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Advanced Techniques in Diagnostic Microbiology

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TABLE 2.1. Comparison of 13 C-urea breath tests for H. pylori based on <strong>in</strong>formation at manufacturers’ Web sites.<br />

Test name FDA status Fast<strong>in</strong>g Detection Sample collection time Instrument time Sensitivity a Specificity a Manufacturer<br />

BreathTek IVD b 1 h GIRMS, or 0 and 15 m<strong>in</strong> Sent to specialty lab (GIRMS) 95% 95% Mereteck<br />

UBiT-IR300 5.5 m<strong>in</strong> (UBiT-IR300)<br />

Helikit IVD b 4 h IRMS, or 30 m<strong>in</strong> Sent to specialty lab (IRMS) 98% 95% Isodiagnostika<br />

ISOMAX 2002 not available (ISOMAX)<br />

a Based on statements <strong>in</strong> manufacturers’ product <strong>in</strong>serts.<br />

b For <strong>in</strong> vitro diagnostic use.<br />

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