LB2.60 Field evaluation of a novel dual hiv/syphilis rapid test – malawi, 2014–2015

AbstractWe evaluated the Panbio™ COVID-19 AG Rapid Test Device (RAD) for the diagnosis of COVID-19 in symptomatic patients attended in primary healthcare centers (n=412). Overall specificity and sensitivity of RAD was 100% and 79.6%, respectively, taking RT-PCR as the reference. SARS-CoV-2 could not be cultured from specimens yielding RT-PCR+/RAD- results.

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Field evaluation of a dual rapid Human Immunodeficiency Virus and treponemal syphilis rapid test in community-based clinics in Los Angeles and New York

Diagnostic Microbiology and Infectious Disease ◽

10.1016/j.diagmicrobio.2018.10.002 ◽

2019 ◽

Vol 93 (4) ◽

pp. 325-328

Author(s):

Chrysovalantis Stafylis ◽

Claire C Bristow ◽

Lauren J Natoli ◽

Katheryn R Salow ◽

Emma Davidson ◽

...

Keyword(s):

New York ◽

Human Immunodeficiency Virus ◽

Los Angeles ◽

Rapid Test ◽

Field Evaluation ◽

Community Based ◽

Immunodeficiency Virus

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An assessment of a rapid SARS-CoV-2 antigen test in Bangladesh

10.1101/2021.10.05.21264551 ◽

2021 ◽

Author(s):

Zannat Kawser ◽

Mohabbat Hossain ◽

Sara Suliman ◽

Shahin Lockman ◽

Jesse Gitaka ◽

...

Keyword(s):

False Positive ◽

Rapid Test ◽

Field Evaluation ◽

Ease Of Use ◽

Large Field ◽

Antigen Test ◽

Rt Pcr ◽

Rapid Antigen Detection Test ◽

Antigen Tests ◽

Asymptomatic Individuals

Early detection of SARS-CoV-2 infection is crucial to prevent the spread of the virus. In this study, we evaluated the performance of a commercial rapid antigen detection test, BD Veritor, and compared this (and another rapid test, Standard Q) against a gold-standard of nasopharyngeal (NP) swab tested by reverse transcription-polymerase chain reaction (RT-PCR) in prospectively recruited adults in Dhaka, Bangladesh. We compared the sensitivity and specificity of the two rapid antigen tests against RT-PCR results in 130 symptomatic and 130 asymptomatic adults. In addition, we evaluated the suitability and ease-of-use of the BD Veritor test in a subsample of study participants (n=42) and implementers (n=5). The sensitivity of the BD Veritor rapid antigen 66 test was 70% in symptomatic (95% confidence interval [CI]: 51-85%) and 87% (95% CI: 69-96%) in asymptomatic individuals with positive SARSCoV-2 RT-PCR, for overall sensitivity of 78% (95% CI: 66-88%). The sensitivity of the Standard Q rapid antigen test was 63% (95% CI: 44-69 80%) in symptomatic and 73% (95% CI: 54-87%) in asymptomatic individuals. One false positive in BD Veritor test (specificity 99.5) and no false positive in Standard Q tests were observed (specificity 100%). The BD Veritor rapid antigen test was 78% sensitive when compared with RT-PCR irrespective of the cycle threshold (Ct) levels in this evaluation in Bangladesh. The implementation evaluation data showed good acceptability in the field settings. This warrants large field evaluation as well as use of the rapid antigen test for quick assessment of SARS-CoV-2 for containment of epidemics in the country.

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Field Evaluation of Diagnostic Accuracy of an Oral Fluid Rapid Test for HIV, Tested at Point-of-Service Sites in Rural Zimbabwe

AIDS Patient Care and STDs ◽

10.1089/apc.2008.0225 ◽

2009 ◽

Vol 23 (7) ◽

pp. 571-576 ◽

Cited By ~ 31

Author(s):

Sophie J.S. Pascoe ◽

Lisa F. Langhaug ◽

James Mudzori ◽

Eileen Burke ◽

Richard Hayes ◽

...

Keyword(s):

Diagnostic Accuracy ◽

Oral Fluid ◽

Rapid Test ◽

Field Evaluation ◽

Point Of Service

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EBOLA Ag K-SeT rapid test: field evaluation in Sierra Leone

Clinical Microbiology and Infection ◽

10.1016/j.cmi.2017.10.019 ◽

2018 ◽

Vol 24 (6) ◽

pp. 653-657 ◽

Cited By ~ 4

Author(s):

F. Colavita ◽

M. Biava ◽

P. Mertens ◽

Q. Gilleman ◽

C. Borlon ◽

...

