Catalogue No. Description IVD or RUO CE Marked Size
30176470 Coronavirus COVID-19 IgM ELISA (12 x 8) IVD Yes 96 tests

This kit is used as an aid for the detection of novel COVID-19. Patients with suspected clustering cases require diagnosis or differential diagnosis of novel coronavirus infection.

For in-vitro diagnostic use only

2019 novel coronavirus (COVID-19) is a single-stranded RNA coronavirus. Comparisons of the genetic sequences of this virus have shown similarities to SARS-CoV and bat coronaviruses. In humans, coronaviruses cause respiratory infections. Coronaviruses are composed of several proteins including the spike (S), envelope (E), membrane (M), and nucleocapsid (N)4. Results suggest that the spike protein retains sufficient affinity to the Angiotensin converting enzyme 2 (ACE2) receptor to use it as a mechanism of cell entry. Human to human transmission of coronaviruses is primarily thought to occur
among close contacts via respiratory droplets generated by sneezing and coughing. IgM is the first immunoglobulin to be produced in response to an antigen and will be primarily detectable during the early onset of the disease.

Instruction for Use

Product information

Product name: Coronavirus COVID-19 IgM ELISA (12 x 8)
Intended use: This kit is intended for the qualitative detection of human anti-COVID-19 IgM antibody in human serum.
Sample type: Human serum
Limit of detection: <5 U/ml Repeatability: The assay control is tested in 10 replicates with a CV of OD values less than 15%.
Reproducibility: Three lots were tested with the same samples 10 times with a CV less than 20%.

For in-vitro diagnostic use Only

Kit Components and Storage

Materials supplied:
1. 96 well microplate coated with COVID-19 IgM
2. COVID-19 IgM Sample Diluent
3. HRP labeled COVID-19 Antigen
4. ELISA Wash Concentrate
5. ELISA HRP Substrate
6. ELISA Stop Solution
7. COVID-19 IgM Negative Control
8. COVID-19 IgM Positive Control

Storage:This test kit must be stored at 2 – 8°C upon receipt. For the expiration date of the kit refer to the label on the kit box. All components are stable until this expiration date.

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