None listed
Conditions
Interventions
Intervention1: PregaNews-6 Days Sooner: Total duration will be 30 days.
To determine the analytical sensitivity cut off value of the hCG urine test using hCG
standards from 0 to 20 mIU per mL. Analy
Sponsors
Mankind Pharma Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male and non-pregnant females aged 18 years to 45 years at the time of consent. 2. Able and willing to provide written informed consent prior to any study-related procedure. 3. Capable of providing at least 200 mL of midstream urine in a sterile collection container. 4. Participants who fail screening will not undergo sample collection. 5. Willing to comply with sample collection procedures and study requirements.
Exclusion criteria
Exclusion criteria: 1. Use of any medication or therapeutic agent containing hCG within the past 30 days. 2. Presence of visible contamination in urine (e.g., blood, feces, excessive mucus, or other impurities). 3. Confirmed urinary tract infection or any condition that may impact urine quality, as per self-report. 4. Inability or unwillingness to comply with the sample collection requirements. 5. Any condition that, in the opinion of the investigator, may interfere with safe participation or sample integrity. 6. Volunteers, in the opinion of investigator, deemed unfit for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess sensitivity and precision of Preganews 06 days sooner kit for detection of B HCG at concentration of 10 mIU/mL in urine sampleTimepoint: In this study baseline would be B-HCG levels at 0 mIU per mL and treatment phase will be at 5, 7.5, 8, 9, 10, 15, 20 mIU per mL. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To assess specificity & cross reactivity Preganews 06 days sooner kit for detection of B HCG at concentration of 10 mIU/mL in urine sample - To compare the results from Preganews 06 days sooner kit with predicate deviceTimepoint: baseline for cross-reactivity with LH is 250 & follow up is at 500 & 1000 IU/mL), Baseline for FSH is 250 & follow up is 500 & 1000 mIU/mL, & for TSH baseline is 250 & follow up is 500 & 1000 IU/mL. To evaluate interference from common exogenous & endogenous substances in 0, 10, & 100 mIU/mL hCG samples. To verify consistent test line intensity & qualitative result accuracy. To compare the results with predicate device. | — |
Countries
India
Contacts
Public ContactMr Sandeep Yadav
Mankind Pharma Limited
Outcome results
None listed