Health Condition 1: R70-R79- Abnormal findings on examination of blood, without diagnosis
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Sponsors
SigTuple Technologies Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: The study is an all comers study that shall include samples from healthy individuals and samples from individuals with various hematological conditions and distributional abnormalities such as anemia, thrombocytopenia, leukopenia, leukocytosis, elevated hematocrit, elevated nucleated red blood cells, leukemia, etc. The abnormal samples shall align with the recommendations of the CLSI H20-A2 standard. Samples from both genders shall be used. Samples from individuals belonging to any race/ethnicity can be used.
Exclusion criteria
Exclusion criteria: The following sample exclusion criteria shall be applied - 1. Slides that are not prepared adequately shall be excluded from the study. For example slides that are not smeared well or are stained poorly. 2. Slides that have been prepared from degenerated blood and are considered unsuitable for evaluation by the qualified reviewers after examination under a light microscope (as per the standard procedures of the laboratory). 3. Slides considered unsuitable for evaluation by the qualified reviewers after examination under light microscope (as per the laboratory s standard procedures).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Agreement between AS76 with PBS and light microscopy in evaluating white blood cell (WBC), red blood cell (RBC), and platelet (PLT) morphologies. For WBCs: Passing-Bablok regression (slope, intercept, bias) will be used for differential counts. Sensitivity, specificity, and overall agreement will be calculated for detecting WBC abnormalities. For RBCs and PLTs: sensitivity, specificity, and overall agreement for morphological abnormalities. Timepoint: The outcomes will be analyzed 3 months from the date of study initiation. | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactTathagato Rai Dastidar
Sigtuple Technologies Private Limited
Outcome results
None listed