164 Semiquantitative Latex Agglutination D-Dimer Assay
Original Article
Sensitivity and Specificity of the Semiquantitative Latex Agglutination
D-Dimer Assay for the Diagnosis of Acute Pulmonary Embolism
as Defined by Computed Tomographic Angiography
DAVID A. FROEHLING, MD; PETER L. ELKIN, MD; STEPHEN J. SWENSEN, MD; JOHN A. HEIT, MD;
V. SHANE PANKRATZ, PHD; AND JAY H. RYU, MD
Objective: To determine the sensitivity and specificity
of the semiquantitative latex agglutination plasma fibrin
D-dimer assay for the diagnosis of acute pulmonary embo-
lism by using computed tomographic (CT) angiography as
the diagnostic reference standard.
Patients and Methods: From January 1, 1998, to June
26, 2000, patients who had both semiquantitative latex
agglutination plasma fibrin D-dimer testing and CT angi-
ography for suspected acute pulmonary embolism were
selected for the study. A D-dimer value greater than 250
ng/mL was considered positive for thromboembolic dis-
ease. Diagnosis of acute pulmonary embolism was based
solely on the interpretation of the CT angiogram. The D-
dimer assay results were then compared with the CT
angiographic diagnoses.
Results: Of 946 CT studies, 172 (18%) were positive
for acute pulmonary embolism. The D-dimer assay was
positive for 612 (65%) of the 946 patients. For acute pul-
A n estimated 200,000 patients in the United States have
acute pulmonary embolism annually, and it is the
primary cause of death for about 60,000 of these patients.1,2
Early diagnosis and prompt initiation of anticoagulation
medication markedly reduce this mortality rate.3 However,
diagnosing acute pulmonary embolism is often difficult. A
recent 5-year autopsy study from our institution found that
the cause of death in 4% of patients was acute pulmonary
embolism. This diagnosis was considered antemortem in
only half of these patients, and testing for thromboembolic
disease was performed in only 22%.4 Acute pulmonary
embolism is probably the most common preventable cause
of hospital deaths.5
From the Division of Area General Internal Medicine (D.A.F., P.L.E.),
Department of Radiology (S.J.S.), Division of Cardiovascular Dis-
eases and Internal Medicine (J.A.H.), Division of Biostatistics
(V.S.P.), and Division of Pulmonary and Critical Care Medicine and
Internal Medicine (J.H.R.), Mayo Clinic College of Medicine, Roches-
ter, Minn.
This study was supported in part by a grant from Mayo Foundation.
Address reprint requests and correspondence to David A. Froehling,
MD, Division of Area General Internal Medicine, Mayo Clinic College
of Medicine, 200 First St SW, Rochester, MN 55905 (e-mail:
froehling.david@mayo.edu).
Mayo Clin Proc. 2004;79:164-168
For personal use. Mass reproduce only with permission from Mayo Clinic Proceedings.
Mayo Clin Proc, February 2004, Vol 79
monary embolism, the D-dimer assay had a sensitivity of
0.83 (95% confidence interval [CI], 0.76-0.88), a specificity
of 0.39 (95% CI, 0.36-0.43), a negative likelihood ratio of
0.44 (95% CI, 0.32-0.62), and a negative predictive value of
0.91 (95% CI, 0.87-0.94).
Conclusions: The semiquantitative latex agglutina-
tion plasma fibrin D-dimer assay had moderate sensitivity
and low specificity for the diagnosis of acute pulmonary
embolism. When used alone, the results of this test were
insufficient to exclude this serious and potentially fatal
disorder. Approximately two thirds of our patients had
positive D-dimer assays and required further evaluation to
exclude acute pulmonary embolism.
Mayo Clin Proc. 2004;79:164-168
CI = confidence interval; CT = computed tomography;
ELISA = enzyme-linked immunosorbent assay
Historically, the most common test for the diagnosis of
acute pulmonary embolism has been the radionuclide (ven-
tilation-perfusion) lung scan.6,7 However, only 28% of pa-
tients in the Prospective Investigation of Pulmonary Embo-
lism Diagnosis (PIOPED) study had diagnostic lung scans
(normal, near-normal, or high-probability).8 Most patients
require further diagnostic evaluation.
