Table 2.
Characteristics of the included studies that assessed the diagnostic test accuracy of the 14C-urea breath test
|
Ref.
|
Country
|
Design
|
Population, n
|
Prevalence (%)
|
Reference standard
|
Index test (model)
|
Optimal cut-off
|
Urea dosing (μCi)
|
Time after administration (min)
|
Measurement tecnique
|
TP
|
TN
|
FP
|
FN
|
| Han et al[30], 2023 | China | Cross-sectional | 205 | 42.4 | HE and RUT | 14C-UBT | 100 dpm | 0.75 | 20 | SC | 83 | 3 | 115 | 4 |
| Wang et al[29], 2021 | China | Cross-sectional | 267 | 71.9 | HE | 14C-UBT | 238 dpm | 0.75 | 25 | NR | 158 | 12 | 63 | 34 |
| Miftahussurur[69], 2021 | Indonesia | Cross-sectional | 55 | 23.6 | HE | 14C-UBT | 57 cpm | 1 | 10 | HA | 12 | 1 | 41 | 1 |
| Cosgun et al[70], 2016 | Turkey | Cross-sectional | 126 | 92.1 | HpC or HE | 14C-UBT | NR | 1 | 10 | HA | 112 | 7 | 3 | 4 |
| Atli et al[71], 2012 | Turkey | Cross-sectional | 100 | 35.0 | HE | 14C-UBT | Positive: > 50 cpm/suspicious: 25-50 cpm /negative: < 25 dpm | 1 | 10 | HA | 32 | 4 | 61 | 3 |
| Alarcón-Rivera et al[72], 2011 | Mexico | Cross-sectional | 84 | 70.2 | HE | 14C-UBT | Positive: > 50 ppm/indeterminate: 25-50 ppm/negative: < 25 ppm | 1 | 10-15 | HA | 56 | 1 | 24 | 3 |
| Mansour-Ghanaei et al[73], 2011 | Iran | Cross-sectional | 125 | 56.8 | HE, RUT, Serology (at least two positive) | 14C-UBT | 50 cpm | 1 | 15 | HA | 67 | 0 | 54 | 4 |
| Ozdemir et al[74], 2008 | Turkey | Cross-sectional | 89 | 66.3 | HE, RUT, PCR (at least two positive) | 14C-UBT | Positive: > 50 cpm/equivocal: 25-50 cpm; negative: < 25 dpm | 1 | 10 | HA | 57 | 0 | 30 | 2 |
| Rasool et al[75], 2007 | Pakistan | Cross-sectional | 94 | 64.9 | RUT | 14C-UBT | 50 cpm | 1 | 10 | β-SC | 60 | 3 | 30 | 1 |
| Gurbuz et al[76], 2005 | Turkey | Cross-sectional | 65 | 44.6 | HE | 14C-UBT | Positive: > 50 cpm/suspicious: 25-50 cpm /negative: < 25 dpm | 1 | 10 | HA | 26 | 8 | 28 | 3 |
| Gatta et al[31], 2003 | Italy | Cross-sectional | 117 | 65.0 | HpC or (HE and RUT) | 14C-UBT | 130-136 dpm (dpm at sample-dpm at T0) | 1 | 12.5 | LSC | 73 | 2 | 39 | 3 |
| González et al[77], 2003 | Chile | Cross-sectional | NR | 71.9 | Two or more positives | 14C-UBT | 200 dpm | 1 | 10 | LSC | 61 | 14 | 11 | 3 |
| Oztürk et al[78], 2009 | Turkey | Cross-sectional | 75 | 65.8 | HE | 14C-UBT | 100 dpm | 1 | 10 | LSC | 48 | 5 | 20 | 0 |
| Gomes et al[79], 2002 | Brazil | Cross-sectional | 137 | 83.9 | HE and RUT | 14C-UBT | 1000 cpm | 5 | 15 | LSC | 114 | 1 | 21 | 1 |
| Desroches et al[80], 1997 | Canada | Cross-sectional | 56 | 80.4 | HE or HpC | 14C-UBT | 0.33‰ AS (14CO2 specific activity) | 5 | 20 | LSC | 44 | 0 | 11 | 1 |
| Allardyce et al[81], 1997 | New Zealand | Cross-sectional | 63 | 34.9 | HE and RUT | 14C-UBT | 49 dpm | 1 | 30 | β-SC | 22 | 2 | 39 | 0 |
| Faigel et al[82], 1996 | United States | Cross-sectional | 50 | 42.6 | HE or RUT | 14C-UBT | Positive: > 200 dpm in any sample/borderline: 100-200 dpm (as the peak count)/negative: < 100 dpm (in all samples) | 1 | Multiple times | LSC | 18 | 1 | 26 | 2 |
| Goh et al[83], 1995 | Malaysia | Cross-sectional | 63 | 50.8 | HpC or [HE and (RUT or Gram staining)] | 14C-UBT | 1275 dpm | 5 | 15 | LSC | 32 | 0 | 31 | 0 |
| Kao et al[84], 1993 | China | Cross-sectional | 184 | 53.8 | HpC or RUT | 14C-UBT | 150‰ | 5 | 10 | LSC | 99 | 14 | 71 | 0 |
| Vivas et al[85], 1993 | Venezuela | Cross-sectional | 15 | 53.3 | HE | 14C-UBT | 100 dpm | 1 | 20 | β-SC | 8 | 1 | 6 | 0 |
| Novis et al[28], 1991 | Israel | Cross-sectional | 64 | 80.3 | HE | 14C-UBT | 4,7‰ | 10 | Multiple times | LSC | 59 | 3 | 12 | 2 |
CLO: Campylobacter-like organism; HA: Heliprobe Analyser; HE: histopathological examination; HpC: Helicobacter pylori culture; LSC: Liquid scintillation counting; NR: Not reported; RUT: Rapid urease test; SC: Solid scintillation counting; UBT: Urea breath test; β-SC: Beta-scintillation counting.