Evaluation of the Tuberculin Gamma Interferon Assay: Potential To Replace the Mantoux Skin Test

Pottumarthy, Sudha; Morris, Arthur J.; Harrison, A C; Wells, Virginia C.

doi:10.1128/jcm.37.10.3229-3232.1999

Cited by 100 publications

(39 citation statements)

References 9 publications

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“…The kappa statistic was used to measure the strength of agreement between the results by the new rapid test and the new ELISA. Kappa statistic values of Ͼ0.75, 0.40 to 0.75, and Ͻ0.40 represent excellent agreement, good to fair agreement, and poor agreement, respectively (11). For the data analysis for ELISA, an arbitrary cutoff value of 0.45 was selected but confirmed with the delta values (2), which could provide an indication of an optimal differentiation between the positive and negative populations.…”

Section: Methodsmentioning

confidence: 99%

“…Agreement between the new rapid test and the new ELISA with sera from SARS patients and healthy controls A kappa statistic of Ն0.75 represents excellent agreement, 0.40 to 0.75 represents good-to-fair agreement, and Ͻ0.40 represents poor agreement(11). least for the exclusion of SARS in testing patients as advocated by the Centers for Disease Control and Prevention (CDC).…”

mentioning

confidence: 99%

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Recombinant Protein-Based Enzyme-Linked Immunosorbent Assay and Immunochromatographic Tests for Detection of Immunoglobulin G Antibodies to Severe Acute Respiratory Syndrome (SARS) Coronavirus in SARS Patients

Guan

Chen

Foo

et al. 2004

Clin Vaccine Immunol

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An enzyme-linked immunosorbent assay (ELISA) and a rapid immunochromatographic test for detection of immunoglobulin G (IgG) antibodies in severe acute respiratory syndrome (SARS) patients were developed by utilizing the well-characterized recombinant proteins Gst-N and Gst-U274. The ELISA detected IgG antibodies to SARS-CoV in all 74 convalescent-phase samples from SARS patients while weakly cross-reacting to only 1 of the 210 control sera from healthy donors. This finding thus led to a kit sensitivity, specificity, and accuracy of 100, 99.5, and 99.6%, respectively. The test thus provided a positive predictive value (PPV) of 98.7% and a negative predictive value (NPV) of 100%. In addition, the ELISA gave a positive delta of 5.4 and a negative delta of 3.6, indicating an excellent differentiation between positives and negatives. The same recombinant proteins were also applied to a newly developed platform for the development of a 15-min rapid test. The resulting rapid test has an excellent agreement of 99.6%, with a kappa value of 1.00, with the ELISA. Again, this rapid test was able to detect 100% of the samples tested (n ‫؍‬ 42) while maintaining a specificity of 99.0% (n ‫؍‬ 210). The PPV and NPV for the rapid test thus reached 95.3 and 100%, respectively.

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Section: Methodsmentioning

confidence: 99%

mentioning

confidence: 99%

Recombinant Protein-Based Enzyme-Linked Immunosorbent Assay and Immunochromatographic Tests for Detection of Immunoglobulin G Antibodies to Severe Acute Respiratory Syndrome (SARS) Coronavirus in SARS Patients

Guan

Chen

Foo

et al. 2004

Clin Vaccine Immunol

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show abstract

“…The kappa statistic was used to measure the strength of an agreement between the results by the new rapid test and the new ELISA. A kappa statistic of Ͼ0.75, 0.40 to 0.75, or Ͻ0.40 represents excellent, good to fair, or poor agreement, respectively (10). Table 1, three cutoff values at OD of 0.45, 0.30, and 0.25 were used to evaluate the performance of the ELISA.…”

Section: Methodsmentioning

confidence: 99%

Evaluation and Validation of an Enzyme-Linked Immunosorbent Assay and an Immunochromatographic Test for Serological Diagnosis of Severe Acute Respiratory Syndrome