Pulmonary angiography is the diagnostic reference stan-
dard, but it is invasive and associated with some morbidity
and mortality.9-11 Also, pulmonary angiography has limita-
tions, including diagnostic accuracy (particularly for small
peripheral emboli), interreader agreement, and incomplete
studies.5 An alternative approach for patients with nondiag-
nostic lung scans is noninvasive testing for deep venous
thrombosis (by either impedance plethysmography or
venous compression ultrasonography), which may be per-
formed serially if the initial test result is negative.12 This
second strategy often involves having patients return to the
hospital or clinic after dismissal for further testing, but this
has drawbacks. The problem of nondiagnostic lung scans
has led to the development of 2 new diagnostic tests: the
plasma fibrin D-dimer assay and computed tomographic
(CT) angiography.5,13
164 2004 Mayo Foundation for Medical Education and Research
Mayo Clin Proc, February 2004, Vol 79
Computed tomographic angiography has become an im-
portant tool for diagnosing acute pulmonary embolism.
Helical and electron beam CT scans of the chest are about
90% sensitive and 90% specific for the diagnosis of proxi-
mal (main, lobar, and segmental pulmonary arteries) throm-
boembolism.5 However, CT angiography is less accurate
for detecting small emboli in the subsegmental pulmonary
arteries.5 Overall, the reported sensitivity of CT angiogra-
phy for diagnosing acute pulmonary embolism has been
53% to 100%, and the reported specificity has been 75% to
100%.14-29
Continuing improvement in CT technology is leading to
better visualization of segmental and subsegmental pulmo-
nary arteries.30-33 Also, patients with suspected acute pul-
monary embolism and negative CT angiographic findings
have a good prognosis, with a very low thromboembolism
rate reported during 3 to 6 months of follow-up.20,34-38 At
our institution, CT angiography has replaced the radionu-
clide lung scan as the primary imaging procedure for diag-
nosing acute pulmonary embolism.
Plasma fibrin D-dimer is a cross-linked fibrin degrada-
tion product that can be measured in peripheral blood. It is
a marker for ongoing fibrinolysis due to activation of the
fibrinolytic system.13 The level of D-dimer can increase
about 8-fold when associated with thromboembolic dis-
ease.39 The level also increases with infection, cancer,
surgery, cardiac or renal failure, acute coronary syn-
dromes, acute nonlacunar stroke, pregnancy, and sickle
cell crises.13 In healthy persons, D-dimer levels increase
with age.40
D-dimer levels measured by the enzyme-linked im-
munosorbent assay (ELISA) technique have a high sensi-
tivity but low specificity for the diagnosis of acute pulmo-
nary embolism.41 In practice, D-dimer levels measured
with the classic microplate ELISA technique are rarely
used because they are technician-dependent, expensive,
tested in batches, and inefficient for usual clinical prac-
tice.42,43 Latex agglutination measurement of D-dimer lev-
els is used more often because it is readily available, quick
and easy to perform, and less expensive.43 During our
study, the semiquantitative latex agglutination assay was
the only D-dimer test available to clinicians at our institu-
tion for diagnosing thromboembolic disease.
Because of the low specificity of all D-dimer assays, the
primary value of this test is probably its ability to rule out
acute pulmonary embolism in patients with a low pretest
probability of the disorder.44 Wells et al45 recently studied
the combination of a simple clinical model and a Simpli-
RED whole-blood agglutination assay for the diagnosis of
acute pulmonary embolism. The combination of a low
pretest probability and a normal SimpliRED D-dimer level
in an emergency department population with a low preva-
For personal use. Mass reproduce only with permission from Mayo Clinic Proceedings.
