# A smartphone-based point-of-care test for detection of Neisseria gonorrhoeae

> **NIH NIH R44** · LUMINOSTICS, INC. · 2020 · $252,131

## Abstract

ABSTRACT
The ultimate goal of this project is CLIP-G, an FDA-cleared and CE-marked smartphone-based test (≤30 min)
for Neisseria gonorrhoeae (NG) detection in women and men for use in over-the-counter (OTC) and point-of-
care (POC) settings. NG causes the 2nd-most common bacterial sexually transmitted infection (STI) with over
550,000 new cases in the US annually. Untreated individuals are at high risk of serious sequelae including pelvic
inflammatory disease, ectopic pregnancy, and infertility. Most NG infections are curable with antibiotics, but the
fact that they cause no symptoms or non-specific symptoms in a majority of those infected necessitates accurate
testing methods. Currently recommended Nucleic Acid Amplification Tests (NAATs) are expensive and have
slow turnaround times; this limits their applicability for expanding testing coverage. Rapid POC tests can curb
disease transmission by enabling a "test and treat" approach and immediate partner notification in a single clinic
visit. An OTC test that can also be used in POC settings will expand testing to the at-risk individuals who do not
currently seek testing due to the stigma around STIs. CLIP-G uses "nanophosphors" – persistent luminescent
inorganic nanoparticles – as lateral flow assay (LFA) reporters in an immunoassay for NG-specific antigens in
combination with a smartphone’s flash and camera and an inexpensive adapter for readout. The CLIP platform
enables orders-of-magnitude better detection limits compared to traditional LFAs. Current antigen-based assays
for NG are highly specific but have poor clinical sensitivity due to their high limit of detection (LOD). The central
hypothesis of this project is that the vastly improved LOD of the CLIP-G immunoassay compared to existing NG
immunoassays will result in clinical sensitivities >90% compared to NAATs without compromising on high
specificity (>98%). In Phase I of this Fast-Track project, we will develop “v1 CLIP-G” benchtop prototypes for
sensitive and specific NG detection and evaluate preliminary analytical inclusivity using sub-cultured clinical NG
isolates; we will also evaluate the clinical feasibility of v1 CLIP-G prototypes in a small-N retrospective clinical
study. Assuming we can obtain preliminary validation of the project’s central hypothesis in Phase I, we will move
on to Phase II, in which we’ll first iteratively design and develop the ancillary hardware and software components
of the fully integrated CLIP-G kit around the Phase I-developed assay. Thus-developed CLIP-G kits will be
evaluated in usability studies, comprehensive analytical performance studies, and a large (n >1,000) clinical
study using prospectively collected specimens. Luminostics has assembled a team of bioengineers, chemists,
software engineers, microbiologists, clinicians, and manufacturing experts to maximize the odds of success. The
expected outcome of this Fast-Track project is the significant de-risking of the final trial targeting FDA 510(k)...

## Key facts

- **NIH application ID:** 10011617
- **Project number:** 1R44AI152854-01
- **Recipient organization:** LUMINOSTICS, INC.
- **Principal Investigator:** Andrew Slator Paterson
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $252,131
- **Award type:** 1
- **Project period:** 2020-05-01 → 2021-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10011617

## Citation

> US National Institutes of Health, RePORTER application 10011617, A smartphone-based point-of-care test for detection of Neisseria gonorrhoeae (1R44AI152854-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10011617. Licensed CC0.

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