Performance of the OSOM Trichomonas Rapid Test for diagnosis of Trichomonas vaginalis infection among women in Mysore, India

Sexual Health ◽  
2013 ◽  
Vol 10 (4) ◽  
pp. 320 ◽  
Author(s):  
Purnima Madhivanan ◽  
Tan Li ◽  
Stephanie Trammell ◽  
Chirayu Desai ◽  
Vijaya Srinivas ◽  
...  

Background Trichomonas vaginalis is the world’s most common treatable sexually transmissible infection. Currently, wet mount microscopy and syndromic management based on vaginal discharge are the most widely used methods for diagnosing and treating trichomoniasis in resource-constrained settings. Wet mount microscopy requires equipment and trained technicians, who are in short supply. We examined the diagnostic accuracy of the OSOM Trichomonas Rapid Test for detecting T. vaginalis vaginal infection among women in Mysore, India. Methods: During July 2009–August 2010, 450 sexually active women over 18 years seeking care at an urban reproductive health clinic were enrolled in the study. Clinician-collected vaginal swabs were evaluated for trichomonads using wet mount microscopy, InPouch culture and the OSOM test. Results: Of the 418 samples included in the analyses, culture detected 68 (16.3%) positive samples, wet mount microscopy detected 56 of the culture-positive samples and four false positive samples. The OSOM test detected 60 of the culture-positive samples plus two false positive cases. Using the composite reference standard (CRS), defined as wet mount- or culture-positive, the sensitivities of wet mount, the OSOM test and culture were 83.3%, 86.1% and 94.4%, respectively. The positive and negative predictive values of the OSOM test were 100% and 97.1% respectively. The Cohen’s kappa agreement between the OSOM test and the CRS was excellent (κ = 0.94). Conclusion: The OSOM test has high sensitivity, excellent specificity, and excellent positive and negative predictive value compared to a CRS. This simple test can improve screening and diagnosis of T. vaginalis infection in resource-constrained settings where microscopy and culture are unavailable.

1994 ◽  
Vol 2 (1) ◽  
pp. 16-19 ◽  
Author(s):  
J. Jeremias ◽  
D. Draper ◽  
M. Ziegert ◽  
W. Jones ◽  
S. Inglis ◽  
...  

Objective:Trichomonas vaginalisvaginal infections are often both asymptomatic and difficult to detect by current methods. We evaluated the ability of a newly developed polymerase chain reaction (PCR) assay to identifyT. vaginalisin vaginal samples from pregnant and non-pregnant women.Methods:In the 1st study, we compared the prevalence ofT. vaginalisdetection by PCR and culture using Diamond's medium in 52 women with symptoms of vaginal infection. In the 2nd study,T. vaginaliswas detected using PCR and wet mount microscopy in 131 asymptomatic pregnant women.Results:Among the women with symptoms of vaginitis, 7 (13.5%) were PCR-positive forT. vaginalis. Six of the PCR-positive women, but none of the PCR-negative women, were culture-positive for this organism. All but 1 of the women with candidal vaginitis or bacterial vaginosis were PCR-negative for T.vaginalis. Among the asymptomatic pregnant women, all of whom were negative forT. vaginalisby wet mount, l0 (7.6%) were PCR-positive forT. vaginalis.Conclusions:PCR offers a rapid and sensitive alternative to culture and microscopy for the detection ofT. vaginalisvaginal infections in both symptomatic and asymptomatic women.


2020 ◽  
Vol 31 (14) ◽  
pp. 1364-1372
Author(s):  
Yu-Hsiang Hsieh ◽  
Mitra K Lewis ◽  
Valentina G Viertel ◽  
Deanna Myer ◽  
Richard E Rothman ◽  
...  

We evaluated the accuracy and perception of a patient self-administered, tablet-facilitated rapid Trichomonas vaginalis (TV) point-of-care (POC) test in adult female emergency department (ED) patients. ED patients undergoing gynecologic examination were eligible. Each consented participant self-collected a vaginal swab, performed a tablet-facilitated TV rapid test using the OSOM® Trichomonas Rapid Test, and completed pre- and post-test self-surveys. After the self-test, the clinician collected one standard-of-care (SOC) vaginal swab for wet-mount testing and two for research. The research coordinator performed the TV rapid test using the clinician-collected swab, and reported the results to the clinician and patient. If the self- and coordinator-performed results were discordant, a TV nucleic acid amplification test (NAAT) was performed in a clinical laboratory. A survey was later administered to providers to assess their perceptions of the utility of the POC TV test. Of the 136 participants, 134 (98.5%) completed self-testing; two had invalid results. Comparing coordinator-performed TV rapid test adjudicated with NAAT, the sensitivity and specificity of self-administered test was 96.0% and 100%, respectively. The wet mount had a sensitivity of 52.0% and specificity of 100%. TV detection increased from 9.6% with wet mount to 18.4% with the TV rapid test. Most women (82.0%) stated self-testing was “not at all hard” (versus 66.2% before testing, p < 0.001). Clinicians indicated the TV rapid test affected their clinical management in 48.5% of cases, including 82.6% of positive cases and 41.6% of negative cases. ED patients were able to reliably collect, perform, and interpret their own POC TV test using tablet instructions. Both participants and providers reported high levels of acceptability of POC TV testing, which nearly doubled rates of TV detection.


