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Construction of transient amplification strategy and its application in low-cost rapid detection of infectious diseases

Construction of transient amplification strategy and its application in low-cost rapid detection of infectious diseases

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114405
Enrollment
Unknown
Registered
2025-12-11
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ureaplasma urealyticum infection, Chlamydia trachomatis infection, Neisseria gonorrhoeae infection, Mycoplasma genitalium infection, Ureaplasma parvum infection, Mycobacterium tuberculosis infection, Enterovirus infection, Mycoplasma pneumoniae infection, Aspergillus infection, Cryptococcus neoformans infection, Rubella virus infection, Novel coronavirus infection, Influenza virus infection.

Interventions

The observation group included 30 paired samples for each of the following: genital swabs and matched urine from patients with Ureaplasma urealyticum infection (n=30), Chlamydia trachomatis infection
genital swabs from patients with Ureaplasma parvum infection (n=30)
sputum from patients with Mycobacterium tuberculosis infection (n=30)
nasal swabs from patients with enterovirus infection (n=30), Mycoplasma pneumoniae infection (n=30), Aspergillus species infection (n=30), and Cryptococcus neoformans infection (n=30)
plasma from patients with rubella virus infection (n=30)
nasal swabs and matched plasma from patients with SARS-CoV-2 infection (n=30) and influenza virus infection (n=30)
and matched nasal swabs, genital swabs, sputum, plasma, and urine from 30 healthy controls.:None

Sponsors

Southern Medical University Southern Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Patient inclusion criteria: ( 1 ) Age >= 18, male or female ; ( 2 ) Voluntary signing of informed consent ;(3) Patients diagnosed with Ureaplasma urealyticum infection through the "Ureaplasma urealyticum nucleic acid detection kit", patients diagnosed with Chlamydia trachomatis infection through the "Diagnosis of Chlamydia trachomatis infection in the reproductive tract" on pages 5 and 12 of the "Diagnosis of gonorrhea", patients diagnosed with Neisseria gonorrhoeae infection through the "Diagnosis of Gonorrhea", patients diagnosed with Mycoplasma genitalium infection through the "Chinese Consensus on Diagnosis and Treatment of Mycoplasma genitalium infection (2024)", patients diagnosed with Mycoplasma genitalium infection through the "Ureaplasma/Human type Mycoplasma culture and drug sensitivity detection kit", patients diagnosed with Mycobacterium tuberculosis infection through the "Diagnostic Standards for Tuberculosis", patients diagnosed with Enterovirus 71 (EV71 virus) real-time fluorescent RT-PCR through the "Border Port Enterovirus 71 (EV71 virus) The sentence is: Patients diagnosed as enterovirus infection by the Test Method, patients diagnosed as mycoplasma pneumonia infection by the Mycoplasma Pneumoniae Antibody Test Kit, patients diagnosed as aspergillus infection by the Expert Consensus on the Clinical Application of Laboratory Diagnosis of Invasive Mycosis (2024 Edition), patients diagnosed as cryptococcus neoformans infection by the Global Guidelines for the Diagnosis and Management of Cryptococcosis: ECMM-ISHAM-ASM Cooperative Initiative, patients diagnosed as rubella virus infection by the Rubella Diagnostic Criteria, patients diagnosed as COVID-19 infection by the Diagnosis and Treatment Plan for novel coronavirus Infection (Tenth Edition for Trial Implementation), and patients diagnosed as influenza Diagnosis and Treatment Plan (2025 Edition)) Patients diagnosed with influenza virus infection; (4) Not receiving any treatment; (5) No mental illness, able to understand and communicate normally. 2. Selection criteria for healthy volunteers: (1) Age>= 18, regardless of gender; (2) Voluntary signing of informed consent form; (3) Normal individuals diagnosed with no underlying diseases or tumors through examination at Southern Hospital, including normal liver function, normal electrocardiogram, normal tumor markers, and normal blood routine tests.

Exclusion criteria

Exclusion criteria: 1. Exclusion criteria for patients: (1) Severe organ dysfunction; (2) Cases with incomplete subject information or incomplete collection due to other reasons; (3) According to the researcher's judgment, it is not suitable to participate in this study. 2. Exclusion criteria for healthy volunteers: (1) Having infectious diseases; (2) Cases with incomplete subject information or incomplete collection due to other reasons; (3) According to the researcher's judgment, it is not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Ribonucleic Acid;Diagnostic performance of Flash-CHA amplification strategy for infectious diseases;

Secondary

MeasureTime frame
Correlation between specimen RNA expression levels and the occurrence of infectious diseases;

Countries

China

Contacts

Public ContactZhang Ye

Southern Medical University Southern Hospital

Zhangye232@i.smu.edu.cn+86 15622126037

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026