Test Cassette (Whole Blood/Plasma) shows no cross‐reactivity interference from the related Troponin I, Troponin T, CK‐MB, Myoglobin or others at high physiological levels.
The D‐Dimer Rapid Test Device (Whole blood/Plasma) detects D‐Dimer through visual interpretation of color development in the internal strip. Anti‐D‐Dimer antibodies are immobilized on the test region of the membrane, and anti‐mouse antibodies immobilized on the control region. During testing, the specimen reacts with anti‐D‐Dimer antibodies conjugated to colored particles and precoated onto the sample pad of the strip. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient D‐Dimer in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
The test contains anti‐ D‐Dimer particles and anti‐ D‐Dimer coated on the membrane.
Individually packed devices Disposable pipettes Buffer in the dilute tubes Package insert | test Each device contains a strip with colored conjugates and reactive reagents precoated at the corresponding regions For adding specimens Phosphate buffered saline with Tween 20 and preservative For operating instructions |
Specimen collection container
Timer
Centrifuge
PRECAUTIONS
This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary
state of the animals does not completely guarantee the absence of transmissible pathogenic agents. It is therefore recommended that these products be treated as potentially infectious, and handled observing usual safety precautions (e.g., do not ingest or inhale).
Avoid cross‐contamination of specimens by using a new specimen collection container for
each specimen obtained.
Read the entire procedure carefully prior to testing.
Do not eat, drink or smoke in the area where the specimens and kits 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.
Do not interchange or mix reagents from different lots.
Humidity and temperature can adversely affect results.
Used testing materials should be discarded according to local regulations.
STORAGE AND STABILITY
The kit should be stored at 2‐30°C until the expiry date printed on the sealedpouch. The test must remain in the sealed pouch until use.
Do not freeze.
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 equipments, containers or reagents can lead to false results.
SPECIMEN COLLECTION AND PREPARATION
The D‐Dimer Rapid Test Device (Whole Blood/Plasma) is intended for use with human whole
blood or plasma specimens only.
Only clear, non‐hemolyzed specimens are recommended for use with this test. Whole blood or
Plasma should be separated as soon as possible to avoid hemolysis.
Perform testing immediately after specimen collection. Do not leave specimens at room
temperature for prolonged periods. Plasma specimens may be stored at 2‐8°C for up to 3 days. 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 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.
Containers containing anticoagulants such as EDTA, citrate, or heparin should be used for
whole blood storage.
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 ofspecimens.
If specimens are to be shipped, pack them in compliance with all applicable regulations for
transportation of etiological agents.
Icteric, lipemic, hemolysed, heat treated and contaminated specimens may cause erroneous
results.
Bring tests, specimens, and/or controls to room temperature (15‐30°C) before use.
1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results the assay should be performed within one hour.
2. Transfer 2 drops of whole blood or 1 drop of plasma to the specimen well (S) of the device with the provided disposable pipette, and add 1 drop of buffer. Start thetimer.
OR
Allow 2 hanging drops of fingerstick whole blood to fall into the center of the specimen well (S) of the test device, and add 1 drop of buffer. Start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.
3. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not
interpret the result after 20 minutes.
POSITIVE RESULT:
T NEGATIVE RESULT: C T INVALID RESULT: C T NOTE: | A colored band appears in the control band region (C) and another colored band appears in the T band region. One colored band appears in the control band region (C). No band appears in the test band region (T). Control band fails to appear. Results from any test which has not produced a control band at the specified reading time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor. |
1. The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.
QUALITY CONTROL
Internal procedural controls are included in the test. A colored band appearing in the
control region (C) is considered an internal positive procedural control, confirming sufficient specimen volume and correct procedural technique.
External controls are not supplied with this kit. It is recommended that positive and
negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.
LIMITATIONS OF THE TEST
1. The D‐Dimer Rapid Test Device (Whole Blood/Plasma) is for professional in vitro diagnostic use, and should only be used for the qualitative detection of D‐Dimer.
