Trichomonas vaginalis – Antigen detection – Shipped 04 April 2016
TR1604-1: Negative TR1604-2: Negative TR1604-3: Positive TR1604-4: Positive
Suitability for grading
A challenge is considered suitable for grading if agreement is reached by 80 percent of selected reference group and at least 70 percent of the participants.
Trichomonas antigen determination was correctly performed by 3/3 reference laboratories and greater than 70 percent of all laboratories and was thus, determined to be suitable for grading.
The samples are assessed for homogeneity and stability using in-house quality control methods and random selection of samples before and during production, and post sample delivery. The number of random samples selected is based on selection tables within Military standard 105E (1).
The challenge sample lot was confirmed to be homogeneous and stable for at least 15 days.
Grading of Trichomonas vaginalis antigen is based on a Positive / Negative result, no further statistical analysis is performed on the results beyond that described under “Suitability for grading.”
(1) Famum NR. Acceptance sampling. In: Modern Statistical Quality Control and Improvement. Belmont, California.: Duxbury Press; 1994:305.