Basic Info.
Product Specification[Product Name]Nucleic Acid detection kit( Real-Time Fluorescent RT-PCR)
[Intended Use]
Nucleic Acid Test Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the , which was identified at Wuhan City, Hubei Province, China, in upper and lower respiratory tract specimens. (such as oropharyngeal swabs, nasopharyngeal swabs and sputum)
For in vitro diagnostic use only. For professional use only
| Usage/Application | Hospital/Lab |
| Form | Liquid |
| Method | RT PCR |
| Certificated | CE/CFDA/TUV/TGA |
| Result Time | about 5~6 HOURS |
| Type of Detection | PCR |
| Sample Type | 1.oropharyngeal swabs 2.nasopharyngeal swabs 3.sputum |
| Positive coincidence rate | 95.93% |
| Negative coincidence rate | 94.07% |
| Total coincidence rate | 94.80% |
| Transportation & Storage Temperature | -20±5 ºC |
| Shelf Life | 6 Months |
| Result Type | Qualitative |
| Specification | 25 tests/kit, 50 tests/kit, 100 tests/kit |
| Package | 20000 tests/packing(200 kits/packing) |
| Package Size | 641x552x743mm |
| Weight | 70KG/package |
| Minimum Order Quantity | 5000 tests |
Delivery time: The delivery cycle depends on your quantity purchased.
( eg: 100,000 tests will delivery 1~3 days after receving the payment )
[Main Components]&[Specimen type]
| Kit components | Specimen type |
| Reaction fluid | Oropharyngeal swabs |
| RT-PCR enzyme | Nasopharyngeal swabs |
| Positive quality control | Sputum |
| Negative quality control |
[Storage Conditions & Validity]
The kit shall be stored in a dark place at -20±5ºC and is valid for 6 months,and repeated freeze-thaw cycles shall be avoided (frozen-thaw times shallnot exceed 5 times). The period of validity and the expiry date of the product are shown on the label.
[Applicable Instruments]
ABI fluorescent PCR platforms, such as ABI7500, ViiATM7, QuantStudio Dx, QuantStudio6 Flex and QuantStudio7 Flex; Agilent fluorescence PCR platforms, such as MX3000P and MX3005P; Bio-rad fluorescence PCR platforms, such as CFX96 and IQ5.
[Product Performance Indicators]
1. Negative coincidence rate: 100%
2. Positive coincidence rate: 100%
3. Limit of detection: 500copies/mL
4. Precision: Ct variable coefficient (CV, %) ≤5%
5. Clinical evaluation: 750 samples of clinical trials were completed in 3
clinical units. Compared with the same reagents approved for marketing,
the positive coincidence rate was 95.93%, the negative coincidence rate
was 94.07%, and the total coincidence rate was 94.80%.
ATTENTION
(1) The product is not colloidal gold. (Nucleic Acid detection kit( Real-Time Fluorescent RT-PCR))
(2)Medical diagnostic kits is not for home use and requires professional medical personnel to use it in a hospital or laboratory
(3) Need to be used with professional PCR instruments, please refer to the manual
(4) Before using nucleic acid detection, it is necessary to take calibration acid from a sample (such as a throat swab). There are two different methodological extraction reagents to choose from. One is the magnetic bead method for nucleic acid extraction reagents, which is used in conjunction with our extraction equipment (the method is easy to operate).
