Health Condition 1: B20- Human immunodeficiency virus [HIV]disease Health Condition 2: B169- Acute hepatitis B without delta-agent and without hepatic coma Health Condition 3: A530- Latent syphilis, unspecified as early or late
Conditions
Interventions
Control Intervention1: HBsAg Rapid Test Cassette: HANGZHOU ALLTEST BIOTECH CO. LTD, The HBsAg Rapid Test Cassette is a rapid chromatographic
immunoassay for the qualitative detection of Hepatitis B S
Sponsors
Cupid Limited
Eligibility
Inclusion criteria
Inclusion criteria: HIV-1 Positive Subjects: Confirmed diagnosis of HIV-1 infection, including 40 non-B-subtypes all available HIV/1 subtypes shall be represented by at least 3 specimens per subtype. HIV-2 Positive Subjects: Confirmed diagnosis of HIV-2 infection, including 40 non-B-subtypes HBsAg Positive Subjects: Confirmed diagnosis of Hepatitis B infection, including evaluation of different HBV markers such as genotypes, subtypes, or mutants. Syphilis Positive subjects: Confirmed diagnosis of Syphilis infection, across different stages if available, including high and low positive specimens identified by at least two different serological tests (one of which is an enzyme immunoassay) for antibodies to T. pallidum. Pregnant Women: Confirmed pregnancy. Rheumatoid Factor & Other cross-reacting agents: Confirmed diagnosis of Rheumatoid Factor and, related infections Hospitalized Subjects: Currently hospitalized for any condition. Unselected Blood Donors: Individuals who have donated blood (Including first time donors).
Exclusion criteria
Exclusion criteria: General Exclusions: Inability or unwillingness to provide informed consent. Specific Exclusions: For HIV-1 and HIV-2 Positive subjects: Co-infection with other significant infectious diseases (e.g., Hepatitis B or C). For HBsAg Positive subjects: Co-morbid conditions with other chronic viral infections (e.g., HIV). For Syphilis Positive subjects: Co-morbid conditions with other severe chronic conditions (e.g., severe cardiac, renal, hepatic issues). For Pregnant Women: High-risk pregnancy conditions that may interfere with study participation. For Rheumatoid Factor and Other cross-reacting agents: Concurrent participation in another clinical study that may interfere with study outcomes. For Hospitalized Subjects: Conditions that may compromise the safety of the participant or the integrity of the study data. For Unselected Blood Donors: Recent history of blood transfusion or donation within the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analytical sensitivity Analytical specificity and cross-reactivity Diagnostic sensitivity and Positive predictive value Diagnostic specificity and Negative predictive value Hook effect Precision (repeatability and reproducibility) Validation of reading timeTimepoint: At Baseline Visit (Single Visit) | — |
Secondary
| Measure | Time frame |
|---|---|
| NA (There is no impact on patients)Timepoint: NA | — |
Countries
India
Contacts
Public ContactSharad Babasaheb Pangarkar
CUPID LIMITED
Outcome results
None listed