3/ TEST PRINCIPLE 9/ PROCEDURE • Assay Working Range

- LIATEST® D-DI PLUS This assay is based on the change in turbidity of a microparticle suspension 9.1. Calibration The assay working range is 0.27 - 4.00 µg/mL (FEU). However, in case
Immuno-Turbidimetric Assay of D-Dimer that is measured by photometry. A suspension of latex microparticles, Kit reagents are pre-calibrated: this pre-calibration is valid for all the of use of the procedure with automatic dilution of the sample the
coated by covalent bonding with monoclonal antibodies specific for D-dimer, kits of the same lot. corrected assay range is, in effect, up to 20 µg/mL (FEU). If the procedure
• Kit Containing: is mixed with the test plasma whose D-dimer level is to be assayed. An without sample dilution is used, the assay range is 0.27 - 4.00 µg/mL.
– 6 x 5-mL Vials of Buffer (R1) To enter the calibration on the analyzer, scan the barcode printed on the
antigen-antibody reaction takes place, leading to an agglutination of the Assay Value insert across the barcode reader of the instrument. The • Dose-Hook Effect
– 6 x 6-mL Vials of Latex (R2) latex microparticles which induces an increase in turbidity of the reaction calibration values for the lot of reagents being used will subsequently No dose-hook effect has been observed. The D-dimer levels of all tested
IVD medium. This increase in turbidity is reflected by an increase in absorbance, be validated after the two D-dimer control levels have been determined. plasmas containing D-dimer levels as high as 500 µg/mL (FEU) were
(REF 00662) 0459 the latter being measured photometrically. The increase in absorbance is a The calibration curve can be examined on the screen of the analyzer found above the upper limit of the assay working range of 4 µg/mL (i.e.,
April 2023 (00662_EN_07) English 3 function of the D-dimer level present in the test sample. in the “Calibration” menu (see the Reference Manual). > 20 µg/mL due to dilution).
9.2. Patients’ Plasmas • Analytical Specificity
4/ KIT REAGENTS Patients’ plasmas are used undiluted. They are loaded in the The STA® - Liatest® D-Di PLUS is insensitive to fibrinogen and the E
1/ INTENDED USE
An Assay Value insert with a barcode is provided in the box. This barcode instrument (see the Reference Manual of the analyzer model). fragment. A cross-reactivity is observed with the D fragment. However, this
The STA® - Liatest® D-Di PLUS kit is an immuno-turbidimetric assay for the contains the following information: lot number, kit code number, reagent has no effect because in in vivo physiological conditions, the presence of
Then select the test(s) to be performed.
quantitative determination of D-dimer (D-Di) in human citrated plasma for code numbers, expiration date and calibration values. α2-antiplasmin precludes the production of the FDP-D from fibrinogen (2).
use on the analyzers of the STA-R®, STA Compact® and STA Satellite® 9.3. Quality Control
families by professional laboratory personnel. The STA® - Liatest® D-Di • Reagent 1: Tris buffer containing an heterophilic antibody blocking agent It is necessary to run controls to ensure accuracy and reproducibility • Precision
(including rheumatoïd factor). of the results. Two different levels of controls should be used. Prepare Precision studies were performed according to CLSI guideline
PLUS is intended for use in conjunction with a clinical pretest probability
(PTP) assessment model to exclude pulmonary embolism (PE) and deep • Reagent 2: suspension of microlatex particles coated with two different the controls and transfer to the instrument the information contained in EP05-A2 (6) (20 days, 2 runs per day) on STA-R®. The following results
venous thrombosis (DVT) in outpatients suspected of PE or DVT. mouse monoclonal anti-human D-dimer antibodies then stabilized (with the barcodes printed in the Assay Value insert. These controls are have been obtained:
bovine albumin). used undiluted. Within-
_ Repeatability Between-run Within-day Between-day laboratory
STA® - Liatest® D-Di PLUS can be used, in the frame of clinical scores
X Precision Precision Precision
(such as the ISTH score), as an aid in diagnosis and monitoring of These reagents contain sodium azide (< 1 g/L) as a preservative. 9.4. Assay Sample (µg/mL) Precision
disseminated intravascular coagulation (DIC) (5, 8, 14, 18). Refer to the Test Setup of the instrument for full details on how to SD CV SD CV SD CV SD CV SD CV
(µg/mL) (%) (µg/mL) (%) (µg/mL) (%) (µg/mL) (%) (µg/mL) (%)
5/ PRECAUTIONS proceed from this point.
