LYHER NOVEL CORONAVIRUS (2019-nCoV)
IgM/IgG Antibody Combo Test Kit (Colloidal Gold)
LYHER One Step Rapid Test Kit
Intended for qualitative detection of IgM/IgG antibodies against novel coronavirus in Human Serum, Plasma or Whole Body for patients with clinical suspicion of Novel Coronavirus (2019-nCoV) infection. For in-vitro diagnostic use.
Advantages of the Product
- Rapid Screening within 10 MINUTES
- High Detection Efficiency - Simultaneous Monitoring of IgM and IgG
- Detection without any Testing Equipment
- Easy to Operate, Compatible with Serum/Whole Blood/Plasma
- Room Temperature Condition – Preserve 2- 30 Degrees Celsius
Frequently Asked Questions
Important information you need to know about our COVID19 Rapid Test Kit
- MDRX Enterprise is an FDA Licensed Medical Distributor in the Philippines.
- Please click here for our LICENSE TO OPERATE document for your reference
- The Rapid Test Kit, LYHER NOVEL CORONAVIRUS (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold), has a SPECIAL CERTIFICATION OF COVID-19 DIAGNOSTIC KITS issued by the Philippine FDA last May 15, 2020.
- LYHER NOVEL CORONAVIRUS (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) also has Therapeutic Good Administration (TGA) letter of Inclusion from Australia.
- Please click this link for the SPECIAL CERTIFICATION OF COVID-19 DIAGNOSTIC KITS and Therapeutic Good Administration (TGA) Letter of Inclusion
- The Rapid Testing should only be conducted by a LICENSED MEDICAL DOCTOR with full Personal Protective Equipment (PPE).
- Accomplish the following documents when doing the testing:
- Case Investigation Form (RITM Document)
- Annex A Document (Send the Department Memorandum No. 2020-0180)
- Read the Department Memorandum No. 2020-0180 for more information on how to handle the result of Rapid Testing.
- MDRX Enterprise will coordinate with its Service Provider for administration of the test. This will incur additional fee because the only allowed personnel to do the testing is a Medical Doctor.
- Antibody Rapid Testing indirect detects the virus by measuring our body’s immune response through the Immunoglobulins (IgM and IgG) to the virus while RT-PCR directly detects the presence of the virus’ genetic material.
- Antibody Rapid Testing requires blood sample for testing while RT-PCR requires Nasopharyngeal Swab.
- Antibody Rapid Testing takes only about an hour to get the result while RT-PCR requires about 2 days.
Kindly contact us here or through e-mail or Facebook so that we can send you a appropriate quotation based on your volume requirements.
- YES! You can fill up the contact form below and one of our Clinical Instrumentation Specialist will get in touch with you to answer your inquiries.
- The interpretation of the result will come from the Licensed Medical Doctor
- For your reference, you can refer to the Product Brochure for the interpretation of results.
IgM Testing (For Sample Size of 603 people)
- Total Sensitivity: 95.73% (95% Confidence Interval: 92.06% - 98.03%)
- Total Specificity: 99.23% (95% Confidence Interval: 97.78% - 99.84%)
- Total Conformity: 98.01% (95% Confidence Interval: 95.03% - 99.76%)
IgG Testing (For Sample Size of 570 people)
- Total Sensitivity: 98.31% (95% Confidence Interval: 95.15% - 99.65%)
- Total Specificity: 99.23% (95% Confidence Interval: 97.78% - 99.84%)
- Total Conformity: 98.95% (95% Confidence Interval: 96.21% - 99.73%)
Do you need more info? Contact us today to get more details.
Our staff will be in touch with you as soon as soon as possible knowing the urgency of the COVID 19 situation
OFFICIAL DOCUMENTATION
Do you need more info? Contact us today to get more details.
Our staff will be in touch with you as soon as soon as possible knowing the urgency of the COVID 19 situation