2. During the process of serum is formed, also fibrinogen is converted to fibrin by the activation of thrombin and it also can be detected by D‐dimer antibody. So serum specimen can’t be used for D‐Dimer Rapid Test Device (Whole Blood/Plasma)
3. Clinical diagnosis should not be based on the result of the D‐dimer rapid test alone. The full clinical context of the patient should be included when making a diagnostic decision m taking into account the clinical signs and other relevant information such as the Wells pre‐test probability score or equivalent.
4. Negative D‐dimer results can occur very occasionally even in the presence of a DVT due to other factors including the age or position of a clot, heparin therapy and when the D‐dimer concentration is below the sensitivity of the test.
EXPECTED VALUE
Elevated levels of D‐dimer are an indication of active fibrinolysis and have been shown in patients with disseminated intravascular coagulation (DIC), deep vein thrombosis (DVT) and pulmonary embolism (PE). Elevated levels of D‐dimer have also been reported in surgery, trauma, sickle cell disease, liver disease, severe infection, sepsis, inflammation, malignancy and in the elderly. D‐dimer levels also rise during normal pregnancy but very high levels are associated with complications.
A positive result indicating active fibrinolysis should be obtained with D‐dimer Rapid Test Devicewhen D‐dimer levels are greater than or equal to the cut‐off of approximately 500ng/ml as measured by an ELISA method.
Sensitivity and Specificity
The D‐Dimer Rapid Test Device (Whole Blood/Plasma) has been evaluated with a leading
commercial D‐dimer EIA test using clinical specimens. The results show that the sensitivity of
the D‐Dimer Rapid Test Device (Whole Blood/Plasma) is 98.6% and the specificity is 98.9%
relative to the leading EIA test.
D‐Dimer Rapid Test Device vs. EIA
Method | EIA Test | Total Results | ||
D‐Dimer Rapid Test Device | Results | Pos. | Neg. | |
Pos. | 68 | 2 | 70 | |
Neg. | 1 | 177 | 178 | |
Total Results | 69 | 179 | 248 | |
Relative Sensitivity: 98.6%(95.7%‐ 100%)*
Relative Specificity: 98.9%(97.3%‐100%)*
Accuracy: 98.8%(97.4%‐ 100%)*
*95% Confidence Interval
1. Gaffney, P.J. D‐dimer History of Discovery, Characterisation and Utility of this and other Fibrin Fragments. Fibrinolysis 7 Suppl 2:2‐8; 1993
2. Lane, D.A. et al. Characterisation of Serum Fibrinogen and Fibrin Fragments Produced During Disseminated Intravascular Coagulation. Haematology. 40: 609‐615; 1978.
3. Scarvelis, D and Wells, P.S. Diagnosis and Treatment of Deep Vein Thrombosis. Can. Med. Assoc. J. 175 (9):1087‐92; 2006
4. Bick, R.L. et al. Diagnostic Efficacy of the D‐dimer assay in Disseminated Intravascular Coagulation (DIC) Thromb. Res. 65:785‐790; 1992.
5. Bick, R.L. et al. Disseminated Intravascular Coagulation: Objective Clinical and Laboratory Diagnosis, Treatment, and Assessment of Therapeutic Response. Semin. Thromb. Hemost. 22(1): 69‐88; 1996.
6. Hunt, F.A. et al. Serum Cross‐Linked Fibrin (XDP) and Fibrinogen/Fibrin Degradation Products (FDP) in Disorders Associated with Activation of the Coagulation or Fibrinolytic Systems. Br. J. Haematol. 60: 715‐722; 1985.
7. Subramanian, R.M. et. al. Does an Immunochromatographic D‐dimer exclude acute lower limb deep venous thrombosis? Emer. Med. Austral. 18: 457‐463; 2006.
8. Runyon, M.S. et. al. Comparison of the Simplify D‐dimer assay performed at the bedside with a laboratory based quantitative D‐dimer assay for the diagnosis of pulmonary embolism in a low prevalence emergency department population. Emerg. Med. J. 25:70‐75; 2008.
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