Keyword(s):

Sierra Leone ◽

Rapid Test ◽

Field Evaluation ◽

Test Field

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Laboratory and field evaluation of the STANDARD Q and PanbioTM SARS-CoV-2 antigen rapid test in Namibia using nasopharyngeal samples

10.1101/2021.09.21.21263886 ◽

2021 ◽

Author(s):

Iyaloo SN Konstantinus ◽

Douglas Chiwara ◽

Emmy-Else Ndevaetela ◽

Victoria Ndarukwa-Phiri ◽

Nathalia !Garus-oas ◽

...

Keyword(s):

Scale Up ◽

Rapid Test ◽

High Specificity ◽

Field Evaluation ◽

Laboratory Evaluation ◽

Rapid Diagnostics ◽

Rt Pcr ◽

Negative Results ◽

Scarcity Of Resources ◽

Rule Out

Abstract Background As new SARS-CoV-2 variants of concern emerge, there is a need to scale up testing to minimize transmission of the Coronavirus disease 2019 (COVID-19). Many countries especially those in the developing world continue to struggle with scaling up reverse transcriptase polymerase reaction (RT-PCR) to detect SARS-CoV-2 due to scarcity of resources. Alternatives such as antigen rapid diagnostics tests (Ag-RDTs) may provide a solution to enable countries to scale up testing. Methods In this study, we evaluated the PanbioTM and STANDARD Q Ag-RDTs in the laboratory using 80 COVID-19 RT-PCR confirmed and 80 negative nasopharyngeal swabs. The STANDARD-Q was further evaluated in the field on 112 symptomatic and 61 asymptomatic participants. Results For the laboratory evaluation, both tests had a sensitivity above 80% (PanbioTM = 86% vs STANDARD Q = 88%). The specificity of the PanbioTM was 100%, while that of the STANDARD Q was 99%. When evaluated in the field, the STANDARD Q maintained a high specificity of 99%, however the sensitivity was reduced to 56%. Conclusion Using Ag-RDTs in low resource settings will be helpful, however, negative results should be confirmed by RT-PCR where possible to rule out COVID-19 infection.

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Field Evaluation of the InBios Chagas Detect Plus Rapid Test in Serum and Whole-Blood Specimens in Bolivia

Clinical and Vaccine Immunology ◽

10.1128/cvi.00609-14 ◽

2014 ◽

Vol 21 (12) ◽

pp. 1645-1649 ◽

Cited By ~ 15

Author(s):

Vishal Shah ◽

Lisbeth Ferrufino ◽

Robert H. Gilman ◽

Margot Ramirez ◽

Eliana Saenza ◽

...

Keyword(s):

Chagas Disease ◽

Whole Blood ◽

Rapid Test ◽

Antibody Test ◽

Field Evaluation ◽

Evidence Base ◽

Enzyme Linked Immunosorbent Assay ◽

Laboratory Equipment ◽

Content Type ◽

Blood Specimens

ABSTRACTTrypanosoma cruzicauses Chagas disease, which affects an estimated 7 million to 8 million people. Chagas disease is endemic throughout Latin America, with the highest prevalence in Bolivia. Conventional diagnosis requires a well-equipped laboratory with experienced personnel. We evaluated the Chagas Detect Plus (CDP) (InBios, Seattle, WA), a rapid immunochromatographic assay for IgG antibodies toT. cruzi. CDP performance was compared to infection status based on results obtained by indirect hemagglutination assay, immunofluorescent-antibody test, and enzyme-linked immunosorbent assay. Confirmed infection required positive results by at least 2 conventional assays. We used specimens from adults of both sexes in a general hospital in the city of Santa Cruz and from pregnant women in a hospital and children in villages in the Bolivian Chaco, an area of hyperendemicity. CDP was performed in paired whole-blood and serum specimens from 385 individuals in the two hospital studies and in 200 serum specimens from the community study. CDP showed sensitivities/specificities of 96.2% (95% confidence interval, 92.7 to 98.4)/98.8% (95.9 to 99.9) in whole blood and 99.3% (97.5 to 99.9)/96.9% (94.2 to 98.6) in serum, with no differences by sex, age group, or study site. CDP showed excellent sensitivity and specificity in our study population, comparable to those of conventional serology. The test is reliable for field surveys, requires no laboratory equipment, and performed well in serum and whole blood. The CDP could also be used for accurate maternal screening to identify neonates at risk of congenital transmission. CDP performance data in diverse geographic areas are needed to strengthen the evidence base for its use.

