Table 3.
List of studies reporting urine sampling, serum/plasma-urine comparative methods, and risk of bias
| Drug | Study | Population type | Sample size | Sampling | Urine sampling times | Analytical method | Urine-serum/plasma ratio | Urine-serum/plasma comparison methods | Risk of bias (overall) |
|---|---|---|---|---|---|---|---|---|---|
| Rifampin | Burkhardt et al. [37] | TB | 319 | ND | 2, 4, 6, 8, and 24 h post-dose | Chemical reaction and visual detection | N/A | N/A | Moderate |
| Chatterjee et al. [40] | HV | 1 | N/A | N/A | Fluorescence quenching | N/A | N/A | Low | |
| Eidus et al. [41] | Volunteers | 9 | Day of dose administration | 0, 1, 2, 4, 6, 8, 12, and 24 h post-dose | Chemical reaction and visual detection | N/A | N/A | Low | |
| Espinosa-Mansilla et al. [42] | TB | 1 | ND | ND | Chromatography with photometric detection | N/A | N/A | Low | |
| Meissner et al. [43] | TB | 174 | ND | ND | Visual detection with color reference | N/A | N/A | Low | |
| Mitchison et al. [44] | TB | 19 | ND | 0, 2, 4, 8, 12, 24, 28, 32, 36, and 48 h post-dose | Plate diffusion assay | N/A | N/A | Low | |
| Mqoqi et al. [45] | TB | 270 | ND | ND | Chemical reaction and visual detection | N/A | N/A | Low | |
| Palanduz et al. [46] | TB (pediatric) | 45 | 0.5, 1, 2, 3, 4, 5, and 6 months after treatment initiation | Second urine after medication ingestion | Chemical reaction and visual detection | N/A | N/A | Low | |
| Sirgel et al. [47] | TB | Study 1: 57; Study 2: 46 | Study 1: 2 days before to 5 days after; Study 2: day of visit | Study 1: baseline, 24, 48, 72, 96, and 120 h post-dose; Study 2: 2-h intervals for 8 h post-dose | Study 1: microbiologic assay, visual detection after addition of chemicals; Study 2: HPLC | N/A | N/A | Low | |
| Szipsky et al. [15] | TB (pediatric) | 12 | Two weeks after treatment initiation | 2 h post-dose | Colorimetry, mobile phone/light box | ND | Correlations, receiver operating characteristic curve for target Cmax , and AUC0–24 | Moderate | |
| Wardman et al. [48] | TB | 113 | ND | ND | Visual detection, chemical reaction, chromatographic methods (unspecified) | N/A | N/A | Low | |
| Zentner et al. [11] | TB + HV | 45 | HV: On dose administration day. TB: ND | HV: 4 h, 8 h post-dose. TB: 8 h post-dose | Colorimetry | ND | Correlation, receiver operator characteristic curve | Moderate | |
| Rifapentine | Sirgel et al. [47] | TB | Study 1: 57; Study 2: 46 | Study 1: 2 days before to 5 days after; study 2: day of visit | Study 1: baseline, 24, 48, 72, 96, and 120 h post-dose; study 2: 2-h intervals for 8 h post-dose | Study 1: microbiologic assay, visual detection after addition of chemicals; Study 2: HPLC | N/A | N/A | Low |
| Isoniazid | Amlabu et al. [49] | IPT (pediatric) | 41 | Visit day | 4 and 24 h after dose in daily therapy. 4, 48, and 72 h after dose in intermittent therapy. | Arkansas method + HPLC-MS/MS | N/A | N/A | Low |
| Anusiem et al. [50] | HV | 5 | After first-dose administration | 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, and 48 h post-dose | Spectrophotometry | ND | ND | Low | |
| Burkhardt et al. [37] | TB | 319 | ND | 2, 4, 6, 8, and 24 h post-dose | Chemical reaction (visual detection) | N/A | N/A | Moderate | |
| Eidlitz-Markus et al. [51] | LTBI (adults, pediatric, adolescents) | 105 | During routine follow-up | Once | Arkansas method | N/A | N/A | Low | |
| Elizaga et al. [52] | TB + HV | 51 | ND | ND | Arkansas method | N/A | N/A | Low | |
| Ellard et al. [39] | HV | 39 | On the day of study | Sub-study 1: 0, 0–1, 1–2, 2–3, 3–4, 4–6, 6–8, 8–10, 10–12, 12–21, 21–23, 23–25, 25–27 or, 0, 0–10, 10–12, 12–14, 14–16, 16–18, 18–21, 21–23, 23–25 h post-dose | Fluorimetry and visual detection | N/A | N/A | Moderate | |
| Sub-studies 2 and 3: 0, 0–1, 1–2, 2–3, 23.5, 23.5–24.5. 0, 0–1, 17.5, 17.5–18.5 | |||||||||
| Sub-study 4: 0, 0–2, 2–4, 4–6, 23.5–24.5, 47.5–48.5 | |||||||||
| Sub-study 5: 0, 0–1, 1–2, 2–3, 3–4, 4–6, 6–8, 8–10, 10–12, 12–24 | |||||||||
| Guerra et al. [53] | TB + IPT | 94 | ND | 24 h after observed ingestion | Arkansas method | N/A | N/A | Low | |
| Hamilton et al. [54] | TB + HV | 1673 samples (unknown participant number) | ND | ND | Chemical reaction (visual detection) | N/A | N/A | Low | |
| Hanifa et al. [55] | TB + HV | 213 | At least 3 days after therapy initiation | 6, 12, and 24 h post-dose | Arkansas method | N/A | N/A | Low | |
| Hashiguchi et al. [38] | HV | 4 | On the day of study | 0–4 h, 4–8 h, 8–12 h, and 12–24 h post-dose | Thin-layer chromatography and HPLC validation | N/A | N/A | Moderate | |
