scholarly journals Comparison of Syphilis Rapid Diagnostic Test to Rapid Plasma Reagin, Treponema pallidum Haemagglutination Assay and Fluorescent Treponemal Antibody-Absorption for Syphilis and Yaws Diagnostics

2020 ◽  
Vol 12 (2) ◽  
pp. 136-42
Author(s):  
Astuti Giantini ◽  
Dewi Wulandari ◽  
Siskawati Suparmin
Keyword(s):  
General Hospital ◽  
Diagnostic Test ◽  
Rapid Diagnostic Test ◽  
Clinical Laboratory ◽  
Treponema Pallidum ◽  
Rapid Plasma Reagin ◽  
Serum Samples ◽  
Haemagglutination Assay ◽  
Antibody Absorption ◽  
Test Serum

BACKGROUND: Syphilis and yaws are the treponemal infections which have become serious public health problems, and both are serologically indistinguishable. Developed serological tests for syphilis may also be used to diagnose yaws. In remote area, test modality with minimal requirements were needed. This study investigated the diagnostic value of syphilis rapid diagnostic test (RDT) in diagnosing syphilis and yaws.METHODS: For syphilis diagnostic test, serum samples were obtained from patients of outpatient clinic in Dr. Cipto Mangunkusumo National Central General Hospital who were sent for rapid plasma reagin (RPR) and Treponema pallidum haemagglutination assay (TPHA) to clinical laboratory of the hospital. The serum samples were collected and stored at -80°C until the day of testing for syphilis RDT and fluorescent treponemal antibody-absorption (FTA-Abs). For yaws diagnostic test, serum samples were obtained as a part of surveillance study of yaws among children 1-15 years old in West Halmahera. Venous blood samples were used for syphilis RDT and the sera were separated and were sent to Dr. Cipto Mangunkusumo National Central General Hospital for RPR, TPHA, and FTA-Abs tests.RESULTS: For syphilis diagnostic test, among 156 samples, 39 samples were positive with syphilis RDT. The sensitivity of syphilis RDT was similar to RPR and TPHA (100.0%), the specificity was same as TPHA (77.5%), but lower than RPR (84.8%) when compared to FTA-Abs IgM. The sensitivity of syphilis RDT was 62.5% and the specificity was 96.0% when compare to FTA-Abs IgG. For yaws diagnostic test, among 176 samples, 13 samples were positive with syphilis RDT. By using FTA-Abs IgM as gold standard for diagnosing yaws, the RDT have similar sensitivity (50.0%) with RPR and TPHA and syphilis RDT have similar specificity to TPHA (93.1%). If compared to FTA-Abs IgG, the sensitivity of syphilis RDT was 40.0% and the specificity was 98.0%.CONCLUSION: Syphilis RDT gives similar results with TPHA in syphilis and yaws cases. It may be used as a first line screening test latent or untreated syphilis and yaws because of good sensitivity. For yaws diagnosis Syphilis RDT, RPR, and TPHA have low sensitivity, however all those tests have an excellent agreement.KEYWORDS: FTA-Abs, rapid diagnostic test, syphilis, yaws 

scholarly journals Investigation of the rapid immunochromatographic test performance in the diagnosis of syphilis; comparison of four serological methods

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Huseyin Agah Terzi ◽  
Ozlem Aydemir ◽  
Engin Karakece ◽  
Huseyin Hatipoglu ◽  
Mehmet Olmez ◽  
...  
Keyword(s):  
Test Performance ◽  
Gold Standard ◽  
Treponema Pallidum ◽  
Rapid Test ◽  
Immunochromatographic Test ◽  
Rapid Plasma Reagin ◽  
Serum Samples ◽  
Hemagglutination Assay ◽  
Predictive Values ◽  
Sensitivity Specificity

AbstractObjectivesTo test the performance of the newly available rapid test for syphilis, we compared it with Treponema pallidum hemagglutination assay (TPHA). Additionally, we investigated the performance of rapid plasma reagin (RPR) and chemiluminescence microparticle immunoassays (CMIA) at our laboratory using TPHA as a gold standard.MethodsThe serum samples of 595 patients with the pre-diagnosis of syphilis were studied by four serological methods. The sensitivity, specificity, and predictive values of RPR, CMIA, and syphilis rapid test were assessed by utilizing TPHA as a gold standard for the diagnosis of syphilis.ResultsOf the patients, 6.2% (37/595) had positive RPR, 5.5% (33/595) had positive CMIA, 5.5% (33/595) had a positive rapid immunochromatographic method and 5% (30/595) had positive TPHA. When TPHA results were taken as the reference, the sensitivity of the rapid test for syphilis was 100%, the specificity was 99.5%, PPV was 90.9%, and NPV was 100.0%.ConclusionsIt was observed that the rapid test for syphilis used in the study was quite successful, its cost was appropriate, and the test was very fast and easy to apply. At the same time, the agreement between syphilis rapid test and TPHA was found to be excellent.

