Journal of Clinical Laboratory Analysis 30: 216222 (2016)

Performance Evaluation of CLIA for Treponema Pallidum

Specific Antibodies Detection in Comparison with ELISA
Lixin Li, Bei Cai, Chuanmin Tao, and Lanlan Wang
Department of Laboratory Medicine, West China Hospital of Sichuan University, Chengdu, China

Objectives: In this study we aimed to evaluate the performance effects of chemiluminescence assay (CLIA) for Treponema pallidum specific antibodies detection, and to
compare T. pallidum specific antibodies detection accuracy between CLIA and ELISA
with TPPA (T. pallidum particle agglutination assay) as a confirmatory test. Methods: A total of 865 samples from suspected
syphilis patients and preoperative patients
were included, in which T. pallidum specific
antibodies were simultaneously detected by
CLIA and ELISA. Among them, 457 samples were determined by TPPA. Results: All
coefficients of variation (CVs) of ELISA in
high-, median-, and low-level samples were
more than 5% and the maximum CV was
54.39% in the low-level sample. CVs of CLIA
in different-level samples were all below 5%.
Among the three assays the Spearman correlation and Kappa coefficients were 0.771
(P 0.001) and 0.854 (P 0.001, CLIA vs.

ELISA), 0.806 (P 0.001) and 0.897 (P

0.001, ELISA vs. TPPA), 0.937 (P 0.001)
and 0.967 (P 0.001, CLIA vs. TPPA), respectively. The area under the receiver operating characteristic curve (AUC) of CLIA
was higher than that of ELISA (0.994 vs.
0.989) with TPPA as the confirmatory test.
In 18 discrepant samples the consistency
rate between CLIA and TPPA was elevated
compared with that between ELISA and
TPPA (72.22% vs. 27.78%, P = 0.008). In
gray zone, the consistency rate of CLIA with
TPPA was higher than that of ELISA with
TPPA (90.91% vs. 41.67%, P = 0.027).
Conclusions: Compared with ELISA, CLIA
is more reliable, sensitive and accurate to
detect serum T. pallidum specific antibodies. In the future it may be an alternative
test with higher sensitivity to ELISA. J. Clin.
C 2015 Wiley PeLab. Anal. 30:216222,2016. 
riodicals, Inc.

Key words: chemiluminescence assay (CLIA); Treponema pallidum particle agglutination assay (TPPA); enzyme immunoassay (EIA); Treponema pallidum specific
antibodies; syphilis

INTRODUCTION
Treponema pallidum is the pathogenic factor for syphilis,
which is a sexually transmitted disease (STD) and has the
similar clinical signs and symptoms to other infectious
diseases. Since the diagnosis of syphilis is difficult due to
its diverse clinical manifestations, the detection of etiology or serology is very important and helpful in syphilis
diagnosis. Serological tests play vital roles in the accurate
diagnosis of syphilis and are divided into nontreponemal and treponemal tests. Treponemal tests are directed
against T. pallidum proteins with high specificity; these include fluorescent treponemal antibody-absorption (FTAABS), T. pallidum hemagglutination assay (TPHA), T.
pallidum particle agglutination assay (TPPA), and enzyme
immunoassay (EIA) (1, 2). Among them FTA-ABS and
TPPA are considered as confirmatory tests, but recently

2015 Wiley Periodicals, Inc.

some investigation in Morbidity and Mortality Weekly Report (MMWR) (3) mentioned that CDC of the United
States recommended the FTA-ABS test not to be used
to confirm discordant treponemal screening results because of some shortcomings such as lower specificity and
probably lower sensitivity (4). The TPPA test is considered to be the most suitable confirmatory treponemal test according to previous published sensitivity and
The

authors contributed equally to the article.

Correspondence to: Lanlan Wang, Department of Laboratory

Medicine, West China Hospital of Sichuan University, No. 37

Guoxue Xiang, Wuhou District, Chengdu, Sichuan 610041, China.
E-mail: [email protected]
Received 6 February 2014; Accepted 24 November 2014
DOI 10.1002/jcla.21839
Published online in Wiley Online Library (wileyonlinelibrary.com).

