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 Test

Patient group

Sensitivity (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 ELISA

All patients

17.4%* (9.1–30.7) 8/46

93.8% (71.7–98.9) 15/16

2.8 (0.1–63.3)

0.9 (0.8–0.9)

88.9% (56.5–98.0)

28.3% (17.9–41.6)

HIV positive

21.6%* (11.4–37.2) 8/37

100% (34.2–100) 2/2

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0.8 (0.7–0.8)

100% (67.6–100)

6.5% (1.8–20.7)

CD4 <100 cells/mm3

50%* (25.4–74.6) 6/12

Undefined 0/0

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100% (61.0–100)

0.0% (0.0–39.0)

CD4 >100 cells/mm3

3.5%* (0.6–17.1) 1/28

100% (56.5–100) 5/5

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1.0 (0.8–1.0)

100% (20.6–100)

15.6% (6.9–31.8)

HIV negative

0.0%* (0.0–29.9) 0/9

90% (59.6–98.2) 9/10

0.0

1.1 (undefined)

0.0% (0.0–79.6)

50% (29.0–71.0)

Urine LAM strip test (grade 1 cut-point)

All patients

26.7%* (15.9–41.0) 12/45

91.7% (64.6–98.5) 11/12

3.2 (0.3–35.6)

0.8 (0.7–0.8)

92.3% (66.7–98.6)

25% (14.6–39.4)

HIV positive

33.3%* (20.2–49.6) 12/36

100% (34.4–100) 2/2

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0.7 (0.6–0.7)

100% (75.6–100)

7.6% (2.1–24.1)

CD4 <100 cells/mm3

50%* (25.4–74.6) 6/12

Undefined 0/0

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100% (61.0–100)

(0.0–39.0)

CD4 >100 cells/mm3

18.5%* (8.1–36.7) 5/27

100% (51.0–100) 4/4

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0.8 (0.7–0.9)

100% (56.6–100)

15.3% (6.2–33.6)

HIV negative

0.0%* (0.0–29.9) 0/9

85.7% (48.7–97.4) 6/7

0.0 (undefined)

1.2 (undefined)

0.0% (0.0–79.4)

40% (19.8–64.3)

Urine LAM strip test (grade 2 cut-point)

All patients

26.7%* (15.9–41.0) 12/45

90.9% (62.2–98.4) 10/11

2.9 (0.3–32.6)

0.8 (0.7–0.9)

92.3% (66.7–98.6)

23.3% (13.2–37.7)

HIV positive

33.3%* (20.2–49.6) 12/36

100% (34.4–100) 2/2

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0.7 (0.6–0.7)

100% (75.6–100)

7.6% (2.1–24.1)

CD4 <100 cells/mm3

50%* (25.4–74.6) 6/12

Undefined 0/0

undefined

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100% (61.0–100)

0.0% (0.0–39.0)

CD4 >100 cells/mm3

18.5%* (8.1–36.7) 5/27

100% (51.0–100) 4/4

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0.8 (0.7–0.9)

100% (56.6–100)

15.3% (6.2–33.6)

HIV negative

0.0%* (0.0–29.9) 0/9

85.7% (48.7–97.4) 6/7

0.0 (undefined)

1.2 (undefined)

0.0% (0.0–79.4)

40% (19.8–64.3)

PF LAM ELISA

All patients

11.6%*¥ (6.0–21.3) 8/69

88% (70.0–95.8) 22/25

0.9 (0.08–12.0)

1.0 (0.9–1.1)

72.7% (43.4–90.1)

26.6% (18.2–36.9)

HIV positive

14.5%*¥ (7.6–26.2) 8/55

100% (51.0–100) 4/4

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0.9 (0.8–0.9)

100% (67.6–100)

7.8% (3.1–18.5)

CD4 <100 cells/mm3

27.3%*¥ (13.2–48.2) 6/22

Undefined (0/0)

