Table 2: Diagnostic accuracy measures of urinary and pericardial fluid LAM Clearview® TB ELISA and the Determine® TB lateral flow point-of-care strip test (definite-TB for sensitivity and non-TB for specificity calculations).

From: The diagnostic accuracy of pericardial and urinary lipoarabinomannan (LAM) assays in patients with suspected tuberculous pericarditis

Diagnostic TestPatient groupSensitivity (95% CI) (n/N)Specificity (95% CI) (n/N)Positive Likelihood ratio, LR+ (95% CI)Negative Likelihood ratio, LR− (95% CI)Positive predictive value, PPV (95% CI)Negative predictive value, NPV (95%CI)
Urine LAM ELISAAll patients17.4%* (9.1–30.7) 8/4693.8% (71.7–98.9) 15/162.8 (0.1–63.3)0.9 (0.8–0.9)88.9% (56.5–98.0)28.3% (17.9–41.6)
HIV positive21.6%* (11.4–37.2) 8/37100% (34.2–100) 2/2undefined0.8 (0.7–0.8)100% (67.6–100)6.5% (1.8–20.7)
CD4 <100 cells/mm350%* (25.4–74.6) 6/12Undefined 0/0undefinedundefined100% (61.0–100)0.0% (0.0–39.0)
CD4 >100 cells/mm33.5%* (0.6–17.1) 1/28100% (56.5–100) 5/5undefined1.0 (0.8–1.0)100% (20.6–100)15.6% (6.9–31.8)
HIV negative0.0%* (0.0–29.9) 0/990% (59.6–98.2) 9/100.01.1 (undefined)0.0% (0.0–79.6)50% (29.0–71.0)
Urine LAM strip test (grade 1 cut-point)All patients26.7%* (15.9–41.0) 12/4591.7% (64.6–98.5) 11/123.2 (0.3–35.6)0.8 (0.7–0.8)92.3% (66.7–98.6)25% (14.6–39.4)
HIV positive33.3%* (20.2–49.6) 12/36100% (34.4–100) 2/2undefined0.7 (0.6–0.7)100% (75.6–100)7.6% (2.1–24.1)
CD4 <100 cells/mm350%* (25.4–74.6) 6/12Undefined 0/0undefinedundefined100% (61.0–100)(0.0–39.0)
CD4 >100 cells/mm318.5%* (8.1–36.7) 5/27100% (51.0–100) 4/4undefined0.8 (0.7–0.9)100% (56.6–100)15.3% (6.2–33.6)
HIV negative0.0%* (0.0–29.9) 0/985.7% (48.7–97.4) 6/70.0 (undefined)1.2 (undefined)0.0% (0.0–79.4)40% (19.8–64.3)
Urine LAM strip test (grade 2 cut-point)All patients26.7%* (15.9–41.0) 12/4590.9% (62.2–98.4) 10/112.9 (0.3–32.6)0.8 (0.7–0.9)92.3% (66.7–98.6)23.3% (13.2–37.7)
HIV positive33.3%* (20.2–49.6) 12/36100% (34.4–100) 2/2undefined0.7 (0.6–0.7)100% (75.6–100)7.6% (2.1–24.1)
CD4 <100 cells/mm350%* (25.4–74.6) 6/12Undefined 0/0undefinedundefined100% (61.0–100)0.0% (0.0–39.0)
CD4 >100 cells/mm318.5%* (8.1–36.7) 5/27100% (51.0–100) 4/4undefined0.8 (0.7–0.9)100% (56.6–100)15.3% (6.2–33.6)
HIV negative0.0%* (0.0–29.9) 0/985.7% (48.7–97.4) 6/70.0 (undefined)1.2 (undefined)0.0% (0.0–79.4)40% (19.8–64.3)
PF LAM ELISAAll patients11.6%*¥ (6.0–21.3) 8/6988% (70.0–95.8) 22/250.9 (0.08–12.0)1.0 (0.9–1.1)72.7% (43.4–90.1)26.6% (18.2–36.9)
HIV positive14.5%*¥ (7.6–26.2) 8/55100% (51.0–100) 4/4undefined0.9 (0.8–0.9)100% (67.6–100)7.8% (3.1–18.5)
CD4 <100 cells/mm327.3%*¥ (13.2–48.2) 6/22Undefined (0/0)undefinedundefined100% (61.0–100)0.0% (0.0–19.4)
CD4 >100 cells/mm35.1%*¥ (1.4–16.9) 2/39100% (67.6–100) 8/8undefined0.9 (0.9–1.0)100% (34.3–100)17.8% (9.3–31.3)