Performance Evaluation of CLIA for T. pallidum Antibodies Detection

217

TABLE 1. Performance Characteristics of Three Different Assays

LUMIPULSE G system
Principles of assays
Analyzer

Chemiluminescent immunoassay,
CLIA (two steps)
LUMIPULSE G1200 analyzer

Reagents

R
Lumipulse
G TP-N reagent kits

Test time
Antibodies types
Coated antigen(s)
Enzymes and substrates

25 min
IgG and IgM
Recombination Tp1517 and
TpN47
ALP and AMPPD

ELISA system

Agglutination assay

Enzyme-linked immunosorbent assay,

ELISA (two steps)
Tecan freedom EVOlyzer automated
ELISA system
ELISA Diagnostic Kits for antibody
to T. pallidum
120 min
IgG and IgM
T. pallidum antigens from genetic
engineering
HRP and TMB

Gelatin particle agglutination assay

(one step)
No special analyzer
R
SERODIA
-TPPA reagents

120 min
IgG and IgM
T. pallidum (Nichols Strain) antigen
/

ALP: alkaline phosphatase; AMPPD: 3-[2-spiroadamatane]-4-methoxy-4-[3-phosphoryloxy]-phenyl-1,2-dioxetane)Dioxetane ; HRP: horse radish

peroxidase; TMB: tetramethylbenzidine

specificity data (5). However, the above-mentioned traditional treponemal tests have some inevitable limitations, such as complicated operation procedures, subjective results, time-consuming nature, and difficult automation. Therefore, development of a new analytic method
with efficient testing, easy automation, high sensitivity
and high specificity is critical for effective diagnosis of
syphilis.
With the development of methodology, chemiluminescence assay (CLIA) has come into being. CLIA can automatically and quickly detect serum T. pallidum specific
antibodies with high sensitivity and specificity for syphilis
diagnosis (68). Previous studies mainly evaluated the diagnostic efficiency of EIA in T. pallidum specific antibodies detection (9,10). Till now most studies on methodology
comparison focused on EIA with TPPA (5, 11) or CLIA
with TPPA (12), and the researches on the consistency of
performance effects for T. pallidum detection by ELISA
and CLIA were scarce. Therefore, we aimed to evaluate the
performance effects of CLIA for T. pallidum specific antibodies detection and to compare the detection accuracy
between CLIA and ELISA with TPPA as a confirmatory
test.

MATERIALS AND METHODS

Subjects
A total of 865 samples of suspected syphilis patients
and preoperative patients collected from September 2012
to February 2013 in West China Hospital of Sichuan University were included; among the patients, there were 377
females and 488 males and their mean age was 47.48 years.
All the samples were detected for T. pallidum specific antibodies by CLIA and ELISA, and 457 samples among
them were detected by TPPA as the confirmatory test.
Our study using human blood samples was performed

in accordance with the current revision of the Helsinki

Declaration.

Serum T. pallidum Specific Antibodies

Determination
Serum was separated within 3 h after drawing and
stored for 1 week at 20C. LUMIPULSE G1200 anR
G TP-N reagent kits (Fujirealyzer and Lumipulse
bio Diagnostics, Tokyo, Japan) as well as Tecan freedom EVOlyzer automated ELISA system (Tecan Group,
Mannedorf, Switzerland) and ELISA Diagnostic Kits for
Antibody to T. pallidum (InTec Products, Xiamen, China)
R
-TPPA reagents (Fujirebio Diagnostics,
and SERODIA
Inc. Tokyo, Japan) were used. All assays were carried out
according to the manufacturers standard procedures. Detailed performance characteristics of three different assays
were described in Table 1. According to the manufacturers suggestions and our clinical practical experiences, the
value of S/C.O. (the optical density ratio of sample to cutoff) between 0.8 and 1.2 and C.O.I (cut-off index) value
between 0.9 and 1.1 were considered gray zones of ELISA
and CLIA, respectively.
CLIA automatically detected serum T. pallidum specific antibodies on LUMIPULSE G1200 system. A total of 50 l serum or TP-N calibrator reacted with
250 l microparticle coated with Tp1517 and TpN47
antigens, then with 250 l ALP-conjugated Tp1517
and TpN47 antigens formed antigen-antibody-antigen
complex. With the substrate AMPPD and under 477
nm, the complex was detected by chemiluminescence
method.
ELISA detected serum T. pallidum specific antibodies
on Tecan freedom EVOlyzer automated ELISA system
with InTec ELISA kits. A total of 100 l sample, positive control, and negative control reacted with genetic
engineering antigens coated microplate, and then reacted
J. Clin. Lab. Anal.