| Kendall et al. [56] | IPT | 296 | On enrollment day | One sample on enrollment day | Arkansas method | N/A | N/A | Low | |
| LaCourse et al. [57] | IPT (pediatric) | 150 | ND | ND | Visual detection using dipstick (Arkansas method) | N/A | N/A | Low | |
| Macfadyen et al. [58] | TB | 440 | ND in parent study. Day of first isoniazid ingestion in validation study | Once during random home visit or follow-up (0, 2, 4, 6, 9, and 24 h post-dose in validation study) | Paper test: visual detection | N/A | N/A | Low | |
| Macintyre et al. [36] | TB | 173 | ND | ND | HPLC | N/A | N/A | Low | |
| Meissner et al. [43] | TB | 234 | ND | ND | Dipstick (in-house Arkansas method compared to Taxo INH strips) | N/A | N/A | Low | |
| Mishra et al. [59] | TB + HV | 15 | ND | ND | Micellar liquid chromatography | N/A | N/A | Low | |
| Mqoqi et al. [45] | TB | 270 | ND | ND | Chemical reaction (visual detection) | N/A | N/A | Low | |
| Narain et al. [60] | ND | 4044 samples (unknown participant number) | During study visits | 24, 48, and 72 h post-dose | Visual detection (Belles-Littleman filter paper spot test) | N/A | N/A | Low | |
| Nicolau et al. [14] | TB , LTBI, non-TB | 195 | ND | ND | IsoScreen method (visual detection) | N/A | N/A | Low | |
| Palanduz et al. [46] | TB (pediatric) | 45 | 0.5, 1, 2, 3, 4, 5, and 6 months after treatment initiation | Second urine after medication ingestion | Chemical reaction (visual detection) | N/A | N/A | Low | |
| Perry et al. [61] | LTBI (adolescents) | 194 | Once a month for 9 months | Once per visit | Arkansas method | N/A | N/A | Low | |
| Schmitz et al. [62] | LTBI (adults and adolescents) | 26 | Day of visit | ND | Arkansas method | N/A | N/A | Low | |
| Schraufnagel et al. [63] | TB | 94 | ND | ND | Arkansas method | N/A | N/A | Low | |
| Sirgel et al. [47] | TB | Study 1: 52; Study 2: 46 | Study 1: ND; Study 2: between 4 and 6 weeks after therapy initiation | Study 1: ND; Study 2: 2-h intervals for 8 h | Mycodyn Uritec test strips, chemical reaction (visual detection), HPLC | N/A | N/A | Low | |
| Soobratty et al. [64] | TB , LTBI | 105 | Day of visit | 12, 24, 48, and 72 h post-dose | IsoScreen method (visual detection) | N/A | N/A | Low | |
| Subbaraman et al. [65] | TB | 650 | Random | Once during random home visit | Arkansas method | N/A | N/A | Low | |
| Szakacs et al. [66] | IPT + HV | 306 | Day of visit | 0, 24, 36, and 72 h post-dose in healthy volunteers | Visual detection, chromatography | N/A | N/A | Low | |
| Venho et al. [67] | TB | 26 | ND | 24 h post-dose | Spectrophotometry | ND | N/A | Low | |
| Whitfield et al. [68] | TB , LTBI | 191 | ND | ND | Arkansas method | N/A | N/A | Low | |
| Zhao et al. [69] | ND | 6 | ND | ND | Fluorimetry with silver nanocluster sheets | ND | ND | Low | |
| Pyrazinamide | Burkhardt et al. [37] | TB | 319 | ND | 2, 4, 6, 8, and 24 h post-dose | Chemical reaction (visual detection) | N/A | N/A | Moderate |
| Palanduz et al. [46] | TB (pediatric) | 45 | 0.5, 1, 2, 3, 4, 5, and 6 months after treatment initiation | Second urine after medication ingestion | Chemical reaction (visual detection) | N/A | N/A | Low | |
| Pines et al. [70] | TB | ND | ND | ND | Visual detection | N/A | N/A | Low | |
| Zentner et al. [12] | HV, TB | 45 | HV: Day of drug intake; TB: within 2 months of therapy initiation | HV: 4 h, 8 h post-dose; TB: 4 h post-dose | Colorimetry | ND | Receiver operating characteristic curve | Moderate | |
| Levofloxacin | Rao et al. [13] | TB + HV | 16 | HV: day of dose administration; TB: > 2 weeks after therapy initiation | 0–4, 4–8, and 8–24 h intervals post-dose | Colorimetry | ND | Correlation, receiver operating characteristic curve | Moderate |
| Cycloserine | Mattila et al. [71] | TB + HV | 11 | ND | 8 h after last dose | Chemical assay, bioassay | ND | ND | Low |
| Ethionamide | Eidus et al. [72] | HV | 8 | After first-dose administration | 2–8 h post-dose | Chemical reaction (visual detection) | N/A | N/A | Low |
| Eidus et al. [73] | HV | 14 | After first-dose administration | 1, 2, 3, 6, 7, 8, 10, 12, 14, 18, 24, 26, 28, 30, and 32 h post-dose | Chemical reaction (visual detection) | N/A | N/A | Low |
h hours, HPLC high performance liquid chromatography, HPLC-MS/MS high performance liquid chromatography mass spectrometry/mass spectrometry, HV healthy volunteers, IPT isoniazid preventative therapy, LTBI latent TB infection, N/A not applicable, ND not described, TB tuberculosis