Brief

Monkeypox is a disease of global public health importance as it not only affects countries in west and central Africa, but the rest of the world. Human-to-human transmission can result from close contact with respiratory secretions, skin lesions of an infected person or recently contaminated objects. Transmission via droplet respiratory particles usually requires prolonged face-to-face contact, which puts health workers, household members and other close contacts of active cases at greater risk.   WHO recommends polymerase chain reaction (PCR) is the preferred laboratory test given its accuracy and sensitivity.

Performance

• Test time ≤ 30 min
• Sensitivity: 200 copies/mL
• Suitable for PCR and iPonatic

Parameters

Items	Parameters
Specimen Type	Vesicles or pustules, nasopharyngeal swab, oropharyngeal swab, serum, whole blood
Extraction Platform	One-tube fast release technology Advanced magnetic beads technology
Internal Control	Human gene
PCR Instrument	ABI 7500, QuantStudio™ 5, LightCycler 480, MA-6000, SLAN-96P, QuantGene 9600, Portable Molecule Workstation S-Q31A&B, Portable Molecular Workstation S-Q36A
Sensitivity	200 copies/mL
Spec.	48 T, 12-P
Qualification	CE

Brief

Human cytomegalovirus (HCMV), also called cell inclusion body virus, is a double helix DNA virus and belongs to β genus of herpes virus family, which causes infected cells to enlarge and has a huge intranuclear inclusion. The ways of infection of HCMV is mainly through contact, blood transfusion, intrauterine and birth canal, and the infections are commonly found in fetus, newborns, pregnant women, etc. If the pregnant women are infected, it may cause their newborns congenital monstrosity. When the organism immune deficiency or immune system is under inhibitory state, people can be easily infected by HCMV, such as the patients receiving immunosuppressive therapy after transplantation of organ, the patients receiving malignant tumor chemotherapy and AIDS patients, etc. If these patients are infected by HCMV, it usually causes high mortality and serious diseases.   Clinical tests suggest that HCMV infection hasn’t specific manifestations and it causes harm to multiple organs, especially the liver and lung. A statistical analysis of positive and negative rate of HCMV in various kinds of clinical indications shows HCMV infection is probably related with various diseases, such as Cytomegalovirus hepatitis, Infant hepatitis syndrome, liver dysfunction, pneumonia, Bronchitis, Upper respiratory tract infections, enteritis, enterocolitis, diarrhea, hematemesis, heart failure, etc.   The Human Cytomegalovirus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) is an in vitro nucleic acid amplification test for the detection of HCMV DNA in human urine, serum and peripheral blood samples. It is intended for use as an aid in the diagnosis of an HCMV infection and for observing drug efficacy.

Parameters

Product features	Parameter
Specimen Type	urine, serum, and peripheral blood.
Technical Platform	One-tube fast release technology Advanced magnetic beads technology
Target pathogen	HCMV
Internal Control	cloning plasmid
PCR Instrument	ABI7500, Roche LC 480 and Stratagene Mx3000P
Amplification Time	70 min
Sensitivity	400 copies/mL
Spec.	48T
Qualification	CE