2019-nCoV Antibody Test Kit (Colloidal Gold) for COVID-19 Detection

PriceEnquiry to get price & all documents.

Capacity20,000,000 Tests/Year

Certification

Trade Assurance

Instructions for Innovita 2019-nCoV IgM&IgG Combo Test

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PRODUCT OVERVIEW

Kits components	1 test + 1 desiccant/ Foil pouch, 20 foil pouches + 1 buffer+1 insert /box. 1 test + 1 desiccant/ Foil pouch, 40 foil pouches + 2 buffer+1 insert /box.	Technology	Detect 2019-nCoV IgM and IgG antibodies by immuno-capture method.
Major Component	1. Mouse anti human IgM&anti human IgG on M and G Line 2. Goat anti-mouse IgG antibody on C Line 3. nCoV recombinant antigens concentration conjugated to Gold Nanoparticles	Compatible Sample Types	Human serum/plasma/venous whole blood specimen
Sample Pad	Glass fiber	Sensitivity	87.3% (95% CI: 80.40% to 92.0%)
Wicking Pad	Wood pulp paper	Specificity	100% (95% CI: 94.20% to 100%)
Plastic Board (base of the test)	PVC	Storage	Store at 4℃~ 30℃ (39.2℉~ 86℉)
Foil Pouch	PET12/AL7/CPP50	No Cross Reactivity	No Cross-reactivity with Influenza A, B, Adenovirus, and many other diseases
Pack	40 tests/box, 20 boxes (26013065mm)/carton, 12.5 kg (0.06m3)/carton (550385295mm)

PRODUCT CERTIFICATION

CE
FDA
NMPA
Certificate for Exportation of Medical Products
CIBG Farmatec
ISO 13485

PRODUCT FEATURES

Test Kits Proven by Authorities

As the first batch of test boxes approved by NMPA, our test kit is also certified by CE, U.S. FDA, and other credible authorities, which enable you to import and sell under regional market standards.

Many provincial hospitals and China CDC used our test kit and gave highly appreciate. You got our commitment to the performance of our kit.

Auxiliary Diagnosis of COVID-19

Innovita’s test kit is intended for the qualitative detection of IgM and IgG antibodies against COVID-19, compliant with in vitro diagnostic use standards.

The kit is for the auxiliary diagnosis, detecting recent cases and previous cases of COVID-19. The confirmation or exclusion of infection should be combined with the patient’s clinical manifestations and other laboratory tests.

Rapid Results in 15 Minutes

The test kit contains IgM and IgG combined detection. This 15-minute test kit from Innovita returns immediate results, which is ideal for POTC (Point-of-care Testing).

It will help speed up the process of COVID-19 testing, allowing institutions to screen more patients and prevent any further spread of the virus.

Reliable & Accurate Results

We conducted clinical research with 5 institutions, collecting 447 cases. Innovita’s test kit comes with a sensitivity of 87.3% and specificity of 100%.

During the asymptomatic phase, we may get a false negative result. So the test results of our kit are for clinical reference only. Diagnosis and treatment should combine with further tests.

Easy to Use

Our test kit is convenient for professionals to use because the test results can be spotted with the naked eye. For example, one purple band appearing at the control line (C) means a negative sample and two purple bands (T and C) mean a positive case.

Equipment-free design and accurate results are potentially useful for areas with limited

QUALITY TEST

Comprehensive Tests From R&D to Final Kits

We built up full quality control and risk control processes to ensure that you can get stable and reliable test kits. Some of the tests we conducted are as follow:

• Sensitivity Test

• Specificity Test

• Hook Effect Test

• Specimen Stability Test

ABOUT US

Leading Manufacturer in the Biological Technology Industry

Established in 2006 in Beijing, Innovita Biological Technology Co., Ltd. is a Chinese high-tech enterprise specialized in R&D, manufacturing, and marketing Fertility, Infectious Diseases, Sexually Transmitted Diseases, TORCH, Respiratory Diseases, Hepatitis, Drug Abuse, Tumor Marker, Gastrointestinal Diseases and Cardiac marker tests. In 2011 Innovita extended a new plant with 250 acres (160,000 square meters) in Tangshan. We can reach an output of 20 million tests each year.

R&D

We attach great importance to independent research and development and advanced scientific management. Our laboratory is equipped with international advanced instruments and equipment. More than 40% of researchers have a master’s degree in our independent R&D team.

Our Value

Innovita fights for the health of people all over the world. We have offered a wide range of test products and services for our clients at home and abroad. We are always ready to add ammunition to people around the world who fight against COVID-19.

TESTIMOMIALS

China Medical Treatment Team of Central Guidance Group

Recently, the medical treatment team of the Central Guidance Group received a donation of 50,000 pcs of 2019-nCoV Ab Tests from your company and have distributed them to designated hospitals that specially receive patients with COVID-19 for antibody diagnosis (for details, see the attached table). It effectively helped clinical diagnosis and improved the efficiency of medical treatment, and has played an active role in fighting the COVID-19 epidemic.

Contact Supplier Now Innovita (Tangshan) Biological Technology Co., Ltd.

Engaged in in-vitro diagnostic tests in China since 2006.

Business Scope:

INNOVITA is a leading manufacturer of diagnostic solutions for respiratory pathogens diagnosis, specialized in colloidal gold, real-time PCR, chemiluminescence, ELISA and biochips. We strive for a more efficient healthcare system to enhance the health and well-being of people all over the world.

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