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PTT Test

PTT Test

The Partial Thromboplastin Time (PTT) test is a general screening test for the detection of coagulation abnormalities in the intrinsic pathway. This test is performed on devices/materials that have direct contact with circulating blood.

Download the biocompatibility test matrix. [Based on ISO 10993-1:2010 (E) and FDA G95-1 Guidelines]

Applicable Standards

  • ANSI/AAMI/ISO 10993-4
  • ANSI/AAMI/ISO 10993-12

Test Options

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product. If you are ready to submit your samples for testing, click here to fill out the Sample Submission Form.

Code Test TAT (days) Request Quote
HCX220 Hemocompatibility: Partial Thromboplastin Time (PTT), Human plasma 14 Add
HCX225 Hemocompatibility: Partial Thromboplastin Time (PTT), Human plasma, test & predicate 14 Add
HCX220 - Hemocompatibility: Partial Thromboplastin Time (PTT), Human plasma
TAT: 14 days
HCX225 - Hemocompatibility: Partial Thromboplastin Time (PTT), Human plasma, test & predicate
TAT: 14 days

Sample Specifications

HCX220: 1 device or 12-24 cm2
HCX225: 1 device or 12-24 cm2 each (test article & predicate)

Study Outline

The Partial Thromboplastin Time (PTT) assay was developed from the plasma recalcification and uses a PTT reagent as a platelet substitute. The sample is exposed to citrated plasma for 60 minutes at a validated temperature. The exposed plasma is divided into six replicates and incubated at 37 ± 1°C for 3 minutes.

The PTT reagent is then added followed by the addition of a calcium chloride solution which inactivates the anticoagulant and allows a clot to form. The amount of time elapsed prior to the clot formation is monitored and recorded. Evaluation of the clotting times is performed using statistical comparisons to the controls.

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