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Field evaluation of a rapid antigen test (Panbio™ COVID-19 Ag Rapid Test Device) for COVID-19 diagnosis in primary healthcare centres

Clinical Microbiology and Infection ◽

10.1016/j.cmi.2020.11.004 ◽

2020 ◽

Cited By ~ 1

Author(s):

Eliseo Albert ◽

Ignacio Torres ◽

Felipe Bueno ◽

Dixie Huntley ◽

Estefanía Molla ◽

...

Keyword(s):

Primary Healthcare ◽

Rapid Test ◽

Field Evaluation ◽

Antigen Test ◽

Test Device

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Field evaluation of a schistosome circulating cathodic antigen rapid test kit at point-of-care for mapping of schistosomiasis endemic districts in The Gambia

PLoS ONE ◽

10.1371/journal.pone.0182003 ◽

2017 ◽

Vol 12 (8) ◽

pp. e0182003 ◽

Cited By ~ 12

Author(s):

Bakary Sanneh ◽

Ebrima Joof ◽

Abdoulie M. Sanyang ◽

Kristen Renneker ◽

Yaya Camara ◽

...

Keyword(s):

Point Of Care ◽

Rapid Test ◽

Field Evaluation ◽

The Gambia ◽

Test Kit

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Field Evaluation of Calypte’s AWARETM Blood Serum Plasma (BSP) and Oral Mucosal Transudate (OMT) Rapid Tests for Detecting Antibodies to HIV-1 and 2 in Plasma and Oral Fluid

The Open AIDS Journal ◽

10.2174/1874613600903010014 ◽

2009 ◽

Vol 3 (1) ◽

pp. 14-18 ◽

Cited By ~ 5

Author(s):

George A Alemnji ◽

Gisele A Ngulefac ◽

Peter M Ndumbe ◽

Tazoacha Asonganyi

Keyword(s):

Blood Serum ◽

Predictive Value ◽

Rapid Test ◽

Field Evaluation ◽

Ease Of Use ◽

Test Kit ◽

Rapid Tests ◽

Sensitivity Specificity ◽

Mean Cost ◽

Hiv 1

As programs to prevent and care for HIV-infected persons are scaled-up in Africa, there is the need for continuous evaluation of the performance of test kits that could best support these programs. The present study evaluated the sensitivity, specificity, ease of use, and cost of AWARE TM Blood Serum Plasma (BSP) and Oral Mucosal Transudate (OMT) Rapid HIV-1/2 test kits using real-time and archived samples of HIV-infected persons from Cameroon. Matched whole blood and OMT specimens were collected prospectively from HIV-positive and HIV-negative persons from different regions of Cameroon and tested using the AWARE TM BSP and OMT test kits, respectively. These results were compared to the gold standard that included a combination of Determine HIV-1/2 and Enzygnost HIV-1/2. The BSP Rapid test kit was further evaluated using well characterized panels of HIV-2 and HIV-1 group O samples. Cost and end-user analysis of the OMT test kit was done by comparing its actual cost, consumables, safety, bench time and manipulation with other test kits. Of the 732 matched samples, 412 (56.3%) and 320 (43.7%) were from females and males, respectively. Of these samples, 23 (3.1%) gave discordant results between Determine HIV-1/2 and Enzygnost HIV1/2 and were excluded from the analysis. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the AWARETM BSP were 100%. The AWARETM OMT had 98.8% sensitivity, 98.9% specificity, 98.0% PPV and 99.4% NPV. The results of a well-characterized archived panel of HIV-2 (n=7) and HIV-1 group O (n=3) samples using the AWARETM BSP Rapid test kit gave 100% concordance. Total per patient cost of the AWARE OMT rapid test kit was US$4.72 compared to a mean cost of US $7.33 + 0.11 for the other test kits. Both the AWARETM BSP and OMT Rapid test kits demonstrated high sensitivities and specificities on all samples tested and were well adapted for use in resource-constrained settings with high HIV heterogeneity such as Cameroon. The AWARE TM HIV-1/2 OMT Rapid test kit appears to be the cheapest, safest and easiest to use compared with other available test kits.

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