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Clinical Data

Determination of Expected Values and Precision for the Spectra™ APCT

A study was run to determine the normal range of the Spectra™ APCT test using platelet rich plasma, platelet poor plasma and platelet depleted plasma. The method used was the same as is in the Spectra™ APCT package insert.

 

Results of the study to set the normal ranges for Spectra™ APCT with platelet rich plasma were as follows:

 

Patient Information Mean Standard Deviation 95% Confidence Limits
Normal Range 46 normal patients 32.0 seconds +/- 4.4 seconds 23 - 40 seconds
Precision 1 normal patient (40 aliquots) 31.1 seconds +/- 0.457 seconds 30.2 - 32.0 seconds

Table 3. Normal values for Spectra™ APCT with platelet rich plasma fall between 23-40 seconds.

 

Since the normal ranges for the patented Spectra™ APCT for platelet rich plasma and APTT tests are very similar, it is easy to become acquainted with the Spectra™ APCT test. The instrument is the same; the techniques are similar. Running the Spectra™ APCT test instead of an APTT test as the first test for intrinsic system problems would enable the laboratorian to quickly increase the range of the laboratory's screening program.

ACS recommends running Spectra™ APCT with platelet poor plasma or platelet depleted plasma when extra sensitivity to the Lupus Anticoagulant or heparin therapy is needed. The normal ranges for platelet poor plasma and platelet depleted plasma are as follows:

  • Normal range PPP: 31.2-62.6 seconds
  • Normal range PDP: 73.3-115.7 seconds

When the Spectra™ APCT test is run with platelet poor plasma or platelet depleted plasma, the test is even more sensitive to the effects of the Lupus Anticoagulant. Since the diagnosis of Lupus Anticoagulant can be masked by the added phospholipid in APTT reagents, Spectra™ APCT's unique configuration is especially useful.

 

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