Bio-Shield 2019-nCov Total Ig (48-wells)



ITEM # C1348

PRICE: $395.00

QTY *  

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

48 wells

Ready to use (precoated)

-

Dilution Microwells

48 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 (6 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.