scholarly journals Performance Evaluation of Commercial Dengue Diagnostic Tests for Early Detection of Dengue in Clinical Samples

2017 ◽  
Vol 2017 ◽  
pp. 1-4 ◽  
Author(s):  
Tuan Nur Akmalina Mat Jusoh ◽  
Rafidah Hanim Shueb
Keyword(s):  
Dengue Virus ◽  
Real Time ◽  
Diagnostic Test ◽  
Rapid Diagnostic Test ◽  
Dengue Infection ◽  
Clinical Samples ◽  
Enzyme Linked Immunosorbent Assay ◽  
Rt Pcr ◽  
Serum Samples ◽  
Kappa Agreement

The shattering rise in dengue virus infections globally has created a need for an accurate and validated rapid diagnostic test for this virus. Rapid diagnostic test (RDT) and reverse transcription-polymerase chain reaction (RT-PCR) diagnostic detection are useful tools for diagnosis of early dengue infection. We prospectively evaluated the diagnostic performance of nonstructural 1 (NS1) RDT and real-time RT-PCR diagnostic kits in 86 patient serum samples. Thirty-six samples were positive for dengue NS1 antigen while the remaining 50 were negative when tested with enzyme-linked immunosorbent assay (ELISA). Commercially available RDTs for NS1 detection, RTK ProDetect™, and SD Bioline showed high sensitivity of 94% and 89%, respectively, compared with ELISA. GenoAmp® Trioplex Real-Time RT-PCR and RealStar® Dengue RT-PCR tests presented a comparable kappa agreement with 0.722. The result obtained from GenoAmp® Real-Time RT-PCR Dengue test showed that 14 samples harbored dengue virus type 1 (DENV-1), 8 samples harbored DENV-2, 2 samples harbored DENV-3, and 1 sample harbored DENV-4. 1 sample had a double infection with DENV-1 and DENV-2. The NS1 RDTs and real-time RT-PCR tests were found to be a useful diagnostic for early and rapid diagnosis of acute dengue and an excellent surveillance tool in our battle against dengue.

scholarly journals Sensitivity and specificity of a rapid test for assessment of exposure to SARS-CoV-2 in a community-based setting in Brazil

2020 ◽  
Author(s):  
Lucia Campos Pellanda ◽  
Eliana Márcia da Ros Wendland ◽  
Alan John Alexander McBride ◽  
Luciana Tovo-Rodrigues ◽  
Marcos Roberto Alves Ferreira ◽  
...  
Keyword(s):  
Diagnostic Test ◽  
Rapid Diagnostic Test ◽  
Sensitivity And Specificity ◽  
Rapid Test ◽  
Laboratory Diagnosis ◽  
Epidemiological Studies ◽  
Population Based ◽  
Serum Samples ◽  
Kappa Score ◽  
Qrt Pcr

AbstractBackgroundWhile the recommended laboratory diagnosis of COVID-19 is a molecular based assay, population-based studies to determine the prevalence of COVID-19 usually use serological assays.ObjectiveTo evaluate the sensitivity and specificity of a rapid diagnostic test for COVID-19 compared to quantitative reverse transcription polymerase chain reaction (qRT-PCR).MethodsWe evaluated the sensitivity using a panel of finger prick blood samples from participants >18 years of age that had been tested for COVID-19 by qRT-PCR. For assessing specificity, we used serum samples from the 1982 Pelotas (Brazil) Birth Cohort participants collected in 2012 with no exposure to SARS-CoV-2.ResultsThe sensitivity of the test was 77.1% (95% CI 66.6 - 85.6), based upon 83 subjects who had tested positive for qRT-PCR at least 10 days before the rapid diagnostic test (RDT). Based upon 100 sera samples, specificity was 98.0% (95% CI 92.9 - 99.8). There was substantial agreement (Kappa score 0.76) between the qRT-PCR results and the RDT.InterpretationThe validation results are well in line with previous assessments of the test, and confirm that it is sufficiently precise for epidemiological studies aimed at monitoring levels and trends of the COVID-19 pandemic.

scholarly journals Evaluation of the Bio-Rad BioPlex 2200 Syphilis Multiplex Flow Immunoassay for the Detection of IgM- and IgG-Class Antitreponemal Antibodies

