Laboratory validation and clinical performance of a saliva-based test for monkeypox virus allanblitz2023laboratory
Study reporting laboratory validation and clinical implementation of a saliva-based real-time PCR assay for mpox (monkeypox virus) in California (Los Angeles, San Francisco, Palm Springs). The paper reports analytic sensitivity (limit of detection 250 copies/mL) and clinical performance, including saliva Ct values for 22 saliva-positive cases timed relative to symptom onset (Table 2) and paired saliva/skin lesion PCR results timed relative to confirmation date (Table 3).
Analytes
saliva_symptom_onset
Saliva-based TaqMan real-time PCR assay targeting the mpox virus J1L region; Ct values reported for clinical cases, with time referenced to symptom onset (days between symptom onset and positive saliva test). Samples run in triplicate; positives with Ct >=34 repeated for confirmation. Internal control RNase P used.
Measurements only — no shedding model is fitted to this analyte, usually because it is sampled once per participant, leaving no trajectory to fit, or because nothing was ever detected. Open triangles are non-detects, drawn at the assay's censoring limit. See the modelling methods for what these estimates do and do not support.
saliva_confirmation_date
Saliva PCR Ct values for mpox reported for patients with paired saliva/lesion testing; time referenced to confirmation date (time=0 at confirmation date, per CSV). Assay described as saliva-based TaqMan real-time PCR targeting mpox J1L with RNase P internal control; triplicate wells per sample; Ct values reported when available.
Measurements only — no shedding model is fitted to this analyte, usually because it is sampled once per participant, leaving no trajectory to fit, or because nothing was ever detected. Open triangles are non-detects, drawn at the assay's censoring limit. See the modelling methods for what these estimates do and do not support.
skin_lesion_confirmation_date
Skin lesion (lesion swab) PCR results for mpox from paired testing; time referenced to confirmation date (days between saliva test and lesion test reported). Lesion testing performed as Monkeypox (Orthopox) DNA PCR test (Labcorp); Ct values available only for Los Angeles patients, while other sites may provide qualitative positive/negative.
Measurements only — no shedding model is fitted to this analyte, usually because it is sampled once per participant, leaving no trajectory to fit, or because nothing was ever detected. Open triangles are non-detects, drawn at the assay's censoring limit. See the modelling methods for what these estimates do and do not support.