1 0.69 0.045 6.6 0.000 0.0 0.031 4.6 0.023 3.3 0.050 7.3
Store at 2-8 °C. For in vitro diagnostic use only. These reagents are to be used The D-dimer assay of the plasmas to be tested is automatically carried
2/ SUMMARY AND EXPLANATION
only by certified medical laboratory personnel authorized by the laboratory. out by the analyzer at 540 nm as soon as the samples have been 2 2.30 0.055 2.4 0.050 2.2 0.028 1.2 0.000 0.0 0.075 3.2
• Fibrinolysis Take care to use only the reagents from the same kit or the same lot. loaded. If any of the patient results falls outside the working range of
The specific degradation of fibrin (i.e., fibrinolysis) is the reactive Read the Reference Manual of the analyzer model carefully before starting. the assay, the instruments automatically retests the sample in • Comparison Data
mechanism responding to the formation of fibrin (14). Exercise great care in the handling of these reagents and of patient samples. question at an appropriate dilution provided that the procedure with A correlation study on 75 plasmas whose D-dimer level was in the range
Plasmin is the fibrinolytic enzyme derived from the inactive plasminogen. dilution has been chosen (see the Reference Manual). 0.29 - 18.21 µg/mL (FEU) has been carried out with the STA® - Liatest®
Plasminogen is converted into plasmin by plasminogen activators. The Some reagents provided in this kit contain materials of human and/or animal D-Di PLUS and STA® - Liatest® D-Di. Results obtained are the following:
main plasminogen activators are the tissue plasminogen activator (tPA) origin. Whenever human plasma is required for the preparation of these r = 0.998, slope = 1.017, y intercept = 0.004.
and the pro-urokinase which is activated into urokinase (UK) by, among reagents, approved methods are used to test the plasma for the antibodies 10/ RESULTS
to HIV 1, HIV 2 and HCV, and for hepatitis B surface antigen, and results are

STA® - Liatest® D-Di PLUS

others, the contact system of coagulation (1). The D-dimer level (µg/mL) of the plasmas being tested is displayed on the 20
D-dimers
found to be negative. However, no test method can offer complete assurance analyzer dashboard (see the Reference Manual). The result is to be (µg/mL - FEU)
In the bloodstream, plasmin is rapidly and specifically neutralized by that infectious agents are absent. Therefore, users of reagents of these
α2-antiplasmin (1) thereby restricting its fibrinogenolytic activity and interpreted according to the patient’s clinical and biological states.
types must exercise extreme care in full compliance with safety precautions 15
localizing the fibrinolysis on the fibrin clot. in the manipulation of these biological materials as if they were infectious. D-dimer levels are expressed in initial fibrinogen equivalent units (FEU).
On the fibrin clot plasmin degrades fibrin into various products. Antibodies By definition, one FEU is the quantity of fibrinogen initially present that
specific of these products, which do not recognize fibrinogen, have been Waste disposal must be performed in accordance with the applicable local leads to the observed level of D-dimer. The actual quantity of D-dimer is 10
developed (13). The presence of these various fibrin degradation regulations. approx. half of an FEU. For example, a value of 0.50 µg/mL FEU is approx.