2010 ◽  
Vol 17 (6) ◽  
pp. 966-968 ◽  
Author(s):  
E. Gomez ◽  
D. J. Jespersen ◽  
J. A. Harring ◽  
M. J. Binnicker
Keyword(s):  
Specific Antibody ◽  
Treponema Pallidum ◽  
Random Access ◽  
Laboratory Diagnosis ◽  
Multiplex Assay ◽  
Rapid Plasma Reagin ◽  
Antibody Testing ◽  
Serologic Response ◽  
Antibody Absorption ◽  
Particle Agglutination

ABSTRACT The laboratory diagnosis of syphilis is based primarily upon serologic findings. Historically, serologic testing for syphilis has relied on assays such as rapid plasma reagin, fluorescent treponemal antibody absorption, Treponema pallidum particle agglutination (TP-PA), and more recently, enzyme immunoassay (EIA). In this study, we evaluated the performance of a novel multiplex flow immunoassay (BioPlex 2200 Syphilis; Bio-Rad Laboratories, Hercules, CA) for the detection of antitreponemal IgG- and IgM-class antibodies. Serum specimens (n = 1,008) submitted for routine treponema-specific antibody testing by syphilis IgM and IgG EIA (Trep-Chek; Phoenix-Biotech, Mississauga, Ontario, Canada) were also analyzed by the BioPlex Syphilis multiplex assay. Specimens showing discordant results were repeat tested, with further discrepancies being arbitrated by TP-PA. Compared directly to the results of EIA, the BioPlex IgG assay demonstrated 98.7% (77/78) sensitivity and 99.4% (916/930) specificity. Compared to the Trep-Chek IgM EIA, the BioPlex IgM assay showed 80% (4/5) sensitivity and 97.9% (652/666) specificity. These results indicate that the BioPlex Syphilis multiplex assay shows similar serological agreement with EIA while allowing for a fully automated random-access platform that provides faster (1.7 h for 100 samples versus 4.5 h by EIA) and higher-throughput (800 samples per 9 h versus 200 samples by EIA) analysis of the syphilis serologic response.

scholarly journals Evaluation of Two Immunoblot Assays and a Western Blot Assay for the Detection of Antisyphilis Immunoglobulin G Antibodies

2009 ◽  
Vol 17 (1) ◽  
pp. 183-184 ◽  
Author(s):  
Ryan J. Welch ◽  
Christine M. Litwin
Keyword(s):  
Western Blot ◽  
Immunoglobulin G ◽  
Treponema Pallidum ◽  
Absorption Test ◽  
Rapid Plasma Reagin ◽  
Western Blot Assay ◽  
Agglutination Assay ◽  
Antibody Absorption ◽  
Particle Agglutination

ABSTRACT In the present study, two immunoglobulin G (IgG) immunoblot assays and one IgG Western blot assay were compared to the rapid plasma reagin test (RPR), the fluorescent treponemal antibody absorption test (FTA-ABS), and the Treponema pallidum particle agglutination assay (TP-PA). The agreement levels of the Viramed, Virotech, and MarDx assays were 97.0%, 96.4%, and 99.4%, and the agreements of samples inconclusive by FTA-ABS and resolved by TP-PA were 91.7%, 83.3%, and 69.4%, respectively.

scholarly journals The distribution of lagomorph syphilis caused by Treponema paraluisleporidarum in Europe

2021 ◽  
Vol 67 (5) ◽  
Author(s):  
Linda Hisgen ◽  
Lena Abel ◽  
Luisa Hallmaier-Wacker ◽  
Simone Lüert ◽  
Antonio Lavazza ◽  
...  
Keyword(s):  
Oryctolagus Cuniculus ◽  
Treponema Pallidum ◽  
Cross Reactivity ◽  
Lepus Europaeus ◽  
Brown Hare ◽  
Serum Samples ◽  
European Brown Hare ◽  
Antibody Absorption ◽  
European Rabbits ◽  
Domestic Rabbits

