Development and Evaluation of a Point-of-Care Test in a Low-Resource Setting with High Rates of Chlamydia trachomatis Urogenital Infections in Fiji

Dean, Deborah; Swaminathan, Sumeetha; Kama, Mike; Goemans, Sophie; Faktaufon, Daniel; Alnabelseya, Noor; Spelke, Dawn P.; Kahrizi, Kamin; Black, Matthew; Mitra, Debkishore

doi:10.1128/jcm.00182-21

Cited by 9 publications

(5 citation statements)

References 35 publications

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“…The positivity rate for these three pathogens was extremely high in our series, which may explain the frequency of MG co-infections with CT (13/22, 59%) and NG (9/22, 41.0%). As in other Melanesian populations, 11–14 this high prevalence of curable STIs suggests the possibility of widespread asymptomatic carriage, which may also explain the low rate of urethritis considered idiopathic in our study.…”

Section: Discussionsupporting

confidence: 81%

Prevalence of Mycoplasma genitalium and other sexually transmitted pathogens in male urethritis in a sexual health centre in New Caledonia

Blanco¹,

Rachline²,

Tarantola

et al. 2022

Int J STD AIDS

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Background: The prevalence of sexually transmitted infections (STIs) is high in New Caledonia (NC), but there are no data on Mycoplasma genitalium (MG). However, the syndromic treatment of urethritis used in the territory includes a single dose of azithromycin, which could generate resistance in MG. Methods: We recruited 217 men referred to the Noumea public medical centre (CMP) with signs of urethritis and meeting the inclusion criteria from May 2016 to March 2018. Each was tested for Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT), Trichomonas vaginalis (TV) and for the first time in NC for MG by polymerase chain reaction (PCR). Results: The prevalence of MG was 10.1% (22/217). Azithromycin resistance of MG (mutation in the 23S rRNA gene) could only be assessed for 10 of the 22 strains. Only one (1/10; 10%) was resistant. The prevalence of other STIs tested was high, as CT, NG and/or TV were associated in 77.3% (17/22) of MG-positive cases. Conclusions: Although co-infections further justify syndromic management, the presence of MG in NC urethritis cases could call treatment guidelines into question.

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Section: Discussionsupporting

confidence: 81%

Prevalence of Mycoplasma genitalium and other sexually transmitted pathogens in male urethritis in a sexual health centre in New Caledonia

Blanco¹,

Rachline²,

Tarantola

et al. 2022

Int J STD AIDS

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“…Choopara et al ( 2017 ) and Somboonna and Choopara ( 2019 ) combined LAMP with hydroxynaphthol blue for visual color detection of C. trachomatis by the naked eye, but the results of this assay were ambiguous when LAMP product concentrations were low. Dean et al ( 2021 ) have also utilized the LAMP assay for testing C. trachomatis , and the C. trachomatis -LAMP amplification products were examined with colorimetric chemistry, which must rely on optical detection instrumentation. In this study, we first combined LAMP amplification with LFB for the identification of C. trachomatis , which is more convenient and rapid than other methods.…”

Section: Discussionmentioning

confidence: 99%

Nanoparticle-Based Lateral Flow Biosensor Integrated With Loop-Mediated Isothermal Amplification for Rapid and Visual Identification of Chlamydia trachomatis for Point-of-Care Use

Chen

Zhou

Tan³

et al. 2022

Front. Microbiol.

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Chlamydial infection, caused by Chlamydia trachomatis, is the most common bacterial sexually transmitted infection and remains a major public health problem worldwide, particularly in underdeveloped regions. Developing a rapid and sensitive point-of-care (POC) testing for accurate screening of C. trachomatis infection is critical for earlier treatment to prevent transmission. In this study, a novel diagnostic assay, loop-mediated isothermal amplification integrated with gold nanoparticle-based lateral flow biosensor (LAMP-LFB), was devised and applied for diagnosis of C. trachomatis in clinical samples. A set of LAMP primers based on the ompA gene from 14 C. trachomatis serological variants (serovar A-K, L1, L2, L3) was successfully designed and used for the development of C. trachomatis-LAMP-LFB assay. The optimal reaction system can be performed at a constant temperature of 67°C for 35 min. The total assay process, including genomic DNA extraction (~15 min), LAMP reaction (35 min), and LFB readout (~2 min), could be finished within 60 min. The C. trachomatis-LAMP-LFB could detect down to 50 copies/ml, and the specificity was 100%, no cross-reactions with other pathogens were observed. Hence, our C. trachomatis-LAMP-LFB was a rapid, reliable, sensitive, cost-effective, and easy-to-operate assay, which could offer an attractive POC testing tool for chlamydial infection screening, especially in resource starvation settings.