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Li et al.

with HRP-labeled genetic engineering antigens. With the

substrate TMB and under 450 nm, the optical density was
automatically detected.
TPPA was based on the agglutination of colored gelatin
particle carriers sensitized with T. pallidum (Nichols
Strain) antigen. Serum samples were serially diluted in
sample diluent in microplate wells. Sensitized gelatin particles were added to respective wells and the contents of
the plate were mixed by hand. The mixture was incubated
for 2 h at room temperature. Serum containing specific
antibodies formed a smooth mat of agglutinated particles
in the microtitration tray. A compact button formed by
the settling of the nonagglutinated particles characterized
negative reactions.

Under the manufacturers cutoff in 865 samples, there

were 30 discrepant results between CLIA and ELISA.
And excluding the data in gray zone, in 833 samples 18
sera results were discrepant between CLIA and ELISA
(Table 3). TPPA analysis showed that in 18 discrepant
samples the consistency rate between CLIA and TPPA
was significantly higher than that between ELISA and
TPPA (72.22% (13/18) vs. 27.78% (5/18), P = 0.008).
Further analysis showed that in 18 discrepant samples the
true-positive consistency rate of CLIA (12/14, 85.71%)
was higher than that of ELISA (2/14, 14.29%; P 0.001),
and the true-negative consistency rate of CLIA (1/4, 25%)
was lower than that of ELISA (3/4, 75%; P 0.001)
compared with TPPA.

Statistics

ROC Analysis of CLIA and ELISA with TPPA as the

Confirmatory Test

All data were analyzed by statistical software SPSS

13.0. Kappa test was conducted to evaluate the consistency of qualitative results. Spearman correlation was
used to show the correlation of quantitative results. With
TPPA as the confirmatory test for T. pallidum specific antibodies detection, receiver operating characteristic (ROC)
curve analysis was made to evaluate the areas under the
ROC curve (AUCs), sensitivity and specificity of ELISA
and CLIA in T. pallidum specific antibodies detection.
Chi-square test or Fishers exact test was performed
to analyze the qualitative data or categorical variable
comparison. P-value <0.05 was considered statistically
significant.

RESULTS
Imprecision Analysis of ELISA and CLIA for
Detecting T. pallidum Specific Antibodies
High-, median-, and low-concentration samples were
selected to be continuously detected 20 times by ELISA
and CLIA. The detection showed that all coefficients of
variation (CVs) of ELISA in high-, median-, and low-level
samples were more than 5% and the maximum CV was
54.39% in the low-level sample. CVs of CLIA in differentlevel samples were all below 5% and less than CVs of
ELISA in all the samples (Table 2).

AUC, specificity and sensitivity of CLIA and ELISA

were calculated with TPPA as the confirmatory test. It
showed that AUC of CLIA (0.994, P 0.001) was higher
than that of ELISA (0.989, P 0.001; Fig. 1d). Under the
manufactures cutoff, the sensitivity of CLIA was higher
than that of ELISA (94.07% vs. 82.96%) and the specificity of CLIA was similar to that of ELISA (99.07% vs.
99.38%). In quantitative data, Spearman correlation coefficient between CLIA and TPPA (rs = 0.937, P 0.001)
was higher than that between ELISA and TPPA (rs =
0.806, P 0.001; Fig. 1b and 1c)
When excluding the gray-zone data, the sensitivity and
specificity of CLIA were 91.11% and 98.45%, and those of
ELISA were 87.40% and 99.37%. The consistency analysis of qualitative data showed Kappa coefficient between
CLIA and TPPA was higher than that between ELISA
and TPPA (0.967 (P 0.001) vs. 0.897 (P 0.001), Table 4). The false-positive rates of CLIA and ELISA were
similar (0.94% (3/320) vs. 0.63% (2/318)), and the falsenegative rate of CLIA was lower than that of ELISA
(2.38% (3/126) vs. 12.60% (16/127), P = 0.002).

TABLE 2. Imprecision Analysis of ELISA and CLIA for Detecting T. pallidum Specific Antibodies

Consistency Analysis of CLIA and ELISA

in Quantitative and Qualitative Results

CV (%)

In quantitative data or numerical variable, consistency

analysis showed that Spearman correlation coefficient between CLIA and ELISA was 0.771 (P 0.001, Fig. 1a)
and when data were described as qualitative or categorical
variable Kappa coefficient was 0.854 (P 0.001, Table 3).

a Mean

J. Clin. Lab. Anal.

ELISA
CLIA

Low
concentrationa

Median
concentrationb

High
concentrationc

54.39
4.42

10.63
1.43

6.79
2.09

low concentration: CLIAC.O.I = 0.1, ELISAS/C.O. =

0.004.
b Mean median concentration: CLIAC.O.I = 11.7, ELISAS/
C.O. = 7.44.
c Mean high concentration: CLIAC.O.I = 73.76, ELISAS/
C.O. = 17.01.

