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A Study on the Consistency Evaluation of Digital PCR Technology for Quantitative Detection of HBV Nucleic Acid

3. juli 2026 oppdatert av: Minghui Li, Beijing Municipal Administration of Hospitals

A Study on the Consistency Evaluation of Digital PCR Technology for Quantitative Detection of Hepatitis B Virus Nucleic Acid

The research plan aims to evaluate the consistency of the digital PCR-based hepatitis B virus nucleic acid quantification technique with the existing Roche qPCR-based detection method. Approximately 200 samples of residual serum from patients with chronic hepatitis B, covering high, medium, low, and those below the Roche lower limit concentration or undetectable, will be collected. The two methods will be used for parallel testing. The main objective is to evaluate the quantitative consistency of the two methods within the quantifiable range of Roche (≥ 20 IU/mL); the secondary objectives include evaluating the qualitative detection rate of samples with concentrations below 20 IU/mL or undetectable nucleic acid.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The study aims to include a total sample size of approximately 200 cases: 100 positive cases: ≥ 1000 IU/mL: 40 cases; 100 - 1000 IU/mL: 30 cases; 20 - 100 IU/mL: 30 cases; 100 negative cases: lower than 20 IU/mL: 40 cases, and undetected: 60 cases. Collect the age, gender, duration of HBV infection, antiviral treatment drugs and treatment courses, HBeAg status, HBsAg quantification (if available), ALT/AST levels, date of blood sample collection, date and result of combas HBV DNA detection, and digital PCR detection results of the enrolled patients. By comparing the detection results of the two methods, evaluate the quantitative accuracy or qualitative detection ability of the digital PCR hepatitis B detection method.

Studietype

Observasjonsmessig

Registrering (Antatt)

200

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100015
        • Beijing Ditan Hospital, Capital Medical University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

The research samples were derived from the routine diagnostic leftover serum samples of chronic hepatitis B patients who were treated at the outpatient or inpatient departments of Beijing Ditan Hospital, Capital Medical University. All the samples were the leftover samples obtained after the routine HBV DNA testing (combas HBV) was completed, and they were the secondary utilization of the leftover samples from clinical routine tests.

Beskrivelse

Inclusion Criteria:

  1. Patients who have been diagnosed with chronic hepatitis B (in accordance with the diagnostic criteria of the "Chronic Hepatitis B Prevention and Treatment Guidelines (2022 Edition)") and are currently receiving NAs antiviral treatment for ≥ 6 months or have not received treatment and are ≥ 18 years old;
  2. Remaining samples (serum) that have undergone combas HBV DNA testing and have clear test results, with the sample collection time frozen for ≤ 6 months;
  3. The remaining sample volume is sufficient (≥ 1.0 mL), sufficient for digital PCR testing and necessary duplicate testing;
  4. Samples from the same patient at different time points can be included as independent samples, but the sampling interval time needs to be recorded.

Exclusion Criteria:

  1. Combine other liver virus infections such as HCV, HDV or HIV;
  2. Poor sample quality, such as severe hemolysis, lipemia or repeated freezing and thawing ≥ 3 times;
  3. The samples were not properly frozen and stored (-80℃) after collection or the temperature records were missing;
  4. The clinical information is severely lacking, making it impossible to confirm the diagnosis and treatment status;
  5. The duplicate samples already included at the same time point (only the first included sample is retained).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
High-concentration group
After detection using digital PCR technology, the results were classified according to concentration levels as follows: high concentration group (≥ 1000 IU/mL); medium concentration group (100 - 1000 IU/mL); low concentration group (20 - 100 IU/mL); extremely low concentration group (below 20 IU/mL); undetectable group.
Annen: the results were classified according to concentration levels
the results were classified according to concentration levels
medium concentration group
After detection using digital PCR technology, the results were classified according to concentration levels as follows: high concentration group (≥ 1000 IU/mL); medium concentration group (100 - 1000 IU/mL); low concentration group (20 - 100 IU/mL); extremely low concentration group (below 20 IU/mL); undetectable group.
Annen: the results were classified according to concentration levels
the results were classified according to concentration levels
low concentration group
After detection using digital PCR technology, the results were classified according to concentration levels as follows: high concentration group (≥ 1000 IU/mL); medium concentration group (100 - 1000 IU/mL); low concentration group (20 - 100 IU/mL); extremely low concentration group (below 20 IU/mL); undetectable group.
Annen: the results were classified according to concentration levels
the results were classified according to concentration levels
extremely low concentration group
After detection using digital PCR technology, the results were classified according to concentration levels as follows: high concentration group (≥ 1000 IU/mL); medium concentration group (100 - 1000 IU/mL); low concentration group (20 - 100 IU/mL); extremely low concentration group (below 20 IU/mL); undetectable group.
Annen: the results were classified according to concentration levels
the results were classified according to concentration levels
undetectable group
After detection using digital PCR technology, the results were classified according to concentration levels as follows: high concentration group (≥ 1000 IU/mL); medium concentration group (100 - 1000 IU/mL); low concentration group (20 - 100 IU/mL); extremely low concentration group (below 20 IU/mL); undetectable group.
Annen: the results were classified according to concentration levels
the results were classified according to concentration levels

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
quantitative consistency
Tidsramme: "Baseline, single cross-sectional testing at sample collection, through study completion"
Evaluate the quantitative consistency of the self-developed digital PCR (ddPCR) method with the Roche Cobas TaqMan HBV DNA test (cobas HBV) within the quantifiable range (≥ 20 IU/mL)
"Baseline, single cross-sectional testing at sample collection, through study completion"

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Beijing Municipal Administration of Hospitals

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. august 2026

Primær fullføring (Antatt)

1. august 2028

Studiet fullført (Antatt)

1. august 2028

Datoer for studieregistrering

Først innsendt

29. juni 2026

Først innsendt som oppfylte QC-kriteriene

29. juni 2026

Først lagt ut (Faktiske)

6. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • DTEC-KY2026-075-01

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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