Advice

Summary

Summary

AdenoPlus is a point‑of‑care test for diagnosing acute adenoviral conjunctivitis in people of all ages, and can be used in any healthcare setting. Two prospective diagnostic accuracy studies showed the sensitivity of AdenoPlus to be 85% and 39.5%, and its specificity to be 98% and 95.5%, compared with existing laboratory tests. A box of 10 single‑use AdenoPlus tests costs £150, excluding VAT. The test needs no additional equipment or consumables.

Product summary and likely place in therapy

  • AdenoPlus is a point‑of‑care test for diagnosing adenoviral conjunctivitis in people of all ages.

  • It is designed to be used in any setting where people present with eye conditions, such as primary care, urgent care services and ophthalmology services. If adopted, it would be used as an alternative to existing laboratory tests that are currently carried out for managing persistent or high‑risk infectious conjunctivitis.

Effectiveness and safety

  • The published evidence summarised in this briefing comes from 3 studies including a total of 571 people.

  • One US‑based multicentre prospective diagnostic accuracy study compared the AdenoPlus test with both polymerase chain reaction (PCR) and viral cell culture with confirmatory immunofluorescence assay (CC‑IFA) in 128 consecutive patients with suspected acute viral conjunctivitis based on clinical examination. AdenoPlus had a sensitivity of 85% and specificity of 98% compared with PCR, a sensitivity of 90% and specificity of 96% compared with CC‑IFA, and a sensitivity of 93% and specificity of 98% compared with both CC‑IFA and PCR.

  • One UK‑based prospective diagnostic accuracy study compared the AdenoPlus test with PCR in 109 consecutive patients presenting to an emergency eye unit with symptoms of acute adenoviral conjunctivitis. Compared with PCR, the AdenoPlus test had a sensitivity of 39.5% and a specificity of 95.5%. No adverse events were reported.

  • The difference in reported sensitivity between the studies may have been caused by inadequate sampling of tear fluid for the reference standard test in the UK study.

  • One cross‑sectional epidemiological study done in France compared the AdenoPlus test with clinical diagnosis in 334 people with acute signs and symptoms of conjunctivitis for less than 7 days. The investigators believed the conjunctivitis was of viral origin in 89% of the people. This was confirmed by the AdenoPlus test in half of these people. No further information was reported that would allow the assessment of test accuracy.

Technical and patient factors

  • AdenoPlus is a single‑use diagnostic test. Each test kit comprises a sample collector, a test cassette and a buffer vial; the test result is available in around 10 minutes.

  • The AdenoPlus test is intended to be used by healthcare professionals.

  • The test is recommended for use within 7 days of developing a red eye consistent with infectious conjunctivitis.

  • The sampling fleece used with the test is made of Dacron, which may cause allergic reactions in some people.

Cost and resource use

  • A box of 10 single‑use AdenoPlus tests costs £150, excluding VAT.

  • No additional consumables are needed.