GRADE tables: How accurately do the WHO 2010 immunological and clinical criteria predict virological failure in adults on ART?
Authors: George W. Rutherford, Tara Horvath
Immunologic criteria and virological failure
Immunological criteria with definition of virological failure >5000 copies/ml
Bibliography: Labhardt 2012; Moore 2008; Reynolds 2009 Settings: Lesotho, Uganda
Comparison: WHO 2010 immunological criteria and VL >5000 copies/ml Values and uncertainty
around these
Number of participants (studies)
Quality of evidence Importance
Sensitivity
51.7%
38.4–64.8%
2213 (2)
Moderate CRITICAL
Specificity1
93.9%
92.8–94.9%
2213 (2)
Moderate CRITICAL
Positive predictive value1 27.0%
0–97.2%
2288 (3)
Moderate CRITICAL
Negative predictive value1 98.6%
95.3–100%
2213 (2)
Moderate CRITICAL
Immunological criteria with definition of virological failure 50–4,999 copies/ml
Bibliography: Abouyannis 2011; Chaiwarth 2007; Kantor 2009; Labhardt 2012; Mee 2006; Mee 2008; Meya 2009; Moore 2008; Rawizza 2011; Rewari 2010; Reynolds 2009; van Oosterhout 2009 Settings: India, Kenya, Lesotho, Malawi, Nigeria, South Africa, Thailand, Uganda
Comparison: WHO 2010 immunological criteria and VL 50–4999 copies/ml Values and uncertainty
around these
Number of participants (studies)
Quality of evidence Importance
Sensitivity
55.0%
53.0–57.0%
15 388 (9)
Moderate CRITICAL
Specificity1
82.9%
82.2–83.5%
15 388 (9)
Moderate CRITICAL
Positive predictive value1 38.0%
22.6–47.2%
15 581 (12)
Moderate CRITICAL
Negative predictive value1 90.5%
88.3–95.7%
15 388 (9)
Moderate CRITICAL
Immunological criteria with definition of virological failure >10 000 copies/ml
Bibliography: Keiser 2009; Reynolds 2009 Settings: Africa, South America, Uganda
Comparison: WHO 2010 immunological criteria and VL >10 000 copies/ml Values and uncertainty
around these
Number of participants (studies)
Quality of evidence Importance
Sensitivity
16.8%
11.1–23.9%
3142 (2)
Moderate CRITICAL
Specificity1
95.5%
94.7–96.2%
3142 (2))
Moderate CRITICAL
Positive predictive value1 15.0%
1.0–36.3%
3142 (2)
Moderate CRITICAL
Negative predictive value1 96.0%
80.5–100.0%
3142 (2)
Moderate CRITICAL
Clinical criteria and virological failure
Clinical criteria with definition of virological failure >5000 copies/ml
Bibliography: Labhardt 2012 Settings: Lesotho
Comparison: WHO 2010 clinical criteria and VL >5000 copies/ml Values and uncertainty
around these
Number of participants (studies)
Quality of evidence Importance
Sensitivity
NA 0 Non-existent CRITICAL
Specificity1
NA 0 Non-existent CRITICAL
Positive predictive value1 100%
5.5–100%
1 (1)
Very low CRITICAL
Negative predictive value1
Clinical criteria with definition of virological failure 50–4999 copies/ml
Bibliography: Chaiwarth 2007; Hosseinipour 2011; Labhardt 2012; Mee 2006; Mee 2008; Rewari 2010; van Oosterhout 2009 Settings: India, Lesotho, Malawi, South Africa, Thailand
Comparison: WHO 2010 clinical criteria and VL 50–4999 copies/ml Values and uncertainty
around these
Number of participants (studies)
Quality of evidence Importance
Sensitivity
11.0%
5.4–19.3%
919 (3)
Moderate CRITICAL
Specificity1
90.5%
88.3–92.4%
919 (3)
Moderate CRITICAL
Positive predictive value1 45.2%
10.0–75.4%
1047 (6)
Moderate CRITICAL
Negative predictive value1 91.1%
87.2–92.9%
919 (3)
Moderate CRITICAL
Immunological OR clinical criteria with definition of virological failure >5000 copies/ml
Bibliography: Labhardt 2012 Settings: Lesotho
Comparison: WHO 2010 immunological OR clinical criteria and VL >5000 copies/ml Values and uncertainty
around these
Number of participants (studies)
Quality of evidence Importance
Sensitivity
NA 0 Non-existent CRITICAL
Specificity1
NA 0 Non-existent CRITICAL
Positive predictive value1 51.1%
40.5–61.6%
92 (1)
Very low CRITICAL
Negative predictive value1
NA 0 Non-existent CRITICAL
Immunological OR clinical criteria with definition of virological failure 50–4999 copies/ml
Bibliography: Abouyannis 2011; Chaiwarth 2007; Labhardt 2012; Mee 2008; Meya 2009; Rewari 2010; van Oosterhout 2009 Settings: India, Lesotho, Malawi, South Africa, Thailand, Uganda
Comparison: WHO 2010 immunological OR clinical criteria and VL 50-4999 copies/ml Values and uncertainty
around these
Number of participants (studies)
Quality of evidence Importance
Sensitivity
26.6%
19.1–35.3%
896 (3)
Moderate CRITICAL
Specificity1
86.0%
83.8–88.0%
896 (3)
Moderate CRITICAL
Positive predictive value1 49.4%
17.4–63.9%
1583 (6)
Moderate CRITICAL
Negative predictive value1 91.1%
86.4–94.0%
896 (3)
Moderate CRITICAL
GRADE tables: How accurately do the WHO 2010 immunological and clinical criteria predict virological failure in children on ART?
Authors: George W. Rutherford, Tara Horvath
Immunological criteria and virological failure
Immunological criteria with definition of virological failure >5000 copies/ml
Bibliography: Barlow-Mosha 2012; Davies, 2012; Westley 2012 Settings: Cambodia, South Africa, Uganda
Comparison: WHO 2010 immunological criteria and VL >5000 copies/ml Values and uncertainty
around these
Number of participants (studies)
Quality of evidence Importance
Sensitivity
4.5%
3.0–6.5%
4100 (3)
Moderate CRITICAL
Specificity1
99.3%
99.0–99.6%
4100 (3)
Moderate CRITICAL
Positive predictive value1 54.9%
5.0 – 100.0%
4100 (3)
Moderate CRITICAL
Negative predictive value1 85.5%
62.0 – 99.0%
4100 (3)
Moderate CRITICAL
Immunological criteria with definition of virological failure >400 copies/ml
Bibliography: Davies 2011 Settings: South Africa
Comparison: WHO 2010 immunological criteria and VL >400 copies/ml Values and uncertainty
around these
Number of participants (studies)
Quality of evidence Importance
Sensitivity
6.3%
3.4–11.0%
2256 (1)
Moderate CRITICAL
Specificity1
97.7%
96.9–98.3%
2256 (1)
Moderate CRITICAL
Positive predictive value1 20.0%
11.2 – 32.7%
2256 (1)
Moderate CRITICAL
Negative predictive value1 91.8%
90.6 – 92.9%
2256 (1)
Moderate CRITICAL
