Hyperparathyroidism, Parathyroid; Anomaly, Parathyroid Dysfunction, Parathyroid Gland Adenoma
Conditions
Keywords
Immunoassay Lateral Flow, Parathyroid gland, PTH, FNA, Parathyroid gland,, PTH,, FNA
Brief summary
STUDY PURPOSE The purpose of this study is to demonstrate the performance of the Parakeet Rapid Parathyroid Testing Kit by comparing Parakeet results with histopathologic Diagnosis. STUDY OBJECTIVES To demonstrate the positive percent agreement (PPA) and negative percent agreement (NPA) of the Parakeet Rapid Parathyroid Testing kit test results in FNA from excised tissue during parathyroid surgery with Pathologic Diagnosis.
Detailed description
The Parakeet is a lateral flow cassette designed to aid in the detection of parathyroid gland by identifying tissue with parathyroid hormone levels \> 60 pg./ml in a fine needle aspirate specimen. The FNA specimen of the target tissue is combined with running fluid and deposited into the sample well of a lateral flow cassette. Lateral flow occurs and the Test Line begins to darken within minutes if PTH is present in quantities \> 60 pg./ml. At 5 minutes, a full visualization of the TL is done. A negative test (\< 60 pg./ml of PTH in the sample) shows darkening of the Control Line only. Absence of Control Line development indicates a defective test kit. INTENDED USE The Parakeet Rapid Parathyroid Testing Kit is an immunoassay lateral flow cassette intended to detect qualitative differences in extracellular concentration of parathyroid hormone in excised samples suspected of being parathyroid glands as an adjunct to current clinical methods, including histopathology, to locate the parathyroid glands. INDICATIONS FOR USE The Parakeet Rapid Parathyroid Testing Kit is indicated for use in adult patients where location of the parathyroid glands is medically necessary, such as in patients undergoing parathyroidectomy for Hyperparathyroidism.
Interventions
DEVICEParakeet:The Parakeet Rapid Parathyroid Testing Kit is a rapid immunoassay designed to detect Parathormone (PTH) in a test sample.
The Parakeet Rapid Parathyroid Testing Kit is a rapid immunoassay designed to detect Parathormone (PTH) in a test sample. The Parakeet is a point of care test completely controlled by the surgeon and operating team. It uses the scientific principle of Lateral Flow of antibody-antigen-conjugate complexes being arrested in a Test Line.
Sponsors
Neurovision Medical Products Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Men and women ≥18 years of age Scheduled for Parathyroid surgery
Exclusion criteria
Unable or unwilling to provide informed consent Subject has any condition that in the opinion of the investigator should preclude participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The participant's IVD PTH concentration is < 57 pg/ml and the pathology report will be negative for parathyroid gland. The participant's IVD PTH concentration is > 57 pg/ml and the pathology report will be positive for parathyroid gland. | 5 minutes | PT ID (visual): Visual Reading for FNA only; Positive (indicates a PTG), Negative (non-PTG). Qualitative variable, if the sample demonstrates a Test Line visual development, it is Positive. If the Test Line does not demonstrate visual development this indicates less than the threshold of 60 pg./ml of PTH and it is considered negative (non-PTG) (Figure 5). The visual reading is by the tester and the surgeon is not notified. A faint or equivocal Test Line reading should be evaluated by the tester and repeated or other measures taken |
Countries
United States
Outcome results
None listed