Rapid diagnostic tests for tuberculosis: progress but no gold standard.

1997 ◽  
Vol 155 (5) ◽  
pp. 1497-1498 ◽  
Author(s):  
P F Barnes
Keyword(s):  
Gold Standard ◽  
Diagnostic Tests ◽  
Rapid Diagnostic Tests ◽  
No Gold Standard

scholarly journals Evaluation of two new rapid diagnostic tests (RDTs) for the diagnosis of malaria

2013 ◽  
Vol 5 (2) ◽  
pp. 11-15 ◽  
Author(s):  
Fahmida Jahan ◽  
Rubayet Elahi ◽  
Md. Khaja Mohiuddin ◽  
Md. Gulam Musawwir Khan ◽  
Mohammad Shafiul Alam ◽  
...  
Keyword(s):  
Predictive Value ◽  
Gold Standard ◽  
Diagnostic Tests ◽  
Rapid Diagnostic Tests ◽  
Accurate Diagnosis ◽  
The Other ◽  
Antibody Detection ◽  
Resource Limited Settings ◽  
Malaria Rdts ◽  
Resource Limited

Rapid diagnostic tests (RDTs) address the need for accurate diagnosis of malaria, particularly in resource limited settings. In this study, two malaria RDTs were compared with gold standard microscopy: On Site Pf/Pv test detecting Plasmodium falciparum-specific histidine rich protein-2 (Pf HR P2) and P. vivax-specific parasitic lactate dehydrogenase (pLDH) antigens; and SD Bioline anti-Pf/Pv test detecting anti-HR P2 and anti-pL DH antibodies for the diagnosis of P. falciparum and P. vivax infections, respectively. For OnSite test, the overall sensitivity was found 96.2% , specificity 98.2% , positive predictive value (PPV ) 98.2% , negative predictive value (NPV ) 96.4% and agreement with microscopy was found to be 0.94. On the other hand SD Bioline test, the overall sensitivity was 75.4%, specificity 83.7%, PPV 84.3% , NPV 74.5% and agreement with microscopy was 0.59. These data revealed that the R DT based on antigen detection (Onsite test) was more reliable than that based on the antibody detection (SD Bioline test).DOI: http://dx.doi.org/10.3329/bjmm.v5i2.16931 Bangladesh J Med Microbiol 2011; 05 (02): 11-15

scholarly journals Evaluation of diagnostic tests when there is no gold standard. A review of methods

2007 ◽  
Vol 11 (50) ◽  
Author(s):  
A Rutjes ◽  
J Reitsma ◽  
A Coomarasamy ◽  
K Khan ◽  
P Bossuyt
Keyword(s):  
Gold Standard ◽  
Diagnostic Tests ◽  
No Gold Standard

The diagnostic performance of rapid diagnostic tests and microscopy for malaria diagnosis in eastern Sudan using a nested polymerase chain reaction assay as a reference standard

2019 ◽  
Vol 113 (11) ◽  
pp. 701-705 ◽  
Author(s):  
Zakya A Abdalla ◽  
NourElhouda A Rahma ◽  
Elhashimi E Hassan ◽  
Tajeldin M Abdallah ◽  
Hadeel E Hamad ◽  
...  
Keyword(s):  
Polymerase Chain Reaction ◽  
Gold Standard ◽  
Diagnostic Tests ◽  
Diagnostic Performance ◽  
Malaria Diagnosis ◽  
Rapid Diagnostic Tests ◽  
Chain Reaction ◽  
Nested Polymerase Chain Reaction ◽  
Polymerase Chain ◽  
Eastern Sudan

