Instructions - Covid-19 Rapid Antibody IgG IgM Test Kits

"serology test" "serologic testing" or "serological diagnostics"

 

 

 

 

Covid-19 Coronavirus IgG IgM Rapid Antibody Home Test Kit

Self-Testing, Home Use, At Home Antibody Test Kit CE-IVD

"serology test" "serologic testing" or "serological diagnostics"

  GLOBAL CERTIFICATIONS 

  Europe, USA, China. Australia, Italy, Columbia 

For at home testing, self test, home use or professional use 

  GLOBAL CERTIFICATES INCLUDE  

  •   EUROPE CE - EUROPEAN CERTIFICATE 

  •   US FDA - AMERICAN CERTIFICATE 

  •   CHINA FSC - CHINA CERTIFICATE 

  •   AUSTRALIA TGA - AUSTRALIAN CERTIFICATE 

  •   ITALY MoH - ITALIAN CERTIFICATE 

  •   COLUMBIA MoH - COLUMBIAN CERTIFICATE 

Items required

  • Timer

 

Intended use
The 2019-nCoV SARS COV 2, (COVID-19) IgG/IgM Combined Rapid Antibody Test Cassette for COVID-19
 is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies for novel Coronavirus  in human whole blood, serum or plasma specimen. The test is able to detect the different stage of Coronavirus or whether the person has had a past COVID-19 infection. 

The rapid antibody serology test detects both the IgM & IgG antibodies in human finger-prick or venous whole blood, serum, and plasma samples to determine the various stage of the COVID-19 Coronavirus infection.

 

Unlike PCR tests that detect COVID-19 Coronavirus for a brief time window of critical infection, the serology rapid IgG / IgM antibody tests are able to detect COVID-19 antibodies for an extended period of time after the Coronavirus infection and enables the test to detect prior infection.

 

Warning & Precaution

Samples for human serum, plasma or whole blood should be considered as potentially infectious. The operator should wear protective clothing, masks, and gloves and take other appropriate safety precautions to avoid or reduce the risk of infection.

 

Storage Conditions

The test cassette should be stored at 2 - 30 degrees centigrