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Background <p>In vitro diagnostic (IVD) kits are essential for diagnosing and treating diseases all over the world. The availability and condition of IVDs in Addis Ababa were assessed in this study, which concentrated on producers, hospitals, regulatory bodies, and diagnostic facilities.</p> Methods <p>Using multistage stratified random sampling, a descriptive cross-sectional study was carried out between 1<sup>st</sup> of October to 31<sup>st</sup> of December 2024. Nine hospitals, three diagnostic facilities, two IVD manufacturing facilities, the distributor, and the Regulator were among the sixteen facilities that participated in the study.</p> Results <p>There were notable differences in the availability of diagnostics between different types of facilities. Only 25% (95% CI [1.3–69.9]) of public hospitals had malaria RDTs available, compared to 100% (95% CI [46.3–100]) of private hospitals (<i>p</i> = 0.048). All hospitals had HIV RDTs, but only 33.3% (95% CI [1.8–87.5]) of diagnostic centers had them (<i>p</i> = 0.030). Hepatitis PCR testing was not available in any hospital (<i>p</i> = 0.006), although it was available only in diagnostic centers (66.7%, 95% CI [12.5–98.2]). HIV viral load testing was available in 66.7% (95% CI [12.5–98.2]) of diagnostic centers and 50% (95% CI [9.2–90.8]) of public hospitals, but not in private hospitals (<i>p</i> = 0.043). Hepatitis (<i>p</i> = 0.04) and pregnancy tests (<i>p</i> = 0.03) showed significant differences by diagnostic area, with 100% availability in diagnostic centers as opposed to lesser coverage in hospitals. Less than fifty IVD tests were used per day across all sites. Private hospitals relied on imports, whereas public hospitals relied on EPSS supplies. Regulatory barriers, supply chain issues, stockouts, high costs, and difficulty with quality control were among the main challenges.</p> Conclusions <p>There are notable differences in IVD availability among Addis Ababa healthcare facilities, especially in public hospitals for routine testing and private hospitals for specialty assays. To increase IVD production, quality, and fair access, stakeholder collaboration is desperately needed.</p>

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Assessments of the in vitro diagnostic kits landscape and availability from selected hospitals and health-related facilities in Addis Ababa, Ethiopia

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月20日

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  • Fanos Tadesse Woldemariyam,
  • Shambel Tadesse,
  • Bilise Wakitole,
  • Abera Motuma,
  • Kalkidan Seifu,
  • Chala Cheburte,
  • Zinash Teferi,
  • Mahlet Zerfu,
  • Beza Tarekegn,
  • Anberber Alemu,
  • Desalegn Muleta,
  • Jemal Mohammed,
  • Dejene Getachew,
  • Daniel Workineh,
  • Adugna Nigussie,
  • Henok Ferede,
  • Mebrat Ejo,
  • Abebe Mengesha,
  • Demise Mulugeta,
  • Dereje Nigussie Woldemichael

摘要

Background

In vitro diagnostic (IVD) kits are essential for diagnosing and treating diseases all over the world. The availability and condition of IVDs in Addis Ababa were assessed in this study, which concentrated on producers, hospitals, regulatory bodies, and diagnostic facilities.

Methods

Using multistage stratified random sampling, a descriptive cross-sectional study was carried out between 1st of October to 31st of December 2024. Nine hospitals, three diagnostic facilities, two IVD manufacturing facilities, the distributor, and the Regulator were among the sixteen facilities that participated in the study.

Results

There were notable differences in the availability of diagnostics between different types of facilities. Only 25% (95% CI [1.3–69.9]) of public hospitals had malaria RDTs available, compared to 100% (95% CI [46.3–100]) of private hospitals (p = 0.048). All hospitals had HIV RDTs, but only 33.3% (95% CI [1.8–87.5]) of diagnostic centers had them (p = 0.030). Hepatitis PCR testing was not available in any hospital (p = 0.006), although it was available only in diagnostic centers (66.7%, 95% CI [12.5–98.2]). HIV viral load testing was available in 66.7% (95% CI [12.5–98.2]) of diagnostic centers and 50% (95% CI [9.2–90.8]) of public hospitals, but not in private hospitals (p = 0.043). Hepatitis (p = 0.04) and pregnancy tests (p = 0.03) showed significant differences by diagnostic area, with 100% availability in diagnostic centers as opposed to lesser coverage in hospitals. Less than fifty IVD tests were used per day across all sites. Private hospitals relied on imports, whereas public hospitals relied on EPSS supplies. Regulatory barriers, supply chain issues, stockouts, high costs, and difficulty with quality control were among the main challenges.

Conclusions

There are notable differences in IVD availability among Addis Ababa healthcare facilities, especially in public hospitals for routine testing and private hospitals for specialty assays. To increase IVD production, quality, and fair access, stakeholder collaboration is desperately needed.