products, among which D-dimer is the terminal product, is proof that the For European Union only: 0.25 µg/mL (actual D-dimer). 5
fibrinolytic system is in action in response to coagulation activation. – Must not be disposed together with household garbage. Do not allow Ensure that the values obtained for the controls are within the ranges stated D-dimers (µg/mL - FEU)
product to reach sewage system. Avoid discharges into streams and soils. in the Assay Value insert provided in the control box. If the control values are 0
Liquid and solid waste must be collected selectively in specific containers. outside the stated ranges, check all components of the test system to 0 5 10 15 20
Dispose of containers to an approved waste treatment plant for incineration. ensure that all are functioning correctly, i.e., assay conditions, reagents, STA® - Liatest® D-Di
– Safety Data Sheet (SDS) available on request.
integrity of the plasmas being tested, etc. If necessary, repeat the tests.
– For a user in the European Union and in countries with identical
regulatory regime (Regulation 2017/746/EU on In vitro Diagnostic 14/ CLINICAL PERFORMANCES
Medical Devices): if, during the use of this device or as a result of its use, 11/ LIMITATIONS A clinical multi-center study using STA® - Liatest® D-Di was conducted over
a serious incident has occurred, please report it to the manufacturer and
to your national authority. • Cloudy plasmas may lead to an under-estimation of the D-dimer level. the United States, Europe and Canada. This study was performed
(Ensure that the absorbance value at 540 nm of the plasma diluted 1:6 according to CLSI H59-A (17) to demonstrate the ability of STA® - Liatest®
with STA® - Owren-Koller is < 0.6). ln a study using human lipids, the D-Di to safely rule-out PE and DVT by using samples of outpatients
6/ SPECIMEN COLLECTION AND TREATMENT assay has shown to be insensitive to triglycerides up to 5 g/L. prospectively and consecutively enrolled in emergency departments or
Sample collection must be in conformity with the recommendations for outpatient clinics. All patients were evaluated with the Wells’ model to
haemostasis tests.
• Concentrations of fibrinogen degradation products greater than 15 µg/mL
may lead to an over-estimation of the D-dimer level. assess their pretest probability (PTP) score (Low, Moderate or High).
• Blood (9 vol.) is collected in 0.109 M (i.e., 3.2 %) trisodium citrate • The presence of rheumatoid factor at a level greater than 1000 IU/mL 14.1. Pulmonary Embolism
• Clinical Applications anticoagulant (1 vol.) (10, 11). may lead to an over-estimation of the D-dimer level. 9 sites were involved in this study. 1130 samples of patients with a low or
– Thromboses
One of the main clinical applications of D-dimer is the exclusion of • Centrifugation: 15 minutes at 2000-2500 g. Alternatively, centrifuge the • The STA® - Liatest® D-Di PLUS is insensitive to the following substances:
moderate PTP were used for the final analysis. Among these samples,
specimen tube at a speed and time required to produce platelet poor 70 coming from a US banked samples, collected during a similar clinical
venous thrombo-embolism (VTE) when the D-dimer level is inferior to hemoglobin (up to 2 g/L), conjugated bilirubin (up to 290 mg/L),
plasma (< 10000 platelets/µL). The alternative centrifugation process study (19), were used to enrich the prospective study population (25).
a predefined cut-off. A D-dimer test should be used in conjunction with should be validated locally. Please refer to CLSI H21 for more details. unconjugated bilirubin (up to 200 mg/L), unfractionated heparin (up to
Patients with a low or moderate PTP score and a positive D-dimer result
a well validated clinical score to safely exclude VTE in outpatients with 2 IU/mL), low molecular weight heparin (up to 2 anti-Xa IU/mL). Tests
• Plasma storage: 8 hours at 20 ± 5 °C or a high PTP score were referred to imaging studies. Patients with a low
a low or moderate clinical score (13) provided it was previously performed according to CLSI guideline EP07-A2 (9).
validated for this intended use by a management study carried out 1 month at –20 °C. Thaw the sample at 37 °C, allow or moderate PTP score and a negative D-dimer result were followed for
according to the requirements of the CLSI guideline H59-A (17). sufficient time to obtain complete thawing. • The presence of anti-bovine albumin and/or anti-mouse antibodies (HAMA) a three-month period of time to evaluate a potential development of PE.
