ABO Blood Type, RhD Blood Type
Conditions
Brief summary
CLS-019A is a prospective, multi-site, parallel clinical performance study. Each enrolled subject is tested on both investigational devices in parallel within a single study visit, yielding paired INSTI® and TruPlex results from matched capillary fingerstick and EDTA-VWB samples.
Interventions
DIAGNOSTIC_TESTINSTI® Rapid Blood Type Test
A flow-through blood grouping reagent device intended for the determination of ABO and RhD blood group by forward typing using human whole blood samples.
DIAGNOSTIC_TESTTruPlex Rapid Blood Type Test
A lateral-flow blood grouping reagent device intended for the determination of ABO and RhD blood group by forward typing using human whole blood samples.
Sponsors
bioLytical Laboratories
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Subjects will be enrolled in the Main Cohort if they meet all of criteria IC.1 through IC.6. Subjects will be enrolled in the Rare-Phenotype Cohort if they meet all of criteria IC.1 through IC.7: 1. Subject is 18 years of age or older at the time of enrollment. 2. Subject is able to provide written informed consent prior to any study-related procedures. 3. Operator or study staff is able to obtain required data to complete the subject's Enrollment Questionnaire. 4. Subject is able and willing to complete all required study procedures on the allocated testing day. 5. Subjects is able to speak/read/write in English or Spanish. 6. Subjects is willing to provide: * Two (2) capillary fingerstick whole blood samples, and * Venous whole blood samples collected by venipuncture (approximately 10 mL), as required for the study. And * If required, a maximum of two (2) further fingerstick whole blood samples in the case that the initial INSTI and/or TruPlex test results are invalid. Additional Inclusion Criterion for Rare-Phenotype Cohort Enrollment: 7. Subject has a previously documented rare ABO subgroup or RhD variant phenotype.
Exclusion criteria
Subjects will be excluded from the study if they meet any of the following criteria: 1. Subject has known bleeding disorder or any other medical condition that, in the opinion of the Investigator or Operator, contraindicates fingerstick or venipuncture. 2. Subject has received a blood transfusion within the past 120 days. 3. Subject is currently using therapeutic anticoagulants (e.g., warfarin, heparin, or direct oral anticoagulants \[DOACs\]) that, in the opinion of the Investigator or Operator, may interfere with sample collection or test performance. 4. Subject has any condition which, in the opinion of the Investigator or Operator, would: * Place the participant at undue risk, * Interfere with completion of study procedures, * Compromise the informed consent process, or * Bias the interpretation of study results. Examples include, but are not limited to: intoxication, acute illness, visible distress, or inability to understand study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical performance of the INSTI® and TruPlex Rapid Blood Typing Tests for ABO (A, B, AB, and O) and RhD blood type detection | 6 months | To evaluate the clinical performance (PPA and NPA) of the INSTI® and TruPlex Rapid Blood Typing Tests for ABO (A, B, AB, and O) and RhD blood types through detection of A, B, and RhD antigens using both capillary fingerstick and EDTA venous whole blood (VWB) samples. Performance will be determined by comparing the results of each investigational device with reference tests for ABO and RhD status. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| INSTI® and TruPlex Rapid Blood Typing Test Invalid Rate | 6 months | To monitor and report the rate of invalid test results for the INSTI® and TruPlex Rapid Blood Typing Tests. |
Contacts
CONTACTPatrick Diaz
CONTACTAna Subramanian
Outcome results
None listed