Effect of reagent batch on activated partial thromboplastin time in canine plasma and use of the ratio system for standardization

In order to test the variability of the results of the activated partial thromboplastin time (APTT) in different reagent batches, 40 samples (20 from healthy dogs, 15 from patients with prolonged APTT as a result of different congenital or acquired haemostasis disorders, 5 from healthy dogs after in vitro addition of heparin) were used to compare 6 different lot Nos. of two commercial APTT-reagents (Pathromtin, PTT Reagent). Although the Friedman test showed a reagent batch dependency (p < 0.0001) for both reagents, only minor quantitative differences were observed with a variation coefficient of 2.7% (Pathromtin) and 2.4% (PTT Reagent), respectively. A second experiment was based on 105 samples measured with two batches of a third reagent (APTT-FS) with remarkable differences of results. Convergence of the results was achieved by converting into ratio values (quotient measurement value/control). However, statistical comparison still showed a significant difference. The study shows the good reproducibility of the APTT measured with different batches of the reagents Pathromtin and PTT Reagent in canine plasma, indicating that standardization is unnecessary. A standardization based on the ratio system can be used for reagents with a low batch consistency, requiring a high-quality control.