AbstractTreponema paraluisleporidarum infects both rabbits (ecovar Cuniculus) and hares (ecovar Lepus). While the occurrence of the bacterium has previously been reported for European brown hares (Lepus europaeus) and domestic rabbits (Oryctolagus cuniculus f. domestica), there are no data available that report infection in the European context. We tested a total of 1,995 serum samples and 287 genital swabs from opportunistically sampled European brown hares (Lepus europaeus; n = 2135), Mountain hares (Lepus timidus; n = 4), European rabbits (Oryctolagus cuniculus; n = 138), and pet rabbits (O. cuniculus f. domestica; n = 5). The samples originated from eight European countries. In case only serum was available, we tested the samples for the presence of anti-treponemal antibodies. For this, we utilized the Treponema pallidum-particle agglutination test (TP-PA), which is suited for the use in lagomorphs due to the antigenic cross-reactivity of anti-T. pallidum and anti-T. paraluisleporidarum antibodies. In addition, the results of 380 sera were confirmed using the fluorescent-Treponema antibody absorption test (FTA-ABS). In all cases where swab samples were available, DNA was extracted and tested using quantitative PCR to test for the presence of the lagomorph syphilis-bacterium. We were able to detect antibodies in 825 of 1,995 lagomorph sera (41.4%; brown hare: 825/1,868; rabbit: 0/127) and obtained positive qPCR results from 182 of 287 swab samples (63.4%; European brown hare: 167/267; mountain hare: 4/4; rabbit: 11/16). While all rabbit sera (n = 127) tested negative for anti-treponemal antibodies, the presence of the bacterium was confirmed in eight wild (n = 8/11) and three domestic rabbits (n = 3/5) from Germany using qPCR.

Significance of laboratory findings for the diagnosis of neurosyphilis

2000 ◽  
Vol 11 (4) ◽  
pp. 224-234 ◽  
Author(s):  
A F Luger ◽  
B L Schmidt ◽  
M Kaulich
Keyword(s):  
Venereal Disease ◽  
Treponema Pallidum ◽  
Lower Sensitivity ◽  
Diagnostic Significance ◽  
Laboratory Findings ◽  
Haemagglutination Assay ◽  
Specificity And Sensitivity ◽  
Antibody Absorption ◽  
Cdc Guidelines ◽  
History Of

Our objective is to assess the specificity and sensitivity, and thus elaborate the relevance, of different laboratory findings for the diagnosis of neurosyphilis. One hundred and fourteen HIV-negative pairs of serum and cerebrospinal fluid (CSF) samples were examined by the Venereal Disease Research Laboratory (VDRL) test, a fluorescent treponemal antibody-absorption (FTA-ABS) test, micro-haemagglutination assay with Treponema pallidum antigen (MHA-TP) test (serum) and Treponema pallidum haemagglutination assay (TPHA) test (CSF); further, albumin, total protein, and total IgG were determined and, in the CSF, cell count was performed. The donors were 60 patients with active neurosyphilis and 54 healthy persons with a former history of syphilis and with persisting positive results in the T. pallidum haemagglutination tests (serum: MHA-TP, CSF: TPHA), who supplied specimens for control. Albumin quotient, IgG index, TPHA index, modified TPHA index, Intrathecally produced T. pallidum Antigen (ITpA) index, its 2 modifications and, in 12 samples, the adenovirus group antibody (AVGA)/TPHA index were ascertained. The specificity and sensitivity of the TPHA index were 100% and 98.3%, of the modified TPHA index 50.0% and 96.7%, of the ITpA index 42.6% and 90.0%, of the modified ITpA indices 51.8% and 68.3% (first modification) and 53.7% and 63.3% (second modification). The AVGA/TPHA index yielded a specificity of 91.7% (11/ 12). The CSF VDRL test was positive in 55/60 (91.7%) of samples from patients with neurosyphilis and in none of the controls (0/54). A CSF-TPHA titre greater than 1:320 was observed in 59/60 (98.3%) of the neurosyphilis specimens and in none of the controls (0/54). A TPHA index above an outcome of 70, a positive CSF-TPHA test at a titre greater than 1:320 and, with lower sensitivity, the criteria of the Centers for Disease Control (CDC) guidelines yield the most reliable results for laboratory support to a diagnosis of neurosyphilis. The modified TPHA index, the ITpA index, and its 2 modifications produce results of minor sensitivity and poor specificity. Observations on the AVGA/THPA index are too limited yet for judgement. The diagnostic significance of a CSF-TPHA titre above 320 needs further confirmation on a greater number of observations made by different laboratories.

scholarly journals Comparison of Manual and Fully Automated AIX1000 Rapid Plasma Reagin Assays for Laboratory Diagnosis of Syphilis

2018 ◽  
Vol 56 (8) ◽  
Author(s):  
Alan M. Sanfilippo ◽  
Kristie Freeman ◽  
John L. Schmitz
Keyword(s):  
Sensitivity And Specificity ◽  
Clinical Laboratory ◽  
Laboratory Diagnosis ◽  
Rapid Plasma Reagin ◽  
Serum Samples ◽  
Enhanced Sensitivity ◽  
System A ◽  
Syphilis Testing ◽  
Testing Algorithm ◽  
The University

