ELISPOT assay using induced sputum

Enzyme-linked immunospot assay using induced sputum for a rapid diagnosis of smear negative pulmonary tuberculosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0000376

Enrollment

Registered

2012-03-02

Start date

2010-06-10

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Others : Sputum induction Sputum induction is performed using 3% hypertonic saline solution generated by an ultrasonic nebulizer (Devilbiss Ultraneb 99

Sunrise Medical, PA, USA) for 20 minutes in a room with negative-pressure ventilation. All subjects are premeditated with 200 µg salbutamol via metered-dose inhaler 30 minutes prior to sputum inductio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) more than 18 years old 2) radiological evidence of pulmonary tuberculosis on plain chest X-ray 3) Subjects being investigated for pulmonary TB who were either at least 2 consecutive sputum acid fast bacilli (AFB) smear-negative or not producing sputum spontaneously

Exclusion criteria

Exclusion criteria: 1) less than 18 years 2) pregnancy

Design outcomes

Primary

Measure	Time frame
Difference of number of spot forming cells on ELISPOT assay between TB and non-TB group	—

Secondary

Measure	Time frame
Difference of number of spot forming cells between smear positive and smear negative TB group	—

Countries

Korea, Republic of

Contacts

Public ContactDoosoo Jeon

Pusan National University Yangsan Hospital

Outcome results