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SARS-CoV-2 IgG/IgM Rapid Test Kit (Colloidal Gold)
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This rapid test kit is intended for in vitro qualitative detection and differentiation of antibodies to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in serum/plasma/whole blood samples (including venous blood and finger stick blood) specimens from patients suspected of Coronavirus Disease 2019 (COVID-19) infection. It is used as an aid in diagnosing symptomatic or asymptomatic individuals of acute infection together with molecular tests or clinical information. They also can identify individuals who have previously been infected with the SARS-CoV-2 virus and recovered. The test has been authorized only for the detection of IgM and IgG antibodies specific to SARS-CoV-2, not for any other viruses or pathogens, and results should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
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Product Description
产品详细右侧内容:

This rapid test kit is intended for in vitro qualitative detection and differentiation of antibodies to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in serum/plasma/whole blood samples (including venous blood and finger stick blood) specimens from patients suspected of Coronavirus Disease 2019 (COVID-19) infection. It is used as an aid in diagnosing symptomatic or asymptomatic individuals of acute infection together with molecular tests or clinical information. They also can identify individuals who have previously been infected with the SARS-CoV-2 virus and recovered.

The test has been authorized only for the detection of IgM and IgG antibodies specific to SARS-CoV-2,

not for any other viruses or pathogens, and results should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

 Intended use

This rapid test kit is intended for in vitro qualitative detection and differentiation of antibodies to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in serum/plasma/whole blood samples (including venous blood and finger stick blood) specimens from patients suspected of Coronavirus Disease 2019 (COVID-19) infection. It is used as an aid in diagnosing symptomatic or asymptomatic individuals of acute infection together with molecular tests or clinical information. They also can identify individuals who have previously been infected with the SARS-CoV-2 virus and recovered.

The test has been authorized only for the detection of IgM and IgG antibodies specific to SARS-CoV-2,

not for any other viruses or pathogens, and results should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

Product Information

Production name

Test samples

Specifications

PocRoc®SSARS-CoV-2 IgG/IgM Rapid Test Kit (Colloidal Gold)

serum/plasma/whole blood samples

1T/Kit, 10T/Kit, 20T/Kit

Storage Conditions

All reagents are ready to use as supplied. Unopened reagent kits are stable at 4°C ~30°C for 12 months tentatively. It should be used within 1 hour once the pouch is opened. Do not freeze the kit or expose the kit above 37°C during storage.

Samples collection and test procedure

Treat any materials of human origin as infectious and handle them using standard biosafety procedures.

Whole blood

1. Collect blood specimen into a collection tube (venous blood containing EDTA, citrate or heparin ) by venipuncture.

2. Test specimen as soon as possible after collection within 2 hours. Store specimen at 2°C ~8°C if not tested immediately for no more than 2 days.

Finger stick blood

1. Preparation: Disposable micropipette and Lancet, 75% alcohol wet wipe.

2. Massage: gently massage the ring finger to make the local tissue naturally congested.

3. Disinfection: wipe with 75% alcohol wet wipe and leave it dry.

4. Acupuncture: make the skin tight with left hand, hold the Lancet in the right hand and stab it from the inside of the finger end abdomen, fast in and fast out.

5. Blood collecting: squeeze the handle of micropipette to take samples to fill the part of the front thinner end.

Serum/Plasma

1. Collect blood specimen into a red top collection tube (containing no anticoagulants) by venipuncture.

2. Allow the blood to clot.

3. Separate the serum/plasma by centrifugation.

4. Carefully withdraw the serum/plasma into a new pre-labeled tube.

5. Test specimen as soon as possible after collecting within 2 hours. Specimen can be stored at 2°C ~8°C up to 2 days or  frozen -20 °C up to one month if not tested immediately. Avoid twice freeze-thaw cycles. Prior to testing, bring frozen specimen to room temperature slowly and mix

gently. Specimen containing visible particulate matter should be clarified by centrifugation before testing.

6. The assay is unaffected by icterus (bilirubin≤0.2g/L), hemolysis (hemoglobin≤5g/L), lipemia (triglyceride≤10 g/L) .

Assay Procedure

1、 Please read the instructions for use of this product thoroughly before performing the test. For fresh samples, begin with Step 2. For frozen samples, bring the specimens and test components to room temperature, and mix the specimen well once thawed.

2、When ready to test, open the pouch at the notch and remove the test device. Place the test device on a clean, flat surface. (The kit should be used within 1 hour).

3、Label the device with specimen ID number.

4、Take 10mL whole blood (finger stick blood can be used preferably), or serum/plasma, and dispense it into the center part of sample well of the cassette, then add 80mL sample buffer (2 drops) to the sample well, and timing. For better precision and consistant results, transfer specimen by a pipette. The micropipettes tip must resist against the sample pad and make sure the sample completely enters the sample pad before adding the Sample Buffer.

5、Read the result in 10~20 minutes. Do not read the result after 30 minutes.

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