Health Condition 1: B970- Adenovirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: DEN-LAMP KIT: Molecular Diagnostic Accuracy and Novel Detection of Dengue Virus Using an NS2 Gene Based Reverse Transcription Loop-Mediated Isothermal Amplification Assay in 1 year dura
Sponsors
RUBINA MARY
Eligibility
Inclusion criteria
Inclusion criteria: Clinically suspected dengue patients of both genders aged 0 to 65 years, as identified and referred by clinicians for laboratory investigation. Written informed consent will be obtained from participants aged above 18 years. For participants aged less than 18 years, written informed consent from parents or legally authorized guardians will be obtained, with assent from the child wherever applicable
Exclusion criteria
Exclusion criteria: Unsuspected Dengue patients and participants who could not provide informed consent will be excluded from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the diagnostic accuracy of the NS2 gene based RT-LAMP assay (DEN-LAMP) for detection of dengue virus in clinically suspected dengue patients, as measured by sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), using conventional RT-PCR as the reference standard.Timepoint: Baseline (0 7 days from fever onset) Primary outcome (sensitivity,specificity,PPV,NPV) assessed using samples collected during the acute febrile phase (within 7 days of symptom onset), with DEN-LAMP compared against RT-PCR | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the time to detection of dengue virus using the DEN-LAMP assay with conventional RT-PCR and assess its turnaround time. To evaluate the analytical and operational performance of DEN-LAMP, including limit of detection, reproducibility, and ease of use in a routine laboratory setting. To compare the cost per test and assess the agreement between DEN-LAMP and RT-PCR results using appropriate statistical measures (e.g., kappa statistic)Timepoint: secondary outcomes will be assessed at baseline (Day 0 1) during laboratory processing of the same clinical specimen and throughout the study period for analytical performance parameters (limit of detection and reproducibility). | — |
Countries
India
Contacts
Public ContactDr Rubina Mary
Saveetha Medical College and Hospital
Outcome results
None listed