Performance Evaluation of CLIA for T. pallidum Antibodies Detection

219

Fig. 1. Quantitative analysis of serum T. pallidum specific antibodies detected by ELISA and CLIA . (a) Correlation of serum T. pallidum specific
antibodies levels between ELISA and CLIA. (b and c) Correlation of serum T. pallidum specific antibodies levels between CLIA or ELISA and
TPPA. (d) ROC analysis of CLIA and ELISA for serum T. pallidum specific antibodies detection with TPPA as the confirmatory test.

Accuracy Analysis in Gray-Zone Data of ELISA

and CLIA
It was hard to define gray-zone data as true positive or
true negative. Here TPPA was as the confirmatory test to
detect serum T. pallidum specific antibodies. Compared
with TPPA, the consistency rate of CLIA in gray-zone
data was significantly higher than that of ELISA (90.91%
(10/11) vs. 41.67% (5/12), P = 0.027); true-positive rate in
gray zone of CLIA also was strikingly higher than that of
ELISA (81.82% (9/11) vs. 8.33% (1/12), P = 0.001) and
true-negative rate of CLIA was lower than that of ELISA
(9.09% (1/11) vs. 33.33% (4/12), P = 0.317; Table 4).
Further analysis showed that 54.50% data in gray zone of
CLIA were in TPPA low titer level (1:80), and 50% data
in gray zone of ELISA were in TPPA median (1:160) and
high titer levels (1:320, Table 5).

TABLE 3. Kappa Test Analysis Between CLIA and ELISA

CLIA
Negative Gray zone Positive
ELISA

Kappa coefficient

Negative
Gray zone
Positive

649
6
10
4
3
5
0.854 (P 0.001)

15
7
166

DISCUSSION
Serological tests, especially treponemal tests, play an
important role in syphilis diagnosis. Reverse sequence
screening test for T. pallidum specific antibodies, in which
sera are tested first by a treponemal EIA, is widely used
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Li et al.

TABLE 4. Comparison of ELISA and CLIA with TPPA Using Serum Specimens
TPPA results (N)

Assays and results

Negative

CLIA
Negative
Positive
Equivocal
Low valuea
High valueb
ELISA

317
3
2
1
1

Negative
Positive
Equivocal
Low valuea
High valueb

316
2
4
4
0

a Value
b Value

%Sensitivity
(95% CI)

%Specificity
(95% CI)

%agreement
(95% CI)

Kappa values
(P-value)

91.11
(88.3393.54)

98.45
(97.1299.38)

96.28
(94.3597.82)

0.967
(P 0.001)

87.40
(84.2090.28)

99.37
(98.4499.89)

93.44
(90.9995.52)

0.897
(P 0.001)

Positive

3
123
9
0
9

16
111
8
7
1

was lower than the manufacturers cutoff of CLIA or ELISA.

was higher than the manufacturers cutoff of CLIA or ELISA.

TABLE 5. ELISA and CLIA Gray Zone Data Analysis Compared with TPPA
TPPA
Positive

ELISA gray zone

CLIA gray zone

Negative

1:80

1:160

1:320

4(33.30%)
2(18.20%)

2(16.70%)
6(54.50%)

3(25.00%)
2(18.20%)

3(25.00%)
1(9.10%)

for syphilis serodiagnosis to reduce the time and labor required for syphilis screening. And EIA, especially
ELISA and CLIA, will gradually become the critical
screening treponemal test. ELISA, an important assay of
EIAs, is considered as a traditional assay to detect serum
T. pallidum specific antibodies, and especially based on
its high sensitivity and specificity, it has been widely used
since 1980s (13). CLIA, a newly developed method, can
allow for rapid detection of T. pallidum specific antibodies
on random-access analyzers with higher precision, sensitivity and specificity (6, 7). And TPPA, as the confirmatory test, can ensure its sensitivity and specificity for diagnosing syphilis infection by using T. pallidum (Nichols
Strain) as antigen. Table 1 presented the characteristics of
ELISA, TPPA, and CLIA, which indicated that CLIA was
less time consuming and easy to handle compared with
ELISA and TPPA. It also indicated that different assays
applied different antigens and analysis systems to detect
serum T. pallidum specific antibodies. CLIA and ELISA
just used some T. pallidum antigen peptides, while in TPPA
coated-antigen was the Nichols strain T. pallidum. As it
J. Clin. Lab. Anal.

