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1.
Sex Transm Dis ; 51(3): 186-191, 2024 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-38412465

RESUMO

BACKGROUND: Neisseria gonorrhoeae (NG) has acquired significant resistance, primarily due to extensive and unwarranted antibiotic utilization over several decades. This resistance has largely been associated with the syndromic management of sexually transmitted infections, particularly in low- and middle-income countries where affordable point of care tests are unavailable. To address this diagnostic gap, FIND has developed a low-cost lateral flow assay for the detection of NG at the point of care. METHODS: The early performance of the lateral flow assay was evaluated using frozen clinical samples. Limit of detection, inclusivity, and exclusivity studies were performed using well-characterized NG strains, common commensal genital microorganisms, and other Neisseria bacteria. Subsequently, clinical performance was evaluated at 2 sexual health clinics in Birmingham, Alabama. RESULTS: The observed limit of detection with reference NG strains was 5 × 103 CFU/mL. Inclusivity was demonstrated for 31 NG strains. Exclusivity testing showed no cross-reactivity with 28 non-Neisseria and nongonococcal Neisseria species; cross-reactivity was observed with Neisseria meningitidis, Neisseria lactamica, and Neisseria polysaccharea. The lateral flow assay demonstrated clinical sensitivity and specificity of 78.6% and 100% in female vaginal swabs and 100% and 89.7% in male urine, respectively. CONCLUSIONS: FIND has developed a lateral flow assay that aligns with the majority of the World Health Organization Target Product Profile criteria for confirming or excluding NG infection at the point of care. The NG lateral flow assay has now achieved design freeze (final device optimization) and is ready for technology transfer to a manufacturing partner. This test has the potential to support the shift in patient management from a syndromic to an etiological approach.


Assuntos
Infecções por Chlamydia , Gonorreia , Infecções Sexualmente Transmissíveis , Masculino , Feminino , Humanos , Neisseria gonorrhoeae , Sistemas Automatizados de Assistência Junto ao Leito , Infecções por Chlamydia/diagnóstico , Chlamydia trachomatis , Infecções Sexualmente Transmissíveis/diagnóstico , Gonorreia/diagnóstico , Gonorreia/microbiologia , Sensibilidade e Especificidade
2.
Sex Transm Dis ; 47(1): 67-69, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31856075

RESUMO

We examined the acceptability and feasibility of using a 30-minute chlamydia/gonorrhea test in a student health clinical setting. One hundred eight students were enrolled and 89.4% were willing to wait up to 20 minutes beyond the conclusion of their routine visit. The average amount of time added per clinic visit was less than 11 minutes. Patient and staff satisfaction were high.


Assuntos
Programas de Rastreamento/psicologia , Aceitação pelo Paciente de Cuidados de Saúde/psicologia , Infecções Sexualmente Transmissíveis/diagnóstico , Serviços de Saúde para Estudantes/estatística & dados numéricos , Estudantes/psicologia , Alabama , Infecções por Chlamydia/diagnóstico , Técnicas de Laboratório Clínico/estatística & dados numéricos , Gonorreia/diagnóstico , Humanos , Programas de Rastreamento/estatística & dados numéricos , Infecções Sexualmente Transmissíveis/microbiologia , Estudantes/estatística & dados numéricos , Fatores de Tempo
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