Monkeypox virus (MPXV)
Conditions
Interventions
Direct Test Kit
QuantiVirus
Sponsors
Hangzhou Taiyuan Instant Testing Biotechnology Co Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Clinical specimen: • Prior to the collection of any specimens, an informed consent form must be signed and dated (if applicable). • Suspected or confirmed Mpox infection. Contrived specimen: • Contrived specimen should be prepared using a negative natural clinical specimen and spiked with virus at the concentrations indicated below (if applicable). ? MPXV clade Ib study: 15 specimens at the LoD and 15 specimens covering the range of the test up to 5x LoD. ? To complement weak positive specimens: 5 specimens at LoD and 5 specimens at 2-3x LoD. ? The following information is required if contrived specimens are used: a) Titres, lineages and (if available) NCBI GenBank or GISAID accession number of the Monkeypox virus(es) used for the LoD study; a description on how the organism stocks were prepared and how the titres were determined. b) Detailed step-by-step explanation of the entire testing procedure. *Suspected Mpox infection and symptomatic individuals: The common symptoms of monkeypox include high fever, chills, headache, swollen lymph nodes, muscle aches, and a painful cutaneous eruption that usually appears as raised bumps on the skin and tends to distribute on the face, genitals, and extremities. Due to the similarity in clinical presentations, differential diagnosis should be considered for several conditions, including smallpox, chickenpox (varicella), disseminated herpes zoster, herpes simplex, syphilis, chancroid, and measles, among others.
Exclusion criteria
Exclusion criteria: Exclusion criteria Contaminated specimens with visible contaminating material/tissue due to improper collection, transportation, storage and using; Rejection criteria • User error occurred during processing which the specimen is judged as no longer suitable for analysis; • Specimens that are affected by quality problems of the test or reference reagent (e.g., expired, improperly stored, or contaminated reagents, etc.); • Specimens that cannot be assessed by ZYTCA UlfaQ™ Direct test or the comparator test. • Other situations that the principal investigator considers necessary to exclude the specimen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the diagnostic accuracy of the ZYTCA UlfaQ™ Mpox Direct Test Kit, including qualitative detection of Monkeypox virus (MPXV) and differentiation between MPXV Clade I and Clade II, compared against the QuantiVirus™ MPXV Test as the reference method. | — |
Secondary
| Measure | Time frame |
|---|---|
| This trial does not have the secondary outcome measures. Due to the specific nature of the IVD product, the test result is the primary outcome measure. | — |
Countries
Congo
Contacts
Public ContactMr. Song Gao
Deputy General Manager ZYTCA Biotechnology Co Ltd
Outcome results
None listed