Product name : CE approved antigen rapid test home kit for professional use
Intend use : The COVID-19 Antigen Rapid Test Device (Colloidal Gold) is a rapid visual immunoassay for the qualitative, presumptive detection of COVID-19 antigens from throat swab, nasopharyngeal swab and nasal swab specimens. The test is intended for use as an aid in the rapid differentia l diagnosis of acute COVID-19 virus infection.
Product images :
Kit component :
| Individually Packed Test Devices | Each test contains colored conjugates and reactive reagents precoated at the corresponding regions |
| Extraction solution | For specimens extraction |
| Extraction tubes | For specimen preparation |
| Nasopharyngeal swabs | For specimen collection |
| Oropharyngeal swabs | For specimen collection |
| Package insert | For operating instructions |
PERFORMANCE CHARACTERISTICS:
| PCR | COVID-19 Ag Rapid Test | ||
| Positive | Negative | TOTAL | |
| Positive | 145 | 5 | 150 |
| Negative | 0 | 487 | 487 |
| TOTAL | 145 | 492 | 637 |
|
Relative Sensitivity: 145/150 96.67% (95%CI:92.39%~98.91%) Relative Specificity: 487/487 100% (95%CI:99.39%~100%) Overall Agreement: 632/637 99.22% (95%CI:98.18%~99.74%) |
|||
Product advantages :
BfArM listed AT060 / 20
PEI evaluated under highly approval
Easy to use ,Multi languages IFU available
Reliable test result in 10-15 minutes
Complete test kit included
Very high sensitivity: 96.5%
Very high specificity: 99.9%
Contents: 25 tests including consumables
Package details :
Standard package 25tests/box ,40boxes(1000tests)/master carton .
G.W.: 13.5kgs/ctn
Carton size :52*38*40CM
Supply ability :800,000tests per week
Departure :SHANGHAI PORT
Lead time :
| Quantity(Pieces) | 10,000-100,000 | >100,000 |
| Est. Time(days) | 2-3days | 4-5days |
FAQ:
Q: Are you trading company or manufacturer ?
A: We are manufacturer. Our factory is located in Hangzhou City ,Zhejiang Province .China .
We are in very good advantages for controlling cost and very strictly quality management system to make sure our products in perfect shape and guanrantee quality before delivery .
Q: How does your factory control product quality?
A: We strictly follow the ISO:13485 QMS.
R&D team devoted to the technology development.
Skillful workers stick to the standard operation procedure.
Quality Control department carefully inspect the production and package process.
Q: What about the warranty?
A: Warranty for meters: 24 Months
Shelf life for meters under electrochemical method is 5 Years; For photochemical meters 4years
Shelf life for electrochemical test strip: 24 Months
Shelf life for dry chemistry test strip: 12 Months
Q: What is your general international express?
A: FedEx, DHL, UPS, EMS … are optionable