in certain subjects may lead to an over-estimation of the D-dimer level. The overall prevalence of PE (low and moderate PTP patients with positive
Age-adjusted cut-off values for DVT and PE suspicion have been However, the presence of the blocking agent minimizes the interferences
shown to increase the specificity of D-Dimer and reduce the number of imaging) in the prospective study population was 8.4 % with 2.7 % in the
7/ REAGENT PREPARATION AND STORAGE from heterophilic antibodies (including rheumatoid factor and HAMA).
unnecessary imaging studies in patient populations greater than US population and 11.4 % in the European/Canadian population.
• Preparation
• Patient with distal DVT may have a normal D-dimer level (17). Sensitivity, specificity, negative predictive value (NPV) and positive
50 years (20, 21, 23, 24). Allow Reagent 1 and 2 to stand at room temperature (18-25 °C) for
It is recommended that the D-dimer assay be performed before predictive value (PPV) with upper and lower limit of 95 % confidence
15 minutes before use. Mix the reagents by gentle swirling of the vials • D-dimer assay should not be used in patients with high PTP score (17).
intervals (CI) were calculated in the overall study population and
initiation of any anticoagulant treatment (4). without creating any bubbles. Then, place a new STA® - mini Reducer
In thrombotic states, the D-dimer level may increase after • The D-dimer level increases during pregnancy (16). It also rises with age separately for the US population and the European/Canadian
(REF 00797) and the perforated cap on each vial. (3, 22). population with the clinical cut-off of 0.50 µg/mL (FEU) in the (low +
anticoagulant treatment withdrawal. This increase may be correlated
with a thrombosis recurrence risk, especially with idiopathic • Storage moderate) PTP group of patients.
thromboses. Therefore, some authors suggest that the evolution of the The reagents in intact vials are stable until the expiration date indicated 12/ REFERENCE INTERVAL Overall study population:
D-dimer level is a useful tool for the evaluation of risk of VTE recurrence on the box label, when stored at 2-8 °C.
With the STA® - mini Reducer and perforated cap in place the stability of The normal level of D-dimer in adult population is less than 0.50 µg/mL Reference (imaging or 3-month follow-up)
in such patients (12, 14, 17, 18). Overall
Reagents 1 and 2 after opening and in their original vials is 15 days on (expressed in FEU) (3). However, each laboratory should determine its own Positive Negative Total
– Disseminated Intravascular Coagulation (DIC)
In DIC the fibrinolytic system is activated and therefore the D-dimer analyzers of the STA-R®, STA Compact® and STA Satellite® families. normal D-dimer level.
Positive 98 252 350
level increases. D-dimer assays can help in the diagnosis of DIC, and In a study carried out using 107 samples from apparent healthy donors, 92.5 %
of values were found below 0.50 µg/mL (FEU) with STA® - Liatest® D-Di. D-dimer Negative 3 777 780
in DIC patients’ management (5, 8, 14, 18). 8/ REAGENTS AND EQUIPMENT REQUIRED BUT NOT PROVIDED
– Activation States of Coagulation Total 101 1029 1130
• STA® - Owren-Koller (REF 00360).
The D-dimer level increases during the activation states of coagulation 13/ PERFORMANCE CHARACTERISTICS Sensitivity (95 % CI) = 97.0 % (91.6 % - 99.4 %)
because such states induce the increased production of thrombin • STA® - D-Di Control (REF 00868) on the analyzer of the STA-R® and STA
Compact® families only or STA® - Liatest® Control N + P (REF 00526). Specificity (95 % CI) = 75.5 % (72.8 % - 78.1 %)
which is followed by the formation of fibrin and subsequently leads to • Limit of Detection
Analyzers of the STA-R®, STA Compact® or STA Satellite® families. The limit of detection was assessed according to CLSI guideline EP17-A NPV (95 % CI) = 99.7 % (99.2 % - 100.0 %)
enhanced fibrinolysis, the latter being most frequently reactive. • PPV (95 % CI) = 25.5 % (23.5 % - 27.7 %)
Increased levels of D-dimer have been reported in the following cases: STA® - mini Reducer (REF 00797). (7). The limit of detection on the analyzers of the STA-R®, STA Compact®
• and STA Satellite® families is 0.27 µg/mL (FEU).
post-operative period, cancers, bleeding, severe infections (14, 18).