2002 ◽  
Vol 41 (01) ◽  
pp. 37-41 ◽  
Author(s):  
S. Shung-Shung ◽  
S. Yu-Chien ◽  
Y. Mei-Due ◽  
W. Hwei-Chung ◽  
A. Kao

Summary Aim: Even with careful observation, the overall false-positive rate of laparotomy remains 10-15% when acute appendicitis was suspected. Therefore, the clinical efficacy of Tc-99m HMPAO labeled leukocyte (TC-WBC) scan for the diagnosis of acute appendicitis in patients presenting with atypical clinical findings is assessed. Patients and Methods: Eighty patients presenting with acute abdominal pain and possible acute appendicitis but atypical findings were included in this study. After intravenous injection of TC-WBC, serial anterior abdominal/pelvic images at 30, 60, 120 and 240 min with 800k counts were obtained with a gamma camera. Any abnormal localization of radioactivity in the right lower quadrant of the abdomen, equal to or greater than bone marrow activity, was considered as a positive scan. Results: 36 out of 49 patients showing positive TC-WBC scans received appendectomy. They all proved to have positive pathological findings. Five positive TC-WBC were not related to acute appendicitis, because of other pathological lesions. Eight patients were not operated and clinical follow-up after one month revealed no acute abdominal condition. Three of 31 patients with negative TC-WBC scans received appendectomy. They also presented positive pathological findings. The remaining 28 patients did not receive operations and revealed no evidence of appendicitis after at least one month of follow-up. The overall sensitivity, specificity, accuracy, positive and negative predictive values for TC-WBC scan to diagnose acute appendicitis were 92, 78, 86, 82, and 90%, respectively. Conclusion: TC-WBC scan provides a rapid and highly accurate method for the diagnosis of acute appendicitis in patients with equivocal clinical examination. It proved useful in reducing the false-positive rate of laparotomy and shortens the time necessary for clinical observation.


2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Huseyin Agah Terzi ◽  
Ozlem Aydemir ◽  
Engin Karakece ◽  
Huseyin Hatipoglu ◽  
Mehmet Olmez ◽  
...  

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.


2020 ◽  
pp. 742-748
Author(s):  
Nada H. Bedair ◽  
Hayder Z. Ali

Trichomonas vaginalis is an eukaryotic parasite that causes the most common non-viral sexually transmitted infection, trichomoniasis. This disease is responsible for many serious health problems such as preterm birth. More than half of the infected women do not develop symptoms, which makes it difficult to diagnose thedisease. In this study, a specific indirect ELISA method was developed to detect anti-Trichomonas vaginalis IgM and IgG immunoglobulins in the sera of infected females. The aim of this study was to investigate the sensitivity of a simple ELISA procedure in comparison to the classical urine examination and vaginal wet mount preparation for the diagnosis of T. vaginalis. The sensitivity of the indirect ELISA was compared with the classical vaginal discharge swab and urine microscopic examination, and the results showed sensitivities of 65.5% and 57.2%, respectively. Furthermore, the infection was measurable as acute or chronic with the refined test.


1996 ◽  
Vol 18 (2) ◽  
pp. 117
Author(s):  
Chris L. Ohlemeyer ◽  
Laurie L. Hornberger ◽  
Daryl A. Lynch ◽  
Ella M. Swierkosz

2002 ◽  
Vol 23 (6) ◽  
pp. 335-337 ◽  
Author(s):  
Cassandra D. Salgado ◽  
Heidi L. Flanagan ◽  
Doris M. Haverstick ◽  
Barry M. Farr

