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PCL COVID19 IgG/IgM Rapid Gold

Covid-19 Test Kit

PCL COVID19 IgG/IgM Rapid Gold is an in vitro diagnosis kit for qualitative detection of IgG and IgM antibodies of COVID19 infection in human serum, plasma, venous blood and capillary blood. This is a simple and quick test, as no other test instruments are required, and the test result is available after ten minutes. The kits are packed in boxes of 100 kits.

Kit Components

TEST CARD:

With integrated strips coated with antibodies and antigens (pouch seal) – 100 pcs./box.

SPECIMEN DILUENT:

Liquid reagent for sample dilution and development (2 ml/vial) – 8 vials/box.

DISPOSABLE DROPPER:

For collecting samples and dispensing them on the test card – 100 pcs./box.

USER’S MANUAL:

1 piece/100 box

LANCET:

Used to puncture the skin in order to dispense the blood – 100 pcs./box.

ALCOHOL SWAB:

To cleanse the tip of the finger before injection and blood sampling – 100 pcs./box.

 

 

Features

LIMIT DETECTION:

In order to set the minimum detection limit of this product, IgG and IgM positive samples were diluted by concentration using 3 lots of products and repeated 20 times for each test. As a result, IgG was set to 1: 20,000 and IgM was set to 1: 10,000.

CROSS-REACTIVITY:

Substances listed below were confirmed not to have cross-reactivity with PCL COVID19 IgG/IgM Rapid Gold.
– Influenza A IgM, Influenza B IgM, RSV IgM, Parainfluenza IgM, Mycoplasma pneumonia IgM, Chlamydia pneumoniae IgM

INTERFERENCE RESPONSE:

Substances listed below were confirmed not to have interference response with PCL COVID19 IgG/IgM Rapid Gold.
– Hemoglobin, Bilirubin, Triglycerides, Cholesterol, Rheumatoid Factor, EDTA, Sodium citrate, Heparin sodium.

PRECISION:

In order to assure the reproducibility, then this was evaluated between the lots, the equipment, the operators and the test sites. All of the test delivered the same results for all panels tested, affirming reproducibility of the product.

Technical Specifications

Instruction For Use

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