Diagnosis of Respiratory Viruses in Children With Rhinoswab Junior
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 339
- 试验地点
- 2
- 主要终点
- Sensitivity of Rhinoswab compared with CTDN for 13 viruses on standard respiratory panel (Clinician collected/supervised)
研究概览
简要总结
A study to investigate Rhinoswab as an alternative method to combined throat and deep nasal (CTDN) swab for respiratory sample collection in children who present to the Royal Children's Hospital (RCH) for viral testing. Children and their parent/guardian will answer a short survey about their preferences. Laboratory staff will answer a short survey about handling the different samples.
详细描述
The microbiological test of choice for detection of respiratory viruses is a reverse transcription polymerase chain reaction (RT-PCR). The test is reported as "detected" or "not-detected" to the clinician. The Ct-value is a microbiological analysis that represents the number of amplification cycles required for a target gene to exceed a threshold level, to determine a negative or positive result and is interpreted to detect respiratory viruses. The Ct-value is used to measure viral load.
SARS-CoV-2, the virus that causes COVID-19, is a respiratory virus of specific interest. SARS-CoV-2 is detected in the upper respiratory tract. National guidelines for diagnosing COVID-19 in Australia require a combined throat and deep nasal swab (CTDN). No other testing options are routinely recommended in Australia. However, research and international guidelines recommend nasal swabs alone for SARS-CoV-2 detection. The Center for Disease Control and Prevention (USA) currently recommend the use of an anterior nasal swab alone as a method for detection of SARS-CoV-2. A recent systematic review suggested nasal swabs are a clinically acceptable alternative specimen collection methods. In addition to satisfactory diagnostic performance, nasal swabs are potentially less invasive, and can be self-collected.
Research at the Melbourne Children's Campus has identified that the CTDN or nasopharyngeal swab, are uncomfortable and distressing for children. The fear of the test is a barrier for presentation to a health service for a SARS-CoV-2 test. Parental and child reluctance to undergo testing may impact the public health response, through under-identification of pediatric cases.
The Rhinoswab is a TGA (Therapeutic Goods Administration) approved anterior nasal swab for children and adults. The design of the Rhinoswab allows for standardisation of the site of biological sampling, as compared with CTDN swabs which are operator dependent. It is designed to be more comfortable and to collect nasal secretions for PCR testing. The Rhinoswab Junior is a smaller paediatric version that has novelty features which add interest and distraction. The child can use the swab themselves, allowing autonomy and control. The capture and elution efficiency of the Rhinoswab has been shown to be comparable, if not slightly superior, to the capture and elution efficiency to the commercially available Copan eSwab by VIDRL (Victorian Infectious Diseases Reference Laboratory) and GNOMIX analyses.
The RCH has completed over 30,000 tests in children throughout the COVID-19 Pandemic from March 2020 to June 2021 at the Respiratory Infection Clinic and Emergency Department. The RCH nurses and doctors are well placed to trial the Rhinoswab due to extensive experience in testing children, and have developed related clinical practice guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Symptomatic and requiring a COVID-19 test at RCH or confirmed/suspected COVID-19 at home.
- •Aged between 1 month -18 years old.
- •Parent/guardian present.
- •Parents/self are able to provide consent.
排除标准
- •< 1 month or >18 years old.
- •Recent head or neck surgery
- •Inability (e.g. non-English speaking and if no interpreter is available) or unwillingness to consent
结局指标
主要结局
Sensitivity of Rhinoswab compared with CTDN for 13 viruses on standard respiratory panel (Clinician collected/supervised)
时间窗: 5 minutes from administering test
The results (detected/not detected) on all 13 viruses on the standard respiratory panel from both the Rhinoswab and the standard swabs will be obtained, and the sensitivity of the Rhinoswab compared to the CTDN determined. Sensitivity is calculated only in the participants who tested positive for the respective virus using the CTDN swab and is calculated as the proportion patients who tested positive on the Rhinoswab among those who tested positive on the CTDN swab. 95% confidence intervals will be calculated.
Specificity of Rhinoswab compared with CTDN for 13 viruses on standard respiratory panel (Clinician collected/supervised)
时间窗: 5 minutes from administering test
The results (detected/not detected) on all 13 viruses on the standard respiratory panel from both the Rhinoswab and the standard swabs will be obtained, and the specificity of the Rhinoswab compared to the CTDN determined. Specificity is calculated only in participants who tested negative for respiratory viruses and is calculated as the proportion patients who tested negative on Rhinoswab among those who tested negative on CTDN swab. 95% confidence intervals will be calculated.
次要结局
- Laboratory handling assessment(5 minutes for survey, to be completed up to 14 days post the last participant enrolled)
- Ct-Value of respiratory viruses on Rhinoswab compared with Ct-value of respiratory viruses on CTDN (Clinician-Collected/Supervised)(5 minutes from administering test)
- Specificity of Rhinoswab compared with CTDN for SARS-CoV-2 (Self-collected)(5 minutes from administering test)
- Swab Preference Assessment (Clinician-Collected/Supervised )(5 minutes from administering test)
- Median Ct-value of SARS-CoV-2 on Rhinoswab vs saliva vs CTDN (Self-collected)(5 minutes from administering test)
- Sensitivity of Rhinoswab compared with CTDN for SARS-CoV-2 (Self-collected)(5 minutes from administering test)
- Sensitivity of RAT compared with saliva for SARS-CoV-2 only (Self-collected)(15 minutes from administering test)
- Sensitivity of RAT compared to standard CTDN for SARS-CoV-2 only (Self-collected)(15 minutes from administering test)
- Comparison of RAT test (detected/not detected) to Ct-values for saliva and standard CTDN for SARS-CoV-2 only (Self-collected)(15 minutes from administering test)