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100% (61.0–100)

0.0% (0.0–19.4)

CD4 >100 cells/mm3

5.1%*¥ (1.4–16.9) 2/39

100% (67.6–100) 8/8

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0.9 (0.9–1.0)

100% (34.3–100)

17.8% (9.3–31.3)

HIV negative

0.0%*¥ (0.0–21.5) 0/14

100% (75.8–100) 12/12

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1 (undefined)

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46.2% (28.8–64.6)

PF LAM strip test (grade 1 cut-point)

All patients

54.5%*¥§ (42.6–65.9) 36/66

68% (48.4–82.8) 17/25

1.7 (1.2–2.3)

0.7 (0.6–0.8)

81.8% (68.0–90.5)

36.2% (24.0–50.5)

HIV positive

58.5%*¥§ (45.1–70.7) 31/53

75% (30.1–95.4) 3/4

2.4 (0.3–17.4)

0.6 (0.4–0.8)

96.8% (84.3–99.5)

12% (4.2–30.0)

CD4 <100 cells/mm3

68.2%*¥§ (47.3–83.6) 15/22

Undefined 0/0

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100% (79.6–100)

0.0% (0.0–35.4)

CD4 >100 cells/mm3

50%*¥§ (34.4–65.5) 18/36

75% (40.9–92.9) 6/8

2 (0.7–5.9)

0.7 (0.5–0.8)

90% (69.9–97.2)

25% (12.0–44.9)

HIV negative

38.5%*¥§ (17.7–64.5) 5/13

50% (21.5–78.5) 4/8

0.8 (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 patients

19.7%*§ (11.9–30.8) 13/66

84% (65.4–93.6) 21/25

1.2 (0.4–3.7)

0.9 (0.9–1.0)

76.5% (52.7–90.5)

28.4% (19.4–39.5)

HIV positive

20.8%*§ (12.0–33.5) 11/53

100% (51.0–100) 4/4

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0.8 (0.7–0.8)

100% (74.1–100)

8.7% (3.4–20.3)

CD4 <100 cells/mm3

27.3%*§ (13.1–48.1) 6/22

Undefined 0/0

undefined

undefined

100% (61.0–100)

Undefined

CD4 >100 cells/mm3

19.4%*§ (9.8–35.0) 7/36

87.5% (52.9–97.8) 7/8

1.6 (0.06–35.2)

0.9 (0.8–1.0)

87.5% (52.9–97.8)

19.4% (9.8–35.0)

HIV negative

15.4%* (4.3–42.3) 2/13

83.3% (55.2–95.3) 10/12

0.9 (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 patients

95.7%* (88.1–98.5) 67/70

96.3% (81.7–99.3) 26/27

25.8 (3.6–184)

0.045 (0.023–0.09)

91.7% (88.1–94.3)

98.1% (96.8–98.9)

HIV positive

98.2%* (90.6–99.7) 55/56

80% (37.6–96.4) 4/5

4.9 (0.7–34.9)

0.02 (0.003–0.179)

98.2% (90.5–99.7)

80% (37.6–96.4)

HIV negative

100%* (78.5–100) 14/14

100% (77.2–100) 13/13

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100% (78.5–100)

100% (77.2–100)

ADA (Cut-point in current clinical use: ≥35 IU/ml)

All patients

95.7%* (88.1–98.5) 67/70

84% (65.4–93.6) 21/25

6.0 (3.7–9.8)

0.051 (0.026–0.10)

71.9% (67.3–76.1)

97.9% (96.4–98.7)

HIV positive

96.4%* (87.7–99.0) 53/55

40% (11.8–76.9) 2/5

1.6 (0.8–3.1)

0.09 (0.007–1.05)

94.6% (85.4–98.2)

50% (15.0–85.0)

HIV negative

93.3%* (70.2–98.8) 14/15

100% (75.8–100) 12/12

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0.067 (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).
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