Semiquantitative Latex Agglutination D-Dimer Assay 165
lence of pulmonary embolism (9.5%) had a negative pre-
dictive value of 0.998.46
The sensitivity of the semiquantitative latex agglutina-
tion D-dimer assay for the diagnosis of acute pulmonary
embolism is unclear. Results from previous small studies
using pulmonary angiography as the reference standard have
ranged from 73% to 100%.43,47-49 To better clarify the sensi-
tivity and specificity of the semiquantitative latex agglutina-
tion plasma fibrin D-dimer assay for diagnosing acute pul-
monary embolism, we conducted a retrospective study using
CT angiography as the diagnostic reference standard.
PATIENTS AND METHODS
Patients
According to the Radiology Research and the Labora-
tory Information Services databases at the Mayo Clinic,
1076 inpatients and outpatients had both CT angiography
for suspected acute pulmonary embolism and a semiquan-
titative latex agglutination plasma fibrin D-dimer assay
from January 1, 1998, to June 26, 2000. All studies were
performed at the Mayo Clinic in Rochester, Minn. Forty-
seven patients refused research authorization and were ex-
cluded from further analysis. This study was approved by
the Mayo Foundation Institutional Review Board.
CT Method
All patients were examined with an electron beam CT
scanner (model C-150; Imatron Inc, San Francisco, Calif)
using a method described elsewhere.38 Emboli were con-
sidered acute if they were located centrally within the
vascular lumen or if they occluded a pulmonary vessel.
Emboli were considered chronic if they were eccentric and
contiguous with the vessel wall or if there was evidence of
recanalization. A study was considered positive only if
there was a definite filling defect.14 All radiology reports
were reviewed by one of the authors (D.A.F. or P.L.E.) and
given one of the following interpretations: positive for
acute pulmonary embolism, positive for chronic pulmo-
nary embolism, negative for pulmonary embolism, or inad-
equate (or indeterminate) study. Differences of opinion
about radiology reports were resolved by consensus of the
authors.
D-Dimer Assay
Plasma fibrin D-dimer was assayed using a commercial
kit and a method recommended by the manufacturer
(semiquantitative latex agglutination assay, American
Bioproducts Co/Diagnostica Stago, Parsippany, NJ). A
positive test was defined as a D-dimer level greater than
250 ng/mL.48 Only patients with D-dimer assays performed
within 4 days before or after CT angiography were in-
cluded in the study. This requirement was based on a study
166 Semiquantitative Latex Agglutination D-Dimer Assay Mayo Clin Proc, February 2004, Vol 79

Table 1. Diagnosis of Acute Pulmonary Embolism*
CT angiography
D-dimer results
results Positive Negative Total
Positive 142 470 612
Negative 30 304 334
Total 172 774 946
*CT = computed tomographic.
that suggested the sensitivity of the assay is lower in pa-
tients when D-dimer testing is performed 4 days or more
after symptom onset.48 Thirty-eight patients were excluded
for this reason.
Statistical Analyses
To define the time frame for this retrospective study, we
assumed a 10% prevalence of acute pulmonary embolism.
With this prevalence, we calculated the maximal sample
size required to estimate the true sensitivity of the semi-
quantitative latex agglutination plasma fibrin D-dimer as-
say to within 10% with 95% confidence. The computation
indicated that a sample size of 961 patients would be re-
quired. The length of the study period was selected to
achieve the required sample size.
We summarized the ages of the participants by the mean,
SD, and range of the observed distribution. We also deter-
mined the percentage of participants of each sex. D-dimer
and CT results were compared by calculating sensitivity,
specificity, and other measures that evaluate how well the D-
dimer test compares with the diagnostic reference standard
of CT angiography. These computations were performed for
all patients and also within strata defined by the number of
days separating the D-dimer and CT tests. Statistical analy-
sis was performed with SAS software (Cary, NC).