ABSTRACTThe analytical performance of the AIX1000 system, a fully automated and recently FDA-cleared rapid plasma reagin (RPR) system, was evaluated by comparison to a manual RPR test in a traditional syphilis testing algorithm. A total of 1,028 consecutive serum samples submitted for syphilis testing to the University of North Carolina Hospitals Clinical Immunology Laboratory were tested per each manufacturer's instructions. Among those samples, 996 were nonreactive and 20 were reactive using both the ASI RPR card system and the AIX1000 system. Of the 12 discrepant specimens, 11 were AIX1000 reactive and ASI card nonreactive whereas 1 specimen was ASI card reactive and AIX1000 nonreactive. The sensitivity and specificity of the manual ASI card were 76.0% and 99.8%, respectively, while the sensitivity and specificity of the AIX100 were 100.0% and 99.4%, respectively (sensitivityP= 0.03). Among the 20 concordant reactive specimens, 68.4% of the titers agreed within ±1 dilution between methods. Reproducibility testing of the AIX1000 system demonstrated qualitative and semiquantitative (within ±1 dilution) agreement between specimens tested on different days of 96.0% and 76.0%, respectively, and 100.0% agreement between replicates within the same run. One of 24 samples analyzed under other disease conditions was reactive on both the AIX1000 system and the ASI card. Overall, the fully automated AIX1000 system demonstrated significantly enhanced sensitivity and specificity similar to that of the manual ASI RPR card test, making the AIX1000 system suitable for the laboratory diagnosis of syphilis in a clinical laboratory setting.

scholarly journals Higher seroprevalence of Entamoeba histolytica than that of HIV-1 at a voluntary counselling and testing centre in Tokyo

2019 ◽  
Author(s):  
Yasuaki Yanagawa ◽  
Mami Nagashima ◽  
Hiroyuki Gatanaga ◽  
Yoshimi Kikuchi ◽  
Shinichi Oka ◽  
...  
Keyword(s):  
Public Health ◽  
Entamoeba Histolytica ◽  
Treponema Pallidum ◽  
Rapid Plasma Reagin ◽  
Serum Samples ◽  
Transmitted Infection ◽  
Sexually Transmitted ◽  
Voluntary Counselling ◽  
Voluntary Counselling And Testing ◽  
Hiv 1

AbstractBackgroundAmebiasis, which is caused by Entamoeba histolytica, is a re-emerging public health issue owing to sexually transmitted infection (STI) in Japan. However, epidemiological data are quite limited.MethodologyTo reveal the relative prevalence of sexually transmitted E. histolytica infection to other STIs, we conducted a cross-sectional study at a voluntary counselling and testing (VCT) centre in Tokyo. Seroprevalence of E. histolytica was assessed according to positivity with an enzyme-linked immunosorbent assay for E. histolytica-specific IgG in serum samples collected from anonymous VCT clients.Principal FindingsAmong 2,083 samples, seropositivity for E. histolytica was 2.64%, which was higher than that for HIV-1 (0.34%, p < 0.001) and comparable to that for syphilis (rapid plasma reagin (RPR) 2.11%, p = 0.31). Positivity for Chlamydia trachomatis in urine by transcription-mediated amplification (TMA) was 4.59%. Seropositivity for E. histolytica was high among RPR-or Treponema pallidum hemagglutination (TPHA)-positive individuals and it was not different between clients with and without other STIs. Both seropositivity of E. histolytica and RPR were high among male clients. The seropositive rate for anti-E. histolytica antibody was positively correlated with age. TMA positivity for urine C. trachomatis was high among female clients and negatively correlated with age. Regression analysis identified that male sex, older age, and TPHA-positive results are independent risk factors of E. histolytica seropositivity.ConclusionsSeroprevalence of E. histolytica was 7.9 times higher than that of HIV-1 at a VCT centre in Tokyo, with a tendency to be higher among people at risk for syphilis infection.Author summaryAmebiasis caused by Entamoeba histolytica is an increasingly prevalent sexually transmitted infection (STI) in Japan; however, relative to other STIs, the prevalence of E. histolytica has not been fully assessed. We investigated the seropositivity of E. histolytica using serum samples from 2,083 clients of a voluntary counselling and testing centre in Tokyo. E. histolytica seroprevalence (2.64%) was 7.9 times higher than that of HIV-1 (0.31%) and the same as that of syphilis (rapid plasma reagin: 2.11%). Logistic regression analysis showed that E. histolytica seroprevalence tended to be higher among individuals who were male, older, and positive in Treponema pallidum hemagglutination. These results strongly suggest that public health interventions should be considered to control sexual transmission of E. histolytica infection, which is currently neglected in Japan.

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