nCOV-19 Real-time PCR (with extraction kits)

The kit should be multiplex assay with capability of detection of at least two target genes and internal extraction control. Negative and positive PCR controls as well as master mix should be included in the kit.The limit of detection with 95% confidence interval (LoD 95) for screening / confirmatory assays should be at least 8 / 10 copies per reaction.The specificity of the kit should be tested to demonstrate the analytical specificity to Coronavirus SARS-CoV-2. It should not show the cross amplification with other human pathogens including human coronaviruses (229 E, HKU1, MERS, SARS, NL63, OC43), Influenza, RSV and other respiratory viruses.The limit of detection with 95% confidence interval (LoD 95) for screening / confirmatory assays should be at least 8 / 10 copies per reaction.The specificity of the kit should be tested to demonstrate the analytical specificity to Coronavirus SARS-CoV-2. It should not show the cross amplification with other human pathogens including human coronaviruses (229 E, HKU1, MERS, SARS, NL63, OC43), Influenza, RSV and other respiratory viruses.

nCov-2019 Rapid  detection kit (IgM/IgG)

Utilizes human whole blood (preferably peripheral), serum, or plasma·  Built-in control (sensitivity) ≥ 90%, specificity ≥ 95%, number of samples used for clinical evaluation ≥ 100; ·  Absence of cross-reactions: human coronavirus panel, HBV, HCV HIV-1 HIV-2 Adenovirus, Parainfluenza virus 1-4, Influenza A, Influenza B, Respiratory syncytial virus, Rhinovirus·  Preferably: Follow up with additional positive and negative control samples, sample collection kit and cross-examination: Human Metapneumovirus (hMPV) Chlamydia pneumoniae Streptococcus pneumoniae Mycobacterium tuberculosis Mycoplasma pneumoniae EB Virus, Enterovirus 71·  Used in rapid, qualitative and differential detection of IgG and IgM antibodies·  Delivers clinical results between 10 and 20 minutes at the point-of-care·  Visual interpretation of results·  No special equipment needed·  CE-Marked, IVD, Safe Packaging, Labeling Method: Immunochromatographic·  STANDARD: to be approved by FDA

nCov-2019 Rapid  detection kit (Antigen)

Tamar Tsenteradze

Procurement Consultant

Europe and Central Asia

T

+995 322 296 272

+995 577 949 424

E

ttsenteradze@worldbank.org

W

www.worldbank.org