Abstract Background Accurate diagnosis of malaria infection is essential for successful control and management of the disease. Both microscopy and rapid diagnostic tests (RDTs) are recommended for malaria diagnosis, however, RDTs are more commonly used. The aim of the current study was to assess the performance of microscopy and RDTs in the diagnosis of Plasmodium falciparum infection using a nested polymerase chain reaction (PCR) assay as the gold standard. Methods A cross-sectional study was carried out in Kassala Hospital, eastern Sudan. A total of 341 febrile participants of all ages were recruited. Blood specimens were collected and malaria testing was performed using an RDT (SD Bioline Malaria Ag Pf), microscopy and nested PCR. The sensitivity, specificity, positive and negative predictive values (PPV and NPV, respectively) of microscopy and the RDT were investigated. Results The prevalence of P. falciparum malaria infections in this study was 22.9%, 24.3% and 26.7% by PCR, microscopy and RDT, respectively. Compared with microscopy, the RDT had slightly higher sensitivity (80.7% vs 74.3%; p=0.442), equivalent specificity (89.3% vs 90.4%), a similar PPV (69.2% vs 69.8%) and a higher NPV (94.0% vs 92.2%). Conclusions The diagnostic performance of the RDT was better than that of microscopy in the diagnosis of P. falciparum malaria when nested PCR was used as the gold standard.

Estimation of infection prevalence and sensitivity in a stratified two-stage sampling design employing highly specific diagnostic tests when there is no gold standard

2015 ◽  
Vol 34 (25) ◽  
pp. 3349-3361 ◽  
Author(s):  
Ezer Miller ◽  
Amit Huppert ◽  
Ilya Novikov ◽  
Alon Warburg ◽  
Asrat Hailu ◽  
...  
Keyword(s):  
Gold Standard ◽  
Diagnostic Tests ◽  
Sampling Design ◽  
Infection Prevalence ◽  
Two Stage ◽  
No Gold Standard

scholarly journals Performance Evaluation of Standard Health System Microscopy and Rapid Diagnostic Test for the Focused Screening and Treatment of Malaria in South-eastern Tanzania

2021 ◽  
Author(s):  
lin kangming ◽  
Duoquan Wang ◽  
Prosper Chaki ◽  
Michael Mihayo ◽  
Fei Luo ◽  
...  
Keyword(s):  
Health System ◽  
Gold Standard ◽  
Diagnostic Tests ◽  
Diagnostic Performance ◽  
False Negative ◽  
Rapid Diagnostic Tests ◽  
Malaria Burden ◽  
South Eastern ◽  
Local Standard ◽  
Sensitivity Specificity

Abstract Background: The Focused screening and treatment (FSAT) has been identified as one of the key approaches for reducing the malaria burden in Tanzania. However, the diagnostic performance of the local standard health system microscopy and rapid diagnostic tests (RDT) for the malaria infections is yet to be established. Thus, we aimed to evaluate the performance of the local standard health system microscopy and RDTs in comparison to that of the gold standard modality through the re-examination of blood slide microscopy findings. Methods: We used the paired RDTs and standard health system microscopy results from the participants screened in the FSAT during 2015–2016. With the gold standard modality as reference, the results of local standard health system microscopy and RDTs were evaluated according to their sensitivity, specificity and reliability.Results: A total of 1,497 paired standard health system microscopy and RDTs results were analysed. Of these, 679 (45.4%) samples and 818 (54.6%) samples were from the high transmission areas (HTA) and low transmission areas (LTA) in the Rufiji District of south eastern Tanzania, respectively. With the gold standard as the reference, the sensitivity of RDTs were higher than those of standard health system microscopy (87.10% vs 76.88%) and (86.99% vs 65.04%) in the HTA and LTA, respectively. Further, the false-negative rates of RDTs were lower than those of standard microscopy in both HTA (12.90% vs 13.01%) and LTA (23.12% vs 34.96%). Conclusions: RDTs have better performance than the standard health system microscopy in terms of sensitivity and specificity for FSAT in study areas in Tanzania.

scholarly journals Laboratory evaluation of the rapid diagnostic tests for the detection of Vibrio cholerae O1 using diarrheal samples

2021 ◽  
Vol 15 (6) ◽  
pp. e0009521
Author(s):  
Goutam Chowdhury ◽  
Tarosi Senapati ◽  
Bhabatosh Das ◽  
Asha Kamath ◽  
Debottam Pal ◽  
...  
Keyword(s):  
Vibrio Cholerae ◽  
Sensitivity And Specificity ◽  
Gold Standard ◽  
Diagnostic Tests ◽  
Diarrheal Disease ◽  
High Sensitivity ◽  
Rapid Diagnostic Tests ◽  
Laboratory Evaluation ◽  
Specificity And Sensitivity ◽  
Stool Samples

