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. 2021 May 4;72(9):e280-e288.
doi: 10.1093/cid/ciaa1052.

Accuracy of a Novel Urine Test, Fujifilm SILVAMP Tuberculosis Lipoarabinomannan, for the Diagnosis of Pulmonary Tuberculosis in Children

Mark P Nicol  1   2 , Samuel G Schumacher  3 , Lesley Workman  4 , Tobias Broger  3   5 , Cynthia Baard  4 , Margaretha Prins  4 , Lindy Bateman  4 , Elloise du Toit  2 , Judi van Heerden  2 , Rita Szekely  3 , Heather J Zar  4 , Claudia M Denkinger  3   5
Affiliations

Accuracy of a Novel Urine Test, Fujifilm SILVAMP Tuberculosis Lipoarabinomannan, for the Diagnosis of Pulmonary Tuberculosis in Children

Mark P Nicol et al. Clin Infect Dis. .

Abstract

Background: An accurate point-of-care test for tuberculosis (TB) in children remains an elusive goal. Recent evaluation of a novel point-of-care urinary lipoarabinomannan test, Fujifilm SILVAMP Tuberculosis Lipoarabinomannan (FujiLAM), in adults living with human immunodeficiency virus (HIV) showed significantly superior sensitivity than the current Alere Determine Tuberculosis Lipoarabinomannan test (AlereLAM). We therefore compared the accuracy of FujiLAM and AlereLAM in children with suspected TB.

Methods: Children hospitalized with suspected TB in Cape Town, South Africa, were enrolled (consecutive admissions plus enrichment for a group of children living with HIV and with TB), their urine was collected and biobanked, and their sputum was tested with mycobacterial culture and Xpert MTB/RIF or Xpert MTB/RIF Ultra. Biobanked urine was subsequently batch tested with FujiLAM and AlereLAM. Children were categorized as having microbiologically confirmed TB, unconfirmed TB (clinically diagnosed), or unlikely TB.

Results: A total of 204 children were enrolled and had valid results from both index tests, as well as sputum microbiological testing. Compared to a microbiological reference standard, the sensitivity of FujiLAM and AlereLAM was similar (42% and 50%, respectively), but lower than that of Xpert MTB/RIF of sputum (74%). The sensitivity of FujiLAM was higher in children living with HIV (60%) and malnourished children (62%). The specificity of FujiLAM was substantially higher than that of AlereLAM (92% vs 66%, respectively). The specificity of both tests was higher in children 2 years or older (FujiLAM, 96%; AlereLAM, 72%).

Conclusions: The high specificity of FujiLAM suggests utility as a "rule-in" test for children with a high pretest probability of TB, including hospitalized children living with HIV or with malnutrition.

Keywords: LAM; children; diagnosis; lipoarabinomannan; tuberculosis.

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Figures

Figure 1.
Figure 1.
Study flow. Abbreviations: AlereLAM, Alere Determine Tuberculosis Lipoarabinomannan test; FujiLAM, Fujifilm SILVAMP Tuberculosis Lipoarabinomannan; HIV, human immunodeficiency virus; TB, tuberculosis.
Figure 2.
Figure 2.
Accuracy of FujiLAM and AlereLAM using a reference standard of confirmed TB versus unconfirmed or unlikely TB in children. Point estimates of sensitivity and specificity are shown together with 95% confidence intervals. Abbreviations: AlereLAM, Alere Determine Tuberculosis Lipoarabinomannan test; FujiLAM, Fujifilm SILVAMP Tuberculosis Lipoarabinomannan; HIV, human immunodeficiency virus; TB, tuberculosis.
Figure 3.
Figure 3.
Venn diagram showing intersection of positive results for lipoarabinomannan tests, Xpert MTB/RIF, and mycobacterial culture. A) The intersection of positive tests amongst 84 children with confirmed TB. B) The intersection of positive tests amongst all children with positive AlereLAM, FujiLAM, microbiological culture, or Xpert MTB/RIF. Abbreviations: AlereLAM, Alere Determine Tuberculosis Lipoarabinomannan test; FujiLAM, Fujifilm SILVAMP Tuberculosis Lipoarabinomannan; HIV, human immunodeficiency virus; TB, tuberculosis; Xpert, Xpert MTB/RIF or Xpert MTB/RIF Ultra.
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References

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