An optimized 13C-urea breath test for the diagnosis of H pylori infection

Table 3 ¹³C-UBT protocol with best diagnostic performance from each study with samples obtained within 30 min of ¹³C-urea administration: Review of literature

First author(reference)	Year	Measuring equipment	Gold standard	n	Pre-analytical	13C-urea dose(mg)	13C-urea formulation and via of administration	Test meal	Additional information related to 13C-urea administration	t	Cut-off point(DOB)	Sens.(%)	Spec.(%)	PPV(%)	NPV(%)	Acc.(%)
Braden[32]	1994	IRMS	13C-UBT	217	Overnight fasting	75	NA	None		20	5	99	100
Koletzko[33]	1995	IRMS,NDIRS	13C-UBT	51	Overnight fasting	75	Powder in 150 mL 0.033 mol/L citric acid solution	Taken with 13C-urea		15	5	100	100
Klein[34]	1996	IRMS	H	465	NA	125	Powder in 90 mL sterile water (Meretek kit)	Ensure		30	2.4	95.4	87.9			94.8
Malaty[35]	1996	IRMS	H, RUT, C	66	Overnight fasting	125	Powder in 100 mL water	None		20	2.4	96	100
Taniguchi[36]	1996	NDIRS	H	153	Overnight fasting	100	Powder in 30 mL water	None		15	1	97.8	74
Domínguez-Muños[37]	1997	IRMS	H, RUT, C	80	Overnight fasting	80	Powder in 50 mL water	200 mL 0.1 mol/L citric acid solution		30	4	100	100
Epple[38]	1997	IRMS	H	77	Overnight fasting	75	NA	Citric acid		30	1.3	96	100
Kato[39]	1998	IRMS	H, C, RUT	133	Overnight fasting	100	Powder in 100 mL of water	None	Mouth rinsing after 13C-urea	10	3.5	99	100
Miwa[40]	1998	IRMS	H	409	8 h fasting	100	Powder	None	Mouth rinsing before and after 13C-urea	20	5	97	97
Ohara[41]	1998	IRMS	H, RUT, C	248	Overnight fasting	100	Powder in 100 mL tap water	None	Mouth rinsing after 13C-urea	20	2.5	98	98			98
Hamlet[42]	1999	IRMS	13C-UBT, H, RUT, C	134	Overnight fasting	100	Two tablets (Diabact UBT) with 50 mg of 13C-urea + 456 mg of anhydrous citric acid swallowed with 200 mL of water	Taken with 13C-urea		10	1.8	95	100
Leodolter[43]	1999	IRMS	H, RUT, C	50	NA	75	Powder in 200 mL 0.1 mol/L citric acid solution	Taken with 13C-urea		30	4	100	100
Leodolter[44]	1999	IRMS	H, RUT, C	233	NA	75	Powder in 200 mL citric acid solution	Taken with 13C-urea		30	4	95	98			97
Savarino[45]	1999	IRMS	H, RUT	134	Overnight fasting	75	Powder in 150 mL 0.033 mol/L citric acid solution	Taken with 13C-urea		30	5	100	100
Van der Hulst[46]	1999	LARA	H, C	544	NA	100	Powder in 50 mL sterile water	Ensure		30	6.3-7.5	93-95	94-96	95-98	86-94
Gisbert[47]	2000	IRMS	13C-UBT,H	53	Overnight fasting	100	Powder in 50 mL water (TAU-KIT)	None		30	3.3-3.9	100	100
Peng[48]	2000	IRMS	H, RUT, C	136	6 h fasting	100	Powder in 50 mL sterile water	100 mL milk	Mouth rinsing after 13C-urea and laid on their sides, changing sides every 5 min	15	4.8	94	89
Riepl[49]	2000	NDIRS	H, C	100	Overnight fasting	75	Powder in 200 mL orange juice	Taken with 13C-urea		15	6.5	92	94	89	94
Savarino[50]	2000	IRMS	H, RUT	117	Overnight fasting	75	Powder in 150 mL 0.033 mol/L citric acid solution	Taken with 13C-urea		30	5	98	97	98	97	98
Sheu[51]	2000	IRMS	H, C	441	Overnight fasting	100	NA	100 mL of fatty test meal	Mouth rinsing before and after 13C-urea	15	4	98	97
Sheu[52]	2000	IRMS,NDIRS	H, C	177	Overnight fasting	50	NA	100 mL citric acid solution	Mouth rinsing after 13C-urea	15	3.5	96	99	99	97
Wong[53]	2000	IRMS	H, RUT	202	Overnight fasting	75	Powder in 50 mL distilled water	2.4 g of citric acid		30	5	96	98	98	96	97
Yoshida[54]	2000	LARA	H, C, PCR	104	Overnight fasting	100	Powder in 50 mL distilled water	None	Mouth rinsing after 13C-urea	20	2.7	98	100			99
Mana[55]	2001	NDIRS	H	223	Overnight fasting	75	Powder	20 mL 0.1 mol/L citric acid solution		10		100	95	94	100
Wong[56]	2001	IRMS	H, RUT	101	Overnight fasting	75	Powder in 50 mL water	None		30	3.5-4.5	100	100			100
Chua[57]	2002	IRMS	H, RUT, S	100	NA	100	Powder in solution Containing citric acid and 13C-urea		Pacients laid on their left side for 30 min	30	3.5	94	100	100	89
Liao[58]	2002	IRMS	H, RUT	152	Overnight fasting	50	Powder in 50 mL sterile water	200 mL full-cream cow's milk	Patients gargled with water 3 times after 13C-urea and laid on their sides, changing sides every 3 min	15	2.5-3.0	99	97	99	97	99
Ng[59]	2002	IRMS	H, RUT	123	Regular meal within 2 h of the 13C-urea	75	Powder in 50 mL water	2.4 g citric acid in 200 mL solution		30	5.5	93	97	100	97
Chen[60]	2003	NDIRS	H, RUT, C, SAT	586	Overnight fasting	100	Powder in 100 mL of water	None	Patients gargled with water 3 times after 13C-urea and laid down on the left side for 5 min	20	3.5	98	97			98
Gatta[61]	2003	IRMS	H, RUT, C	200	Overnight fasting	50	Tablet (Diabact UBT) with 50 mg of 13C-urea and 456 mg of anhydrous citric acid swallowed with 200 mL of water	Citric acid		10	1.65-3.15	100	100
Gisbert[62]	2003	IRMS	H, RUT	36	Overnight fasting	100	Powder in 50 mL water(TAU-KIT)	200 mL solution with 4.2 g citric acid		30	5	96	100	100	91
Wong[63]	2003	IRMS	H, RUT	150	Overnight fasting	50	Tablet (Diabact UBT) with 50mg of 13C-urea and 456 mg of anhydrous citric acid swallowed with 200 mL of water	Citric acid		20	2.1	100	100
Ohara[64]	2004	IRMS	13C-UBT, H, C, RUT	254	Overnight fasting	100	Film-coated tablet swallowed with 100 mL of water	None		20	2.5	98	98			98
Urita[65]	2004	IRMS	H, S	129	Overnight fasting	100	Powder in 100 mL tap water	None	Sample taken through nostril	20	2.5	100	100			100
Beiki[66]	2005	NDIRS	14C-UBT, H, RUT	76	Overnight fasting	75	Powder in 200 mL orange juice			30	3.5	100	97	98	100	99
Kopacova[67]	2005	IRMS	13C-UBT	27	Overnight fasting	100	Powder in 50 mL distilled water with 1 g citric acid	150 mL Distilled water with 3 g citric acid, orange juice or distilled water		10	3.5	100	100			100
Peng[68]	2005	IRMS	H, RUT, C	50	6 h fasting	100	Capsule with water	None	Mouth rinsing before and after 13C-urea and laid on their sides, changing sides every 5 min	15	4-5	100	100			100
Gatta[69]	2006	IRMS	H, RUT	100	Overnight fasting	25	Dissolved in water	Citric acid (1 g)		30	4.4-6.26	100	100
Mauro[70]	2006	IRMS	H, C	176	Overnight fasting	75	Powder in 100 mL citric acid solution	Taken with 13C-urea		30	3	100	99	95-98	100
Mauro[71]	2006	IRMS	H, C	67	Overnight fasting	75	Powder in 100 mL citric acid solution	Taken with 13C-urea		10	3	100	96	95-98	99-100
Present study	2007	IRMS	13C-UBT	70	Overnight fasting	50	Powder in 10 mL sterile water immediately followed by 200 mL sterile water	None	Patients made a circular motion around the waistline for a few times	10	2.0-2.5	100	100	100	100	100

n: Participating individuals; t: Sampling time; PPV: Positive predictive value; NPV: Negative predictive value; Acc: Accuracy; UBT: Urea breath test; H: histology; C: Culture; RUT: Rapid urease test; S: Serology; NA: Not available; IRMS: Isotope ratio mass spectrometry; NDIRS: Non-dispersive infrared spectrometry; LARA: Laser assisted ratio analyser; DOB: Delta-over-baseline.