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“…Our findings demonstrate a close correlation between the laboratory assay and the POC test; thus, the Healgen LFA offers a potentially cost-effective way of identifying anti-S positivity while undertaking large-scale SARS-CoV-2 sero-epidemiological studies. Success in the use of POC tests for disease screening, particularly in low-resource healthcare settings, has been demonstrated for many non-coronavirus conditions, such as HIV ( 42 ), malaria ( 43 ), sickle cell disease ( 44 ), and chlamydia ( 45 ). This test modality may benefit patients in healthcare settings where laboratory facilities, result turnaround, and follow-up options are limited ( 46 ).…”

Section: Discussionmentioning

confidence: 99%

Point of care detection of SARS-CoV-2 antibodies and neutralisation capacity—lateral flow immunoassay evaluation compared to commercial assay to inform potential role in therapeutic and surveillance practices

McGrath,

O'Doherty,

Conlon

et al. 2023

Front. Public Health

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IntroductionAs the COVID-19 pandemic moves towards endemic status, testing strategies are being de-escalated. A rapid and effective point of care test (POCT) assessment of SARS-CoV-2 immune responses can inform clinical decision-making and epidemiological monitoring of the disease. This cross-sectional seroprevalence study of anti-SARS-CoV-2 antibodies in Irish healthcare workers assessed how rapid anti-SARS-CoV-2 antibody testing can be compared to a standard laboratory assay, discusses its effectiveness in neutralisation assessment and its uses into the future of the pandemic.MethodsA point of care lateral flow immunoassay (LFA) detecting anti-SARS-CoV-2 spike (S)-receptor binding domain (RBD) neutralising antibodies (Healgen SARS-CoV-2 neutralising Antibody Rapid Test Cassette) was compared to the Roche Elecsys/-S anti-SARS-CoV-2 antibody assays and an in vitro surrogate neutralisation assay. A correlation between anti-spike (S), anti-nucleocapsid (N) titres, and in vitro neutralisation was also assessed.Results1,777 serology samples were tested using Roche Elecsys/-S anti-SARS-CoV-2 assays to detect total anti-N/S antibodies. 1,562 samples were tested using the POC LFA (including 50 negative controls), and 90 samples were tested using an in vitro ACE2-RBD binding inhibition surrogate neutralisation assay. The POCT demonstrated 97.7% sensitivity, 100% specificity, a positive predictive value (PPV) of 100%, and a negative predictive value (NPV) of 61% in comparison to the commercial assay. Anti-S antibody titres determined by the Roche assay stratified by the POC LFA result groups demonstrated statistically significant differences between the “Positive” and “Negative” LFA groups (p < 0.0001) and the “Weak Positive” and “Positive” LFA groups (p < 0.0001). No statistically significant difference in ACE2-RBD binding inhibition was demonstrated when stratified by the LFA POC results. A positive, statistically significant correlation was demonstrated between the in vitro pseudo-neutralisation assay results and anti-S antibody titres (rho 0.423, p < 0.001) and anti-N antibody titres (rho = 0.55, p < 0.0001).ConclusionHigh sensitivity, specificity, and PPV were demonstrated for the POC LFA for the detection of anti-S-RBD antibodies in comparison to the commercial assay. The LFA was not a reliable determinant of the neutralisation capacity of identified antibodies. POC LFA are useful tools in sero-epidemiology settings, pandemic preparedness and may act as supportive tools in treatment decisions through the rapid identification of anti-Spike antibodies.

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Development and Evaluation of a Point-of-Care Test in a Low-Resource Setting with High Rates of Chlamydia trachomatis Urogenital Infections in Fiji

Cited by 9 publications

References 35 publications

Prevalence of Mycoplasma genitalium and other sexually transmitted pathogens in male urethritis in a sexual health centre in New Caledonia

Prevalence of Mycoplasma genitalium and other sexually transmitted pathogens in male urethritis in a sexual health centre in New Caledonia

Nanoparticle-Based Lateral Flow Biosensor Integrated With Loop-Mediated Isothermal Amplification for Rapid and Visual Identification of Chlamydia trachomatis for Point-of-Care Use

Point of care detection of SARS-CoV-2 antibodies and neutralisation capacity—lateral flow immunoassay evaluation compared to commercial assay to inform potential role in therapeutic and surveillance practices

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