Performance of a Point-of-Care Device to Detect Herpes Simplex Virus

Background: A point-of-care (POC) device to diagnose Herpes simplex virus (HSV) is needed to improve care.

Objectives: To evaluate the performance of a prototype POC device to detect HSV compared to polymerase chain reaction (PCR).  

Methods: Men and women with known HSV were recruited with and without lesions. At each visit, 2 clinician-obtained swabs from the lesion (or usual lesion site) were obtained. One was tested with the POC device at the bedside. One was tested with PCR for HSV-1 and HSV-2. The used device was submitted for POC testing in the laboratory.  Bedside and laboratory testers were blinded to PCR results.

Results: The 29 subjects recruited (3 men) contributed 23 swabs without a lesion and 11 swabs with a lesion. Oral lesions were reported by 27 subjects; only one had an acute genital outbreak. PCR was positive for 7/11 swabs from lesions, and negative for 23 without lesions. Three subjects with lesions >7 days old who were using antivirals were PCR and POC negative. Four bedside POC and two laboratory POC tests were invalid. Bedside POC detected 4/6 (67%) PCR-positive lesions, and was false positive for 3/21(14%) of PCR-negative no-lesions. Agreement between bedside POC and PCR was moderate (kappa 0.51). In the laboratory, the POC device detected 5/6 (83%) PCR-positive lesions, and yielded a 2/22 (9%) false positive rate. Agreement between laboratory POC and PCR was good (kappa 0.71).

Conclusions: In this small pilot sample, the POC HSV device shows promise but seemed to perform better in the laboratory than at the bedside.  

Implications for Programs, Policy, and Research: Preclinical studies can inform the design of large clinical trials. It is difficult to recruit individuals with acute HSV outbreaks for whom the device would be most useful. Comparisons of bedside and laboratory performance can lead to device enhancements early in product development.