• Common clinical laboratory equipment and materials.
 US prospective study population: European/Canadian prospective study population:
Reference (imaging or 3-month follow-up) Reference (imaging or 3-month follow-up)
US Europe and Canada
Positive Negative Total Positive Negative Total
Positive 8 78 86 Positive 63 256 319
D-dimer Negative 1 271 272 D-dimer Negative 0 292 292
Total 9 349 358 Total 63 548 611
Sensitivity (95 % CI) = 88.9 % (51.8 % - 99.7 %) Sensitivity (95 % CI) = 100 % (94.3 % - 100 %)
Specificity (95 % CI) = 77.7 % (72.9 % - 81.9 %) Specificity (95 % CI) = 53.3 % (49.0 % - 57.5 %)
NPV (95 % CI) = 99.6 % (98.0 % - 100.0 %) NPV (95 % CI) = 100 % (98.7 % - 100 %)
PPV (95 % CI) = 9.3 % (4.1 % - 17.5 %) PPV (95 % CI) = 19.7 % (15.5 % - 24.5 %)
European/Canadian prospective study population: The Summary of Safety and Performance of this device can be
downloaded from the European Database (EUDAMED) when serviceable
Reference (imaging or 3-month follow-up) and is also available through your local representative.
Europe and Canada
Positive Negative Total
Positive 74 145 219
D-dimer Negative 1 482 483
REFERENCES
Total 75 627 702 1. BACHMANN F.: “Fibrinolysis” in “Thrombosis and Haemostasis”, Verstraete M., Vermylen J.,
Lijnen H.R., Arnout J., Leuven: International Society on Thrombosis and Haemostasis and
Sensitivity (95 % CI) = 98.7 % (92.8 % - 100.0 %) Leuven University Press, 227-265, 1987.
Specificity (95 % CI) = 76.9 % (73.4 % - 80.1 %) 2. GAFFNEY P.J., LONGSTAFF C.: “An overview of fibrinolysis” in “Haemostasis and thrombosis:
basic principles and clinical practice”, Bloom, A. L., Forbes, C. D., Tuddenham, E. G. D. and
NPV (95 % CI) = 99.8 % (98.9 % - 100.0 %) Thomas, D. P. (Eds.). Churchill Livingstone, 549-573, 1994
PPV (95 % CI) = 33.8 % (27.6 % - 40.5 %) 3. GIANSANTE C., FIOTTI N., CATTIN L., DA COL P.G.: “Fibrinogen, D-dimer and thrombin-
antithrombin complexes in a random population sample: relationships with other cardiovascular
US banked samples: risk factors”. Thromb. Haemostasis, 71, 5, 581-586, 1994.
Sensitivity and specificity were calculated in the US banked samples 4. COUTURAUD F., KEARON C., BATES S.M., GINSBERG J.S.: “Decrease in sensitivity of
D-dimer for acute venous thromboembolism after starting anticoagulant therapy”. Blood Coag.
with the clinical cut-off of 0.50 µg/mL (FEU) in the (low + moderate) Fibrinolysis, 13, 241-246, 2002.
PTP group of patients. 5. BAKHTIARI K., MEIJERS J.C.M., DE JONGE E., LEVI M.: “Prospective validation of the
Reference (imaging or 3-month follow-up) International Society of Thrombosis and Haemostasis scoring system for disseminated
Banked intravascular coagulation”. Crit. Care Med., 32, 12, 2004.
