Suggestions(5)
Exact(2)
In the control group, anti-CS antibody GMTs were below the assay cut off (0.5 EU/mL) at all post vaccination time points.
This sample showed a very weakly positive signal after MDA treatment, suggesting that the amount of viral NA was close to the assay cut off.
Similar(58)
Key details of population (age, sex, country, race, year), diabetes (definition of diabetes, treatment, subgroups), reference standard (type of sample, stimulation, assay, cut-off used) and clinical predictors (which predictors were included, how they were measured, the cut-offs used) were recorded.
Confirmatory assay parameters that contribute to this disagreement include differences in antigen selection (full length LEDGF vs. major antigenic region), recombinant expression system used for antigen production (E. coli vs. Baculo virus system vs. mammalian cells), analytical sensitivity/specificity of the various assay platforms and the established assay cut-off.
Following the selection of each assay cut-off, assay sensitivity was evaluated using a total of 302 samples with sequence-detectable drug resistance mutations.
This calculation is termed the Assay Cut-off and is graphed as a horizontal line along the bar graph for simplicity of presentation and interpretation.
The avidity assay was performed as previously described [6], [9], except that an assay cut-off of 40% was used for recent infection.
Subjects with antibody response≥the assay cut-off were considered protected against Hib-disease, diphtheria, tetanus or hepatitis B. To cope with the multiplicity of study objectives, the pre-set criteria for meeting the study objectives were assessed sequentially.
The BED assay was performed according to the manufacturer's instructions (Calypte Biomedical Corporation, Lake Oswego, OR, USA), using an assay cut-off of 0.8 normalized optical density units (OD-n) for recent infection (3).
Antibody titres were measured against hepatitis B surface antigen (anti-HBs) and P. falciparum circumsporozoite protein (anti-CS) at screening and 1, 3½ and 12 months post dose 3. Anti-CS antibodies were measured by a standardized ELISA, using plates absorbed with recombinant R32LR with an assay cut-off of 0.5 EU/mL.
The assay cut-off was 1 8.
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