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The application of T/B cell antigen-treated shear ring (Trecs/Krecs) quantitative PCR detection in neonatal screening for primary immunodeficiency disease

The application of T/B cell antigen-treated shear ring (Trecs/Krecs) quantitative PCR detection in neonatal screening for primary immunodeficiency disease

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100043049
Enrollment
Unknown
Registered
2021-02-04
Start date
2021-02-04
Completion date
Unknown
Last updated
2021-05-24

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

Conditions

Severe combined immunodeficiency

Interventions

Gold Standard:TRECs: 40 copies / µ l whole blood Krecs: 40 copies / µ l whole blood RNase P: 2000 copies / µ l whole blood
detection&#32
of&#32
TRECs&#32
krecs&#32
and&#32
housekeeping&#32
gene&#32
plasmid&#32
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Sponsors

Chengdu Women's and Children's Center Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria of ganxue tablets: (1) The difference between the date of blood collection and the date of birth is less than or equal to 7 days, the blood card was made by collecting heel blood of newborn within 7 days after birth; (2) The difference between drilling date and blood collection date was less than 30 days; (3) Unlimited gestational age; (4) Unlimited production and weight.

Exclusion criteria

Exclusion criteria: Nil

Design outcomes

Primary

MeasureTime frame
TRECs PCR quantification;Krecs PCR quantitative analysis;positive predictive value, sensitivity, repetition rate, retest rate;

Secondary

MeasureTime frame
Quantitative analysis of housekeeping gene plasmid by PCR;

Countries

China

Contacts

Public ContactZhang wei

Chengdu Women's and Children's Center Hospital

gczhangwei@163.com+86 15388255245

Outcome results

None listed

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