PERFORMANCE SPECIFICATIONS
1. Detection limitation: 200 copies /mL.
2. Precision: using precision reference CV1 and CV2 for within-batch and
between-batch detection, the coefficient of variation (CV) of their Ct values
is â?¤ 5.0%.
3. Conformity rate of Negative Control: 100%
4. Conformity rate of Positive Control: 100%
5. Specificity: This product will not cross react with positive samples of
human coronavirus HKU1 OC43, NL63 and 229E, SARS coronavirus, MERS
corona-virus, H1N1 (new influenza A (H1N1) virus (2009), the seasonal
H1N1) and H3N2, H5N1, H7N9, influenza B Yamagata, Victoria, respiratory
syncytial virus type A, B, parainfluenza type 1, 2, 3, rhinovirus species A, B
and C, adenovirus, 1, 2, 3, 4, 5, 7 and 55, enterovirus species A, B, C,
D,Human pulmonary virus, partial pulmonary virus, EB virus, measles virus,
human cytomegalo virus, rotavirus, norovirus, mumps virus, varicella-zoster
virus and mycoplasma pneumoniae, chlamydia pneumoniae, legionella,
bordetella pertussis, haemophilus influenzae, staphylococcus aureus,
streptococcus pneumoniae, pyogenic streptococcus, klebsiella pneumoniae,
mycobacterium tuberculosis, pyogenic streptococcus, candida albicans,
candida glabrata, newborn Cryptococcus and human genome DNA.