TABLE 1

Limits of detection of the plasma separation card for cobas HIVb

Concn (copies/ml)No. of valid samplesaNo. of reactive samplesDetection rate (%)
1,971.16262100.0
1,925.36363100.0
1,358.16262100.0
985.5636298.4
962.6636298.4
679635993.7
657635993.7
641.8635790.5
452.7635282.5
328.5634774.6
320.9634673.0
226.3624979.0
164.3633657.1
160.4633555.6
113.2633860.3
06300.0
06300.0
06300.0
  • a Some sample sizes were <63 due to an insufficient number of spots. Data for limit of detection analysis for CAP/CTM are not shown.

  • b Limit of detection by probit analysis (95% hit rate), 790.2 copies/ml. 95% confidence interval (CI), 658.9 to 1,003.6 copies/ml. Lowest panel member with ≥95% reactive rate, 962.6 copies/ml 98.4% (62/63); 95% CI = 91.5 to 100.0%; lower one-sided 95% CI = 92.7%.