Background:Occupational exposure to human immunodeficiency virus (HIV) is an important threat to healthcare workers. Centers for Disease Control and Prevention guidelines recommend prompt institution of prophylaxis. This requires (1) immediate prophylaxis after exposure, pending test results that may take more than 24 hours in many hospitals; or (2) performance of a rapid test. The Single Use Diagnostic System (SUDS)® HIV-1 Test is used to screen rapidly for antibodies to HIV type 1 in plasma or serum, with a reported sensitivity of more than 99.9%. We used this test from January 1999 until September 2000, when it was withdrawn from the market following reports claiming a high rate of false-positive results.Methods:We reviewed the results of postexposure HIV testing during 21 months.Results:A total of 884 SUDS tests were performed on source patients after occupational exposures (883 negative results, 1 reactive result). The results of repeat SUDS testing on the reactive specimen were also reactive, but the results of enzyme immunoassay and Western blot testing were negative. A new specimen from the same patient showed a negative result on SUDS testing. This suggested a specificity of 99.9%. In the 4 months after SUDS testing was suspended, there was 1 false-positive result on enzyme immunoassay for 1 of 132 source patients (presumed specificity, 99.2%).Conclusion:Use of the SUDS test facilitated rapid and accurate evaluation of source specimens, obviating unnecessary prophylaxis.


2020 ◽  
Author(s):  
Tenzin Tenzin ◽  
Kelzang Lhamo ◽  
Purna B Rai ◽  
Dawa Tshering ◽  
Pema Jamtsho ◽  
...  

Abstract Background: Rabies kills approximately 59,000 people in the world each year worldwide. Rapid and accurate diagnosis of rabies is important for instituting rapid containment measures and for advising the exposed people for postexposure treatment. The application of a rapid diagnostic tests in the field can greatly enhance disease surveillance and diagnostic activities, especially in resource poor settings. In this study, a total of 179 brain tissue samples collected from different rabies suspect animal species (113 dogs, 50 cattle, 10 cats, 3 goats, 2 horses, and 1 bear) were selected and tested using both rapid immunochromatographic kit and the reference standard fluorescent antibody test (FAT). We evaluated the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of a rapid antigen detection test kit produced by BioNote, Inc. (Hwaseong-si, Korea) relative to a FAT for its fit-for-purpose for confirmation of clinical cases of rabies for early response and enhancing rabies surveillance. Results: Among 179 samples examined in this study, there was a concordance in results by the rapid test and FAT in 115 positive samples and 54 negative samples. Test results were discordant in 10 samples which were positive by FAT, but negative (false negative) by rapid kit. The rapid test kit showed a sensitivity of 92% (95% CI: 85.9 – 95.6) and specificity of 100% (95% CI: 93.4 – 100) using FAT as the reference standard. The positive and negative predictive values were found to be 100% (95% CI:96.7 – 100) and 84.4% (95% CI: 73.6 – 91.3), respectively. Overall, there was 94.4% (95% CI: 90 – 96.9) test agreement between rapid test and FAT (Kappa value = 0.874) with a positive percent agreement and negative percent agreement of 92 and 100%, respectively. Conclusions: Our finding demonstrated that the rapid test kit (BioNote) can be used for rabies surveillance and confirming clinical case of rabies in animals for making rapid decisions particularly controlling rabies outbreaks in resource poor settings.


Author(s):  
Yaniv Lustig ◽  
Shlomit Keler ◽  
Rachel Kolodny ◽  
Nir Ben-Tal ◽  
Danit Atias-Varon ◽  
...  

Abstract Background Coronavirus disease 2019 (COVID-19) and dengue fever are difficult to distinguish given shared clinical and laboratory features. Failing to consider COVID-19 due to false-positive dengue serology can have serious implications. We aimed to assess this possible cross-reactivity. Methods We analyzed clinical data and serum samples from 55 individuals with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. To assess dengue serology status, we used dengue-specific antibodies by means of lateral-flow rapid test, as well as enzyme-linked immunosorbent assay (ELISA). Additionally, we tested SARS-CoV-2 serology status in patients with dengue and performed in-silico protein structural analysis to identify epitope similarities. Results Using the dengue lateral-flow rapid test we detected 12 positive cases out of the 55 (21.8%) COVID-19 patients versus zero positive cases in a control group of 70 healthy individuals (P = 2.5E−5). This includes 9 cases of positive immunoglobulin M (IgM), 2 cases of positive immunoglobulin G (IgG), and 1 case of positive IgM as well as IgG antibodies. ELISA testing for dengue was positive in 2 additional subjects using envelope protein directed antibodies. Out of 95 samples obtained from patients diagnosed with dengue before September 2019, SARS-CoV-2 serology targeting the S protein was positive/equivocal in 21 (22%) (16 IgA, 5 IgG) versus 4 positives/equivocal in 102 controls (4%) (P = 1.6E−4). Subsequent in-silico analysis revealed possible similarities between SARS-CoV-2 epitopes in the HR2 domain of the spike protein and the dengue envelope protein. Conclusions Our findings support possible cross-reactivity between dengue virus and SARS-CoV-2, which can lead to false-positive dengue serology among COVID-19 patients and vice versa. This can have serious consequences for both patient care and public health.


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