Guan

Chan

Peiris

et al. 2004

Clin Vaccine Immunol

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A newly developed severe acute respiratory syndrome (SARS)-specific enzyme-linked immunosorbent assay (ELISA) was further validated to confirm cutoff values and evaluate its diagnostic performance with clinical samples. In parallel, an immunochromatographic test was also evaluated. A total of 227 clinical serum specimens collected from SARS patients were used in the study, together with 385 samples from healthy donors. By use of an immunofluorescent (IF) test as the "gold standard, " both the ELISA and the immunochromatographic test were able to detect immunoglobulin G antibodies to SARS not only from late-convalescent-stage samples (>21 days from the onset of clinical symptoms), as previously established, but also from early-acute-phase samples (1 to 10 days from onset). The ELISA, using an optical density (OD) of 0.25 as its cutoff value, produced the best sensitivity while maintaining high specificity. It detected SARS-specific antibodies in 58, 70, 75, and 95%, respectively, of the four groups of samples collected from patients 1 to 10 days, 11 to 20 days, 21 to 30 days, and more than 30 days after the onset of clinical symptoms. Similarly, the immunochromatographic test detected SARS-specific antibodies in 55, 68, 81, and 79% of the four groups, respectively. The overall specificities for the ELISA and the rapid test were 99.5 and 97.7%, respectively. Although the positive correlation observed between the ELISA OD values and the IF titers was moderate (r ‫؍‬ 0.6915; P < 0.001), the detection rates of both the ELISA and the rapid test were found well in agreement with the IF titers.The newly emerged severe acute respiratory syndrome (SARS) is a serious respiratory illness of global significance. Its highly contagious nature, combined with its high mortality rate, has proven disruptive and costly in an increasingly globalized world. As new cases appear to be reemerging in January 2004, the urgency for prompt identification and isolation of infected patients remains. Although the identification of the novel coronavirus SARS coronavirus (SARS-CoV) as the etiological agent for SARS (3, 4, 7, 9) made it possible for various tests to be developed, providing tools for laboratory diagnosis remains a priority, as suggested by the World Health Organization (WHO). To date, there is still no standardized test for diagnosing SARS regardless of whether tests are antigen based or antibody based (http://www.who.int/csr/sars/conference/june _2003/materials/presentations/en/laboratorydiagnosis.pdf). In this regard, various immunofluorescent (IF) tests were essentially used as the "gold standards" for serodiagnosis of SARS during the 2003 outbreak. Although these IF protocols were found to be well correlated with PCR and clinical outcomes (9), they differed from laboratory to laboratory and were technically very demanding. In addition, these protocols utilized virus-infected materials and thus required laboratories with biosafety-level-3 facilities under current regulations. Hence, alternative tests with standardized approache...

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“…Test line and <0.40 represented excellent agreement, good to fair agreement, and poor agreement, respectively [25].…”

Section: Control Linementioning

confidence: 98%

Development and evaluation of an immunochromatographic strip for rapid detection of porcine hemagglutinating encephalomyelitis virus

Chen

Zhao

Song

et al. 2012

Virol J

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BackgroundThe incidence of PHE among pigs in many countries is on the rise, and it has caused great economic losses to the pig industry. Therefore, the development of a sensitive, specific, and easily-performed assay is crucial for the rapid detection and surveillance of PHE-CoV infection and transmission.ResultsAn immunochromatographic strip was developed for the detection of PHE-CoV. The colloidal gold-labeled MAb 4D4 was used as the detection reagent, and the MAb 1E2 and goat anti-mouse IgG coated the strip's test and control lines, respectively. The immunochromatographic strip was capable of specifically detecting PHE-CoV with a HA unit of 2 within 10 min. Storage of the strips at room temperature for 6 months or at 4°C for 12 months did not change their sensitivity or specificity. Using RT-PCR as a reference test, the relative specificity and sensitivity of the immunochromatographic strip were determined to be 100% and 97.78%, respectively. There was an excellent agreement between the results obtained by RT-PCR and the immunochromatographic strips (kappa = 0.976). Additionally, there was a strong agreement between the sandwich enzyme-linked immunosorbent assay (ELISA) and immunochromatographic strips (Kappa = 0.976). When the immunochromatographic strips were used for diagnosing PHE-CoV infection in the Jilin Province, the PHE-CoV-positive rate ranged from 61.54% in the Jilin district to 17.95% in the Songyuan district.ConclusionsBased on its high specificity, sensitivity, and stability, the immunochromatographic strip would be suitable for on-site detection of PHE-CoV for surveillance and epidemiological purposes.

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Evaluation of the Tuberculin Gamma Interferon Assay: Potential To Replace the Mantoux Skin Test

Cited by 100 publications

References 9 publications

Recombinant Protein-Based Enzyme-Linked Immunosorbent Assay and Immunochromatographic Tests for Detection of Immunoglobulin G Antibodies to Severe Acute Respiratory Syndrome (SARS) Coronavirus in SARS Patients

Recombinant Protein-Based Enzyme-Linked Immunosorbent Assay and Immunochromatographic Tests for Detection of Immunoglobulin G Antibodies to Severe Acute Respiratory Syndrome (SARS) Coronavirus in SARS Patients

Evaluation and Validation of an Enzyme-Linked Immunosorbent Assay and an Immunochromatographic Test for Serological Diagnosis of Severe Acute Respiratory Syndrome

Development and evaluation of an immunochromatographic strip for rapid detection of porcine hemagglutinating encephalomyelitis virus

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