HIV negative0.0%*¥ (0.0–21.5) 0/14100% (75.8–100) 12/12undefined1 (undefined)undefined46.2% (28.8–64.6)
PF LAM strip test (grade 1 cut-point)All patients54.5%*¥§ (42.6–65.9) 36/6668% (48.4–82.8) 17/251.7 (1.2–2.3)0.7 (0.6–0.8)81.8% (68.0–90.5)36.2% (24.0–50.5)
HIV positive58.5%*¥§ (45.1–70.7) 31/5375% (30.1–95.4) 3/42.4 (0.3–17.4)0.6 (0.4–0.8)96.8% (84.3–99.5)12% (4.2–30.0)
CD4 <100 cells/mm368.2%*¥§ (47.3–83.6) 15/22Undefined 0/0undefinedundefined100% (79.6–100)0.0% (0.0–35.4)
CD4 >100 cells/mm350%*¥§ (34.4–65.5) 18/3675% (40.9–92.9) 6/82 (0.7–5.9)0.7 (0.5–0.8)90% (69.9–97.2)25% (12.0–44.9)
HIV negative38.5%*¥§ (17.7–64.5) 5/1350% (21.5–78.5) 4/80.8 (0.3–2.4)1.2 (0.6–2.6)55.5% (26.7–81.1)33.3% (13.8–61.0)
PF LAM strip test (grade 2 cut-point)All patients19.7%*§ (11.9–30.8) 13/6684% (65.4–93.6) 21/251.2 (0.4–3.7)0.9 (0.9–1.0)76.5% (52.7–90.5)28.4% (19.4–39.5)
HIV positive20.8%*§ (12.0–33.5) 11/53100% (51.0–100) 4/4undefined0.8 (0.7–0.8)100% (74.1–100)8.7% (3.4–20.3)
CD4 <100 cells/mm327.3%*§ (13.1–48.1) 6/22Undefined 0/0undefinedundefined100% (61.0–100)Undefined
CD4 >100 cells/mm319.4%*§ (9.8–35.0) 7/3687.5% (52.9–97.8) 7/81.6 (0.06–35.2)0.9 (0.8–1.0)87.5% (52.9–97.8)19.4% (9.8–35.0)
HIV negative15.4%* (4.3–42.3) 2/1383.3% (55.2–95.3) 10/120.9 (0.0–539.1)1.0 (0.8–1.2)50% (15.0–85.0)47.6% (28.3–67.6)
uIFNγ (Intergam) (Youden’s, rule-in and rule-out cut-points: ≥44 pg/ml)All patients95.7%* (88.1–98.5) 67/7096.3% (81.7–99.3) 26/2725.8 (3.6–184)0.045 (0.023–0.09)91.7% (88.1–94.3)98.1% (96.8–98.9)
HIV positive98.2%* (90.6–99.7) 55/5680% (37.6–96.4) 4/54.9 (0.7–34.9)0.02 (0.003–0.179)98.2% (90.5–99.7)80% (37.6–96.4)
HIV negative100%* (78.5–100) 14/14100% (77.2–100) 13/13undefinedundefined100% (78.5–100)100% (77.2–100)
ADA (Cut-point in current clinical use: ≥35 IU/ml)All patients95.7%* (88.1–98.5) 67/7084% (65.4–93.6) 21/256.0 (3.7–9.8)0.051 (0.026–0.10)71.9% (67.3–76.1)97.9% (96.4–98.7)
HIV positive96.4%* (87.7–99.0) 53/5540% (11.8–76.9) 2/51.6 (0.8–3.1)0.09 (0.007–1.05)94.6% (85.4–98.2)50% (15.0–85.0)
HIV negative93.3%* (70.2–98.8) 14/15100% (75.8–100) 12/12undefined0.067 (0.009–0.473)100% (78.5–100)92.3% (66.7–98.6)
  1. *uIFNγ and ADA sensitivity was significantly better than urinary and PF LAM ELISA and strip tests, for all patient categories (p < 0.001).
  2. ADA specificity was significantly higher in HIV negative patients (p = 0.003).
  3. ¥PF LAM strip test grade 1 sensitivity was significantly higher than PF LAM ELISA (All patients p < 0.001; HIV positive patients p < 0.001; CD4 <100 cells/mm3 p = 0.006; CD4 >100 cells/mm3 p < 0.001; HIV negative patients p = 0.01).
  4. §PF LAM strip test grade 1 sensitivity was significantly better than PF LAM strip test grade 2 (All patients p < 0.001; HIV positive patients p < 0.001; CD4 <100 cells/mm3 p = 0.006; CD4 >100 cells/mm3 p = 0.006).