Positive Negative Total 6. CLSI Document EP05-A2: “Evaluation of precision performance of quantitative measurement
methods; approved guideline”. Second Edition, 24, 25, 2004.
Positive 16 29 45
7. CLSI Document EP17-A: “Protocols for determination of limits of detection and limits of
D-dimer Negative 1 24 25 quantitation; approved guideline”. First Edition, 24, 34, 2004.
Total 17 53 70 8. LEHMAN C.M., WILSON L.W., RODGERS G.M.: “Analytic Validation and Clinical Evaluation of
the STA LIATEST Immunoturbidimetric D-Dimer Assay for the Diagnosis of Disseminated
Sensitivity (95 % CI) = 94.1 % (71.3 % - 99.9 %) Intravascular Coagulation”. Am. J. Clin. Pathol., 122, 178-184, 2004.
9. CLSI Document EP07-A2: “Interference testing in clinical chemistry; approved guideline”.
Specificity (95 % CI) = 45.3 % (31.6 % - 59.6 %) Second Edition, 25, 27, 2005.
14.2. Deep Venous Thrombosis 10. CLSI Document GP41-A6: “Procedures for the collection of diagnostic blood specimens by
venipuncture; approved standard”. Sixth Edition, 27, 26, 2007.
16 sites were involved in this study. 980 samples of patients with a
11. CLSI Document H21-A5: “Collection, transport, and processing of blood specimens for testing
low or moderate PTP were used for the final analysis (26). plasma - based coagulation assays and molecular hemostasis assays; approved guideline”.
Patients with a low or moderate PTP score and a positive D-dimer Fifth Edition, 28, 5, 2008.
result or a high PTP score were referred to imaging studies. Patients 12. LEGNANI C., PALARETI G., COSMI B., CINI M., TOSETTO A., TRIPODI A.: “Different cut-off
values of quantitative D-dimer methods to predict the risk of venous thromboembolism
with a low or moderate PTP score and a negative D-dimer result were recurrence: a post-hoc analysis of the PROLONG study”. Haematologica, 93(6), 2008.
followed for a three-month period of time to evaluate a potential 13. RIGHINI M., PERRIER A., DE MOERLOOSE P., BOUNAMEAUX H.: “D-Dimer for venous
development of DVT. thromboembolism diagnosis: 20 years later”. Thromb. Haemostasis, 6, 1059-1071, 2008.
The overall prevalence of DVT (low and moderate PTP patients with 14. ADAM S.S., KEY N.S., GREENBERG C.S.: “D-dimer antigen: current concepts and future
prospects”. Blood, 113, 13, 2009.
positive imaging) in the prospective study population was 8.4 % with
15. COSMI B., LEGNANI C., TOSETTO A., PENGO V., GHIRARDUZZI A., TESTA S., PRISCO D.,
6.0 % in the US population and 9.8 % in the European/Canadian POLI D., TRIPODI A., MARONGIU F., PALARETI G.: “Usefulness of repeated D-dimer testing
population. after stopping anticoagulation for a first episode of unprovoked venous thromboembolism: the
Sensitivity, specificity, negative predictive value (NPV) and positive PROLONG II prospective study”. Blood, 115, 3, 2010.
predictive value (PPV) with upper and lower limit of 95 % confidence 16. SZECSI P.B., JØRGENSEN M., KLAJNBARD A., ANDERSEN M.R., COLOV N.P., STENDER
S.: “Haemostatic reference intervals in pregnancy”. Thromb. Haemostasis, 103, 718-727, 2010.
intervals (CI) were calculated in the overall study population and
17. CLSI Document H59-A: “Quantitative D-dimer for the exclusion of venous thromboembolic
separately for the US population and the European/Canadian disease; approved guideline”. First Edition, 31, 6, 2011.
population with the STA® - Liatest® D-Di clinical cut-off of 0.50 µg/mL 18. BATES S.M.: “D-Dimer Assays in Diagnosis and Management of Thrombotic and Bleeding
(FEU) in the (low + moderate) PTP group of patients. Disorders”. Semin Thromb Hemost, 38, 673-682, 2012.
19. KLINE J.A., HOGG M.M., COURTNEY D.M., MILLER C.D., JONES A.E., SMITHLINE H.A.:
Overall prospective study population: “D-dimer Threshold Increase with Pretest Probability Unlikely for Pulmonary Embolism to
Decrease Unnecessary Computerized Tomographic Pulmonary Angiography”. Thromb.
Reference (imaging or 3-month follow-up) Haemostasis, 10, 572-581, 2012.
Overall
Positive Negative Total 20. PENALOZA A., ROY P.M., KLINE J., VERSCHUREN F., LE GAL G., QUENTIN-GEORGET S.,
DELVAU N., THYS F.: “Performance of age-adjusted D-dimer cut-off to rule out pulmonary
Positive 85 401 486 embolism”. Journal of Thrombosis and Haemostasis, 10, 1291-1296, 2012.
D-dimer Negative 0 494 494 21. ANURAG G., RAJA A.S., IVAN K., KHORASANI R.: “Assessing 2 D-dimer age-adjustment
strategies to optimize computed tomographic use in ED evaluation of pulmonary embolism”.
Total 85 895 980 American Journal of Emergency Medicine, 32, 1499-1502, 2014.
22. RIGHINI M., VAN ES J., DEN EXTER P.L. et al.: “Age-Adjusted D-Dimer Cutoff Levels to Rule
Sensitivity (95 % CI) = 100 % (95.8 % - 100 %) Out Pulmonary Embolism - The ADJUST-PE Study”. JAMA, 311(11), 1117-1124, 2014.
Specificity (95 % CI) = 55.2 % (51.9 % - 58.5 %) 23. SHARP A.L., VINSON D.R., ALAMSHAW F., HANDLER J., GOULD M.K.: “An age-adjusted
NPV (95 % CI) = 100 % (99.3 % - 100 %) D-dimer threshold for emergency department patients with suspected pulmonary embolus:
accuracy and clinical implications”. Annals of emergency medicine, 2, 249-257, 2015.
PPV (95 % CI) = 17.5 % (14.2 % - 21.2 %)
24. GOODWIN A.J., HIGGINS R.A., MOSER K.A., SMOCK K.J., CHANDLER W.L., KOTTKE-
MARCHANT K., HARTMAN S.K. et al.: “Issues surrounding age-adjusted D-dimer cutoffs that
US prospective study population: practicing physicians need to know when evaluating patients with suspected pulmonary
embolism”. Annals of internal medicine, 5, 361-363, 2017.
Reference (imaging or 3-month follow-up)
US 25. PERNOD G. et al.: “Validation of the STA - Liatest D-Di assay for exclusion of pulmonary
Positive Negative Total embolism according to the latest Clinical and Laboratory Standards Institute/Food and Drug
Administration guideline: results of a multicenter management study”. Blood Coagulation and
Positive 22 145 167 Fibrinolysis, 28, 3, 254-260, 2017.
D-dimer Negative 0 202 202 26. PERNOD G. et al.: “Validation of the STA - Liatest D-Di assay for exclusion of proximal deep
vein thrombosis according to the latest Clinical and Laboratory Standards Institute/Food and
Total 22 347 369 Drug Administration guideline: results of a multicenter management study”. Blood Coagulation
and Fibrinolysis, 29, 6, 562-566, 2018.
Sensitivity (95 % CI) = 100 % (84.6 % - 100 %)
Specificity (95 % CI) = 58.2 % (52.8 % - 63.5 %)
NPV (95 % CI) = 100 % (98.2 % - 100 %)
PPV (95 % CI) = 13.2 % (8.4 % - 19.3 %)

Significant changes are indicated by dotted lines in the margin.

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