was known that the difference of coated antigen could

influence sensitivity and specificity of assays. Here we expected to make the performance evaluation of CLIA in
detecting T. pallidum specific antibodies compared with
ELISA and TPPA.
Because treponemal tests were used to diagnose syphilis,
the test stability was important. Table 2 demonstrated
that CLIA was a more stable assay in detecting different
T. pallidum specific antibodies levels (all CVs (%) < 5%),
and ELISA results were diverse, especially in low-level
detection (which was close to background level and easily
influenced by many factors), and CVs of ELISA in median
or high level were still higher than 5%.
Some reports showed that in the population with
low prevalence of syphilis there was higher discordant
percentage and false-positive percentage among different tests (3). So in our subjects the suspected syphilis
patients and preoperative patients were included to
avoid the different prevalence of syphilis in different
population.
CLIA and ELISA were both EIAs, and ELISA was
the traditional test. Here we made a consistency analysis
between ELISA and CLIA in a prospective study with
865 sera. Because some data of CLIA were more than its
upper limit, scatter figure was limited to show the correlation between CLIA and ELISA in abnormal distributed
data, and Spearman correlation analysis would be a more
proper method to evaluate their correlation. Here Kappa
test (Kappa = 0.854) and Spearman correlation analysis
(rs = 0.771) both indicated that there was a good consistency between CLIA and ELISA.
Further, we used TPPA as the confirmatory test to assess CLIA and ELISA performance characteristics. In

Performance Evaluation of CLIA for T. pallidum Antibodies Detection

quantitative and qualitative analysis, CLIA showed

higher consistency with TPPA compared with ELISA;
especially as a serodiagnosis test CLIA had low falsenegative rate (2.38%) and false-positive rate (0.94%) to
guarantee the lower misdiagnosis and missed diagnosis
rates. Figure 1d indicated that with TPPA as the confirmatory test both CLIA and ELISA had good diagnosis
efficiency (all the AUCs 0.95), and CLIA was better.
Compared with other studies (5, 6, 1417), the sensitivity
and specificity of CLIA and ELISA in our study were close
or similar to otherswhich indicated that the difference
of reference/confirmatory tests may not be the critical factor to influence the sensitivity and specificity of evaluated
assays. Wellinghausen N et al. and we both appraised diagnostic efficiency of CLIA with different confirmatory tests
(FTA-ABS in Wellinghausen N et al.s study and TPPA
in our study). We have drawn a common conclusion that
CLIA was a good screening test for syphilis diagnosis with
good sensitivity and specificity (more than 90%). Here we
speculated that the differences of coated antigens and analyzers or detection systems between ELISA and CLIA
could be important factors to influence the sensitivity of
ELISA. Some study demonstrated that CLIA might have
a role either as a diagnostic screening test or as a confirmatory test following a nontreponemal screening test
(6). However, we thought CLIA may be more appropriate
for a screening test, not a perfect confirmatory test for
syphilis diagnosis due to the coated nonintact T. pallidum
antigen in CLIA. The nonintact T. pallidum antigen theoretically could cause false-positive results and influence
the specificity and sensitivity of CLIA, which is shown in
Table 4.
Gray-zone definition and interpretation were always
problems for diagnostic test. Here Table 4 showed that
CLIA had a higher accuracy and sensitivity with TPPA in
all data analysis or excluding gray-zone data analysis than
ELISA. And discrepant results analysis demonstrated
that CLIA had higher diagnostic accuracy rate (72.22%)
and positive consistency rate (85.71%) with TPPA than
ELISA. Table 5 shows that CLIA and ELISA gray-zone
data mainly distributed in low titer of TPPA and high titer
of TPPA, respectively. Our study indicated that ELISA
had lower sensitivity and higher false-negative rate as a
screening test compared with CLIA. Meanwhile, Table 4
shows that excluding the gray-zone data the sensitivity of
ELISA could increase, and the sensitivity and specificity
of CLIA were not influenced, which indicated that the
data in ELISA gray zone should be paid more attention,
and samples in ELISA gray zone had better be repeated
with other treponemal test.
CONCLUSIONS
Compared with ELISA, CLIA is more reliable, sensitive and accurate to detect serum T. pallidum specific

221

antibodies. In the future it may be an alternative test with

higher sensitivity to ELISA as a screening test for syphilis
diagnosis.
ACKNOWLEDGMENTS
We thank Fujirebio Diagnostics company for generous
donation of their assays and Mr. Qingfei Zeng for his hard
work on data collection.
DISCLOSURE
The authors have declared no conflicts of interest.
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