Personal Protective Equipment(PPE)

2019-nCOV IgG/IgM Antibody Test Cassette Accurate Whole Blood Covid 19 Test

2019-nCOV IgG/IgM Antibody Test Cassette Accurate Whole Blood Covid 19 Test

Specimen: Serum, Plasama or Whole Blood
Storage temperature: 4-30℃
Reading time: 15 mins
Product description: COVID-19 IgG / IgM Ab test is used for qualitative detection of the lgM and IgG antibodies of COVID-19 in human serum / plasma or whole blood.
INQUIRY

Product Description

Product Name	Coronavirus Pneumonia IgG/IgM Ab Test
Brand Name	GOLDEN TIME , OEM-Buyer's logo , ODM
Form/ Dosage Form	In Vitro Diagnostic Medical Device
Specimen	Serum, Plasama or Whole Blood
Format	Cassette
Specificity	No Cross Reaction: Separated IgM/gG strip
Storage temperature	4-30℃
Reading time	15 mins
Shelf time	24 months

1. Each kit contains 25 test devices, each sealed in a foil pouch with three items inside: One cassette device, One plastic dropper, One desiccant. 2. Sample diluent (1 bottle, 7 mL), 25 blood needles, 25 alcohol swabs

3. One package insert (instruction for use).

Product performance description

COVID-19 IgG / IgM Ab test is used for qualitative detection of the lgM and IgG antibodies of COVID-19 in human serum / plasma or whole blood.

This kit (colloidal gold method) is a rapid in vitro diagnostic reagent developed by many scientific research institutions with colloidal gold as indicator, colloidal gold immunochromatography technology, anti human IgG and anti human IgM as coating materials, artificial expression and purification of 2019-nCoV specific antigen as labeling materials.

PERFORMANCE CHARACTERISTICS

COVID-19 IgM Test	RT-PCR		Total
COVID-19 IgM Test	Positive	Negative	Total
Positive	123	3	126
Negative	4	334	338
Total	127	337	464
A statistical comparison was made between the results yielding a sensitivity of 96.9%, a specificity of 98.89% and an accuracy of 97.8%.

CROSS REACTIVITY AND INTERFERE NCE

1. Other common causative agents of infectious diseases were evaluated for cross reactivity with the test. Some positive specimens ofother common infectious diseases were spiked into the Novel coronavirus Ositive and negative specimens and tested separately. No cross reactivity was observed with specimens from patients infected with HIV.AV. HBsAa, HCV. TP, HTLV. CMV, FLUA FLUB, RSV. MP. CP.

2. Potentially cross-reactive endogenous substances indluding common serum components, such as lipids, hemoglobin, bilirubin, were spiked at high concentrations into the Novel coro navirus positive and negative specimens and tested, separately. No cross reactivity or interference was observed to the device.

Analytes	Conc.	Specimens
Analytes	Conc.	Positive	Negative
Albumin	20mg/ml	+	-
Bilirubin	20μg/ml	+	-
Hemoglobin	15mg/ml	+	-
Glucose	20mg/ml	+	-
Uric Acid	200μg/ml	+	-
Lipids	20mg/ml	+	-

3. Some other common biological analytes were spiked into the Novel coronavirus positive and negative specimens and tested separately. No significant interfe rence was observed at the levels listed in the table below.

Product Usage

- Product usage introduction

1.Remove the test from the sealed pouch.Lay it on a flat,clean and dry surface.

2. Using the provided pipette,add 10μl fresh specimen to the sample well.

3. Hold the buffer bottle vertically and add 2 drops (approximate 80μl-100μl)to sample well.

4. Read results in 15 minutes.Don' t read after 15 minutes.

Interpretation of result

IgG&lgM Positive: Control line and T1 line & T2 line appear in the show window.

IgM Positive: Two colored lines appear,one is in T1 area and the other line is in Control area.

IgG Positive: Two colored lines appear,one is in T2 area and the other line is in Control area.

Negative: Only one line appears in Control Area, No line appears in T1/T2 area.

Invalid: lf no line appears in the control area,the test results are invalid regardless of the presence or absence of line in the test area.

The direction may not been followed correctly or the test may be deteriorat ed.It is recommended that repeat the test using a new device.If the problem persist,please stop to use the product and contact local distributor.v

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