Clinical Trial of BioPoint ALT-1 Test

Clinical trial of the clinical significance research on BioPoint ALT-1 test for the rapid diagnostic product

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR1900024213

Enrollment

Unknown

Registered

2019-06-30

Start date

2019-08-01

Completion date

Unknown

Last updated

2019-07-01

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

Conditions

Liver diseases

Interventions

Gold Standard:Rate assay of clinical laboratory of Jiangsu Province Hospital (the kit does not contain pyridoxal phosphate)

Index test:BioPoint ALT-1 test

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) The age range is 18-79 years old; (2) Patients with liver diseases confirmedly or primarily diagnosed; (3) Understand the clinical trial and sign the informed consent; (4) Liver function test (liver biochemistry test) is conducted during this clinical trial; (5) Be able to complete the questionnaire survey of this clinical trial.

Exclusion criteria

Exclusion criteria: (1) Women during pregnancy or lactation; (2) Suffer from serious diseases other than liver diseases; (3) Recent hospitalization for surgery, blood donation, blood transfusion or massive blood loss.

Design outcomes

Primary

Measure	Time frame
Sensitivity;Specificity;Interclass correlation coefficient;Kappa;Linear correlation coefficient;Linear regression coefficient;cut-off value;	—

Secondary

Measure	Time frame
agreement rate;Positive predictive value;Negative predictive value;area under the curve;	—

Countries

China

Contacts

Public ContactCui Fuqiang

Peking University Health Science Center

cuifuq@126.com+86 13718891696

Outcome results

None listed

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