DETECTION KIT
The benefits of using the KimForest SARS-CoV-2 Detection Kit are as follows:
– Multiple sample collection tools
– RNA extraction system and reagent kit
– Real-Time PCR System
– Computed automation medical report
– Medical technician training
– Easy laboratory set up
– High sensitivity & specificity
– Extremely low limit of detection
– <2 hours for the entire process
The KimForest SARS-CoV-2 Detection Kit v1 can use oropharyngeal and nasopharyngeal swab specimens, anterior nasal and mid-turbinate nasal swabs, nasopharyngeal washes/aspirates, nasal aspirates, as well as bronchoalveolar (BALs) specimens.
The KimForest SARS-CoV-2 Detection Kit can test 96 individual samples at once.
The KimForest SARS-CoV-2 Detection Kit can accurately produce up to 2000 reports in one day.
It takes the KimForest SARS-CoV-2 Detection Kit less than 100 minutes to produce an accurate result.
The KimForest SARS-CoV-2 Detection Kit can not only accurately detect the original SARS-CoV-2 virus with high sensitivity, but can also accurately detect the variants, all within 100 minutes. The KimForest SARS-CoV-2 Detection Kit is designed to determine different virus strains across Europe, the Americas, and Asia, which would greatly reduce the possibility of an incorrect result. The KimForest SARS-CoV-2 Detection Kit utilizes the updated sequences listed on the GISAID database, a trusted library of influenza and coronavirus data, to guarantee that it will detect the various virus variants.
The KimForest SARS-CoV-2 Detection Kit has no cross-reactivity with common respiratory flora and pathogens.
Our limit of detection in producing accurate results is 200 copies of viral RNA per milliliter.
The KimForest SARS-CoV-2 Detection Kit completely automates the process of producing a medical report, meaning that the healthcare professionals operating the machine will have to do minimal work to parse through the data.
CERTIFICATION AND SUPPORT
The KimForest SARS-CoV-2 Detection Kit has attained the following certifications and registrations:
-US FDA EUA Manufacturer Certificate
-US FDA EUA Laboratories Notification- PacGenomics
-US FDA EUA Laboratories Notification- Sun Clinical Lab
-Philippines FDA Certificate
-TFDA Production Certificate
-TFDA Export Certificate
-CE EAR Certificate
-CE Notification
KimForest can arrange our affiliated Pathologist or medical technician to assist in the setting up and validation of the tests on site.
The KimForest SARS-CoV-2 Detection Kit v1 is authorized for use in laboratories certified under the Clinical Laboratory Improvement amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
Although the KimForest SARS-CoV-2 Detection Kit is not approved or cleared, the KimForest SARS-CoV-2 Detection Kit was issued an EUA by the United States government. The United States FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA), which is a declaration that justifies the emergency use of unapproved tests for the detection and diagnosis of the virus that causes SARS-CoV-2.
Currently, there are no United States FDA approved alternative tests. Instead, the FDA has issued EUAs to other test kits as well.