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ABSTRACTS OF ORAL PRESENTATIONS
OC 8435 MULTI-BIOMARKER TEST STRIP FOR POINT-OF-CARE SCREENING FOR ACTIVE TUBERCULOSIS: A FIVE-COUNTRY MULTI-CENTRE TEST EVALUATION
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  1. Paul Corstjens1,
  2. Anouk Van Hooij1,
  3. Elisa Tjon Kon Fat1,
  4. Shannon Herdigein1,
  5. Anna Ritah Namuganga5,
  6. Azaria Diergaardt6,
  7. Hygon Mutavhatsindi2,
  8. Awa Gindeh3,
  9. Adane Mihret4,
  10. Gian Van De Spuy2,
  11. Gunar Gunther6,
  12. Rawleigh Howe4,
  13. Harriet Mayanja-Kizza5,
  14. Jayne Sutherland3,
  15. Novel N Chegou2,
  16. Tom Ottenhoff1,
  17. Gerhard Walzl2,
  18. Annemieke Geluk1
  1. 1Leiden University Medical Center, The Netherlands
  2. 2Stellenbosch University, South Africa
  3. 3Medical Research Council, Serrekunda, The Gambia
  4. 4Armauer Hansen Research Institute, Addis Ababa, Ethiopia
  5. 5Makerere University School of Medicine, Kampala, Uganda
  6. 6University of Namibia School of Medicine, Windhoek, Namibia

Abstract

Background Inexpensive rapid screening tests that can be used at the point-of-care (POC) are vital to combat tuberculosis. Particularly, less invasive non-sputum-based biomarker tests for all TB forms can help controlling transmission. Availability of such tests would significantly accelerate and streamline diagnostic approaches, improve cost-efficiency and decrease unnecessary costly GeneXpert referrals.

Methods Multi-biomarker test (MBT) devices measuring levels of selections of up to six serum proteins simultaneously on a single lateral flow (LF) strip were produced. The strip contains individual capture lines for a biomarker selection allowing discrimination of TB-patients from other respiratory diseases (ORD). Only biomarkers successfully evaluated with singleplex strips (single biomarker tests) were applied to the MBT device. Quantitative signals are recorded with a low-cost handheld reader compatible with the applied luminescent up-converting particle (UCP) label. Biomarker selection and algorithms used to distinguish potential-TB and ORD are flexible.

Results Results obtained with MBT strips containing multiple test lines correlate well with singleplex LF strips. Using LF tests for 5 selected biomarkers a sensitivity of 94% and specificity of 96% could be achieved with a confirmed South African selection of 20 TB and 31 non-TB samples. Patients were designated TB positive when scoring a value above the cut-off threshold for at least 3 out of 5 biomarkers. Serum samples of potential TB patients collected at five medical research institutes (Ethiopia, Namibia, South Africa, The Gambia, Uganda) were tested locally with MBT strips comprised of CRP, SAA, IP-10, Ferritin, ApoA-I and IL-6 and results analysed to obtain an overall pan-Africa applicable signature.

Conclusion Evaluated POC applicable UCP-LF devices detecting serum biomarker signatures can help to distinguish active TB from other respiratory diseases and as such can prioritise highest-risk patients for further care. Ongoing prospective studies evaluate the MBT strip with fingerstick blood and do not require a laboratory or trained phlebotomist anymore.

https://doi.org/10.1136/bmjgh-2019-EDC.14

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