Background Cholera, an acute diarrheal disease is a major public health problem in many developing countries. Several rapid diagnostic tests (RDT) are available for the detection of cholera, but their efficacies are not compared in an endemic setting. In this study, we have compared the specificity and sensitivity of three RDT kits for the detection of Vibrio cholerae O1 and compared their efficiency with culture and polymerase chain reaction (PCR) methods. Methods Five hundred six diarrheal stool samples collected from patients from two different hospitals in Kolkata, India were tested using SD Bioline Cholera, SMART-II Cholera O1 and Crystal-VC RDT kits. All the stool samples were screened for the presence of V. cholerae by direct and enrichment culture methods. Stool DNA-based PCR assay was made to target the cholera toxin (ctxAB) and O1 somatic antigen (rfb) encoding genes. Statistical evaluation of the RDTs has been made using STATA software with stool culture and PCR results as the gold standards. The Bayesian latent class model (LCM) was used to evaluate the diagnostic tests in the absence of the gold standard. Results Involving culture technique as gold standard, the sensitivity and specificity of the cholera RDT kits in the direct testing of stools was highest with SAMRT-II (86.1%) and SD-Cholera (94.4%), respectively. The DNA based PCR assays gave very high sensitivity (98.4%) but the specificity was comparatively low (75.3%). After enrichment, the high sensitivity and specificity was detected with SAMRT-II (78.8%) and SD-Cholera (99.1%), respectively. Considering PCR as the gold standard, the sensitivity and specificity of the RDTs remained between 52.3–58.2% and 92.3–96.8%, respectively. In the LCM, the sensitivity of direct and enrichment testing was high in SAMRT-II (88% and 92%, respectively), but the specificity was high in SD cholera for both the methods (97% and 100%, respectively). The sensitivity/specificity of RDTs and direct culture have also been analyzed considering the age, gender and diarrheal disease severity of the patients. Conclusion Overall, the performance of the RDT kits remained almost similar in terms of specificity and sensitivity. Performance of PCR was superior to the antibody-based RDTs. The RTDs are very useful in identifying cholera cases during outbreak/epidemic situations and for making them as a point-of-care (POC) testing tool needs more improvement.

scholarly journals Performance Evaluation of the Elecsys Syphilis Assay for the Detection of Total Antibodies to Treponema pallidum

2014 ◽  
Vol 22 (1) ◽  
pp. 17-26 ◽  
Author(s):  
Martin Enders ◽  
Andrea Hunjet ◽  
Michael Gleich ◽  
Roland Imdahl ◽  
Annelies Mühlbacher ◽  
...  
Keyword(s):  
Gold Standard ◽  
Diagnostic Tests ◽  
Epstein Barr Virus ◽  
Blood Donation ◽  
Early Stage ◽  
Treponema Pallidum ◽  
Routine Clinical Practice ◽  
Barr Virus ◽  
Epstein Barr ◽  
No Gold Standard

ABSTRACTSyphilis is a health problem of increasing incidence in recent years that may have severe complications if not diagnosed and treated at an early stage. There are many diagnostic tests available for syphilis, but there is no gold standard, and diagnosis therefore usually relies upon a combination of tests. In this multicenter study, we evaluated the treponemal Elecsys syphilis assay for use in the diagnosis of syphilis in routine samples, i.e., when syphilis is suspected or during antenatal or blood donation screening. The sensitivity and specificity of the Elecsys syphilis assay were compared head to head with those of other treponemal assays used in routine clinical practice and were assessed in potentially cross-reactive samples from patients with Epstein-Barr virus, HIV, and Lyme disease. In a total of 8,063 syphilis-negative samples collected from routine diagnostic requests and blood donations, the Elecsys syphilis assay had a specificity of 99.88%. In 928 samples previously identified as syphilis positive, the sensitivity was 99.57 to 100% (the result is presented as a range depending on whether four initially indeterminate samples are included in the assessment). The specificity of the Elecsys syphilis assay in patients with other infections was 100%; no false-positive samples were identified.

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