Bio-Shield 2019-nCov Total Ig (96-wells)
PRICE: $595.00
Description:
Bio-Shield 2019-nCoV Total Immunoglobulins (Ig) is a semi-quantitative ELISA test for the determina-tion of IgA, IgM and IgG against the Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) in human serum or plasma specimens.
Notes:
This ELISA kit is manufactured by ProGnosis Biotech S.A. and complies with the spec-ifications on the Standard EN ISO 13485:2016
This test has not been reviewed by the FDA and is allowed to be marketed under policy D of the FDA Policy for Diagnostic Tests for Coronavirus Disease 2019 during the Public Health Emergency; Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff document issued March 16, 2020.
Intended Use:
The Bio-Shield 2019-nCoV Total Ig is an in vitro immunoassay, assisting in the diagnosis of patients with symptoms suggestive of SARS-CoV-2 infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. In combination with the clinical picture, results of RT-PCR and CT-Scan, Bio-Shield 2019-nCoV Total Ig could be used as an aid in the diagnosis of COVID-19 disease. This immunoassay is a method for the determination of SARS-CoV-2 exposure levels, giving valuable information about the individuals' immune status. Howev-er, the interpretation of the results should not be used as the unique base of the SARS-CoV-2 infection status diagnosis.
All antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, alt-hough the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion.
The sensitivity of Bio-Shield 2019-nCoV Total Ig early after infection is unknown. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
False positive results for Bio-Shield 2019-nCoV Total Ig may occur due to cross-reactivity from pre-existing antibodies or other possible causes.
Reagents Provided:
|
Reagents |
Qty |
State |
Vial cap color |
|
2019-nCoV Total Ig Plate |
96 wells |
Ready to use (precoated) |
- |
|
Dilution Microwells |
96 wells |
Ready to use (red color) |
- |
|
Assay Diluent |
1 plastic vial (50 mL) |
Ready to use |
White |
|
Negative Control |
1 glass vial (0.5 mL) |
Ready to use |
Black |
|
Cut-off Control |
1 glass vial (1 mL) |
Ready to use |
Black |
|
Positive Control |
1 glass vial (0.5 mL) |
Ready to use |
Black |
|
2019-nCoV Total Ig Detection Solution |
1 plastic vial (12 mL) |
Ready to use |
Green |
|
Wash Buffer |
1 plastic vial (50 mL) |
20X Concentrate (dilute in distilled water) |
White |
|
TMB Substrate |
1 plastic vial (6 mL) |
Ready to use |
Brown |
|
Stop Solution |
1 plastic vial (6 mL) |
Ready to use |
White |
Materials required but not provided:
- Clock or timer
- Centrifuge for serum or plasma specimen collection
- Microtiter plate reader fitted with 450 nm filter
- Adjustable single channel micropipettes of 10, 100 and 1000 L with disposable tips (a repetitive pipette of 100-200 L is preferable for the steps of Assay Diluent, Detection Solution, TMB and Stop Solution) and a multi-channel micropipette of 50 - 300 L with disposable tips and reservoir
- Distilled or deionized water, a graduated cylinder of 1000 mL capacity, disposable plastic tubes and absorbent paper
- Protective goggles, gloves and container for biohazardous waste
Warning:
- For in vitro diagnostic use only
- For a medical diagnosis, the serological test result should always be interpreted to-gether with the clinical symptoms of the patient and other result
- Negative results do not rule out SARS-CoV-2 infection
- Test should only be conducted by a medical personnel
- This test has not been reviewed by the FDA
- Results from antibody testing should not be used to diagnose or exclude SARS-CoV-2 infection or to inform infection status
- Positive results may be due to past or present infection with non-SARS-CoV-2 coro-navirus strains, such as coronavirus HKU1, NL63, OC43, or 229E
- Not for the screening of donated blood
General Information/Procedure:
- Test time: 120 min
- Compatible with automated ELISA systems
- Shelf Life: 12 months | Storage 2-8 C
- The test has received the CE-IVD mark and therefore is approved for diagnostic use in the E.U.