Factor Theory
Regulatory Guidelines
Reg Guidlines cont.
Factor Curves
Factor Setup in SCE
200

Factors VIII, IX, XI,XII,are in this pathway of the coagulation cascade.

What is the Intrinsic pathway?

200

Cause for rejection when transporting samples for Factor Assay testing on ice.

What is activating Factor VII and loss of vWF.

200

Recommended concentrations for deficient plasma reagents include a certain minimum percentage of the Factor being tested and of the other Factors. 

What is < 1% for testing Factor and all other Factors > 50%

200

Name the three types of calibration curves used in Factor Assays.

What are linear, polynomial, and low curves?

200

In the SCE this test calculates the mean of the 1/10, 1/20 and 1/40 dilutions for Factor 8.

What is the F8M?

400

These pathways in the coagulation cascade includes Factors II, V, VII and X

What is the Extrinsic and Common pathways?

400

CLSI recommendation for thawing frozen samples for Factor Assays 

What is a rapid thaw in 37 degree waterbath, 5min/ml?

400

When raw data values exceeds the limits of the curve.

What is an extrapolated value.

400

True or False?  The low curve calibrator value must be manually calculated and entered into the Instrument software.

What is False?

400

Remember this instrument setting in the Factor methodology may need to be adjusted when using SCE Factor Rules.

What is remove auto redilute conditions from setup on analyzer.

600

The mixture of a diluted sample with a deficient plasma with a single step of recalcification leading to clot formation is known as 

What is a one-stage Clotting Factor Assay?

600

This cutoff is used to determine the sensitivity of the PT and PTT reagents in Factor Assay testing when the PT and PTT results are prolonged.

What is < 30% activity?

600

This requirement proves the validity of the Factor assay when the patient sample and calibrator both behave in a similar way under the same test conditions.

What is Parallelism?

600

This statistical value of a calibration curve represents how well points fall on the curve.

What is the R value?

600

In the SCE, this is where you can set up a battery of tests to run Factor dilutions. Example, 1/10, 1/20, 1/40.

What is in the General Tab of The Test?

800

 To diagnosis patients presenting with a prolonged PT or PTT to rule out common conditions such as deficiencies ,inhibitors or persistent hereditary evaluation ( requires confirmation by family studies) that may predispose a patient to thrombosis.

When to perform a Factor Assay?

800

In Factor testing, this number of sample dilutions is recommended to rule out inhibitors and improve precision of the assay.

What is 3 dilutions?

800

This methodology makes Factor assays exempt from CAP AMR verification. 

What is clot based?

800

Given the results of the calibration points a line is drawn that connects each individual point.

What is a polynomial curve?

800

This Factor test in the SCE is used to send the final result to the LIS when using Factor rules.

What is the Roman numeral test?

1000

Although these coagulation proteins do not cause bleeding their activity can be tested using a PTT based Factor Assay

What are HMW Kininogen and Prekallikrein?

1000

This Factor Inhibitor inhibits complete factor activity.

What is Type I Inhibitor or Alloantibodies?

1000

These Inhibitors can inhibit partial factor activity or can present as nonparallelism.

What is Lupus Anticoagulant and Anticoagulants?

1000

The set of operations that establish under specified conditions, the relationship between reagent/instrument system response and the corresponding concentration/activity values of an analyte.

What is a calibration?

1000

This is where the tests are pulled from the SCE database.

What is Paramsinstall?

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