RESULTS
From January 1, 1998, to June 26, 2000, 991 patients had
both CT angiography for suspected pulmonary embolism
and semiquantitative latex agglutination plasma fibrin D-
dimer testing within 4 days of each other and had not
refused research authorization. Twenty-seven CT studies
were inadequate or indeterminate, and 18 were positive for
only chronic pulmonary emboli; these patients were ex-
cluded from further analysis. Of the 946 patients included
in the analysis, 433 (46%) were males and 513 (54%) were
females. The mean SD age was 6318 years (range, 15-98
years). Of 946 CT studies, 172 (18%) were positive for acute
pulmonary embolism, and 774 (82%) were negative (Table
1). Of 946 D-dimer assays, 612 (65%) were positive.
The prevalence of acute pulmonary embolism in our
study population was 18%. For acute pulmonary embo-
lism, the D-dimer assay had a sensitivity of 0.83 (95%
confidence interval [CI], 0.76-0.88), a specificity of 0.39
(95% CI, 0.36-0.43), a positive likelihood ratio of 1.36
(95% CI, 1.24-1.49), a negative likelihood ratio of 0.44
(95% CI, 0.32-0.62), and a negative predictive value of
0.91 (95% CI, 0.87-0.94).
A subgroup analysis of sensitivity, specificity, and
negative predictive value stratified by the number of days
between the D-dimer assay and CT angiography is shown
in Table 2. Although the sensitivity of the D-dimer assay
for acute pulmonary embolism decreased by day 3, the CIs
were broad and suggested no significant difference for
sensitivity between days 0 and 3.
DISCUSSION
The semiquantitative latex agglutination plasma fibrin D-
dimer assay correlated with the presence of acute pulmo-
nary embolism, with a positive likelihood ratio of 1.36.
However, the assay was positive for about two thirds of the
patients and had a false-positive rate of 77%. Furthermore,
with a sensitivity of 0.83 and a negative predictive value of
0.91, this test alone was not adequate to exclude acute
pulmonary embolism.
The sensitivity of the D-dimer assay used in our study
was 0.83 for acute pulmonary embolism. This is higher than
that found by Kutinsky et al43 but lower than that reported by

Table 2. D-Dimer Diagnosis of Acute Pulmonary Embolism vs Days

Between D-Dimer Assay and CT Angiography*
Negative
Sensitivity Specificity
No. of predictive
Days patients Value 95% CI Value 95% CI value
0 439 0.82 0.72-0.89 0.43 0.38-0.48 0.91
1 373 0.84 0.74-0.92 0.33 0.28-0.39 0.90
2 72 0.82 0.48-0.98 0.48 0.35-0.61 0.94
3 50 0.75 0.19-0.99 0.37 0.23-0.52 0.94
4 12 NA NA 0.58 0.28-0.85 1.00
Total 946 0.83 0.76-0.88 0.39 0.36-0.43 0.91
*CI = confidence interval; CT = computed tomographic; NA = not applicable.

For personal use. Mass reproduce only with permission from Mayo Clinic Proceedings.
Mayo Clin Proc, February 2004, Vol 79 Semiquantitative Latex Agglutination D-Dimer Assay 167

Table 3. Comparison of Reported Sensitivity and Specificity CONCLUSIONS

Values of Semiquantitative Latex Agglutination The semiquantitative latex agglutination plasma fibrin D-
Plasma Fibrin D-Dimer Assay dimer assay had moderate sensitivity and low specificity
for Acute Pulmonary Embolism* for the diagnosis of acute pulmonary embolism. When used
No. of Reference alone, its sensitivity of 0.83 was insufficient to exclude this
Study patients Sensitivity Specificity standard serious and potentially fatal disorder. In addition, about
Pappas 20 1.00 0.77 Pulmonary two thirds of our patients had positive D-dimer assays and
et al47 angiography required further evaluation to exclude acute pulmonary
Kutinsky 98 0.73 0.57 Pulmonary
et al43 angiography embolism. The new rapid and more sensitive D-dimer as-
Heit et al48 105 0.94 0.44 Pulmonary says are promising, but we agree with Kelly et al13 that
angiography clinicians should be familiar with the performance of these
Quinn 103 0.97 0.24 Pulmonary
et al49 angiography tests in their own institutions before relying on them to help
Current 946 0.83 0.39 CT rule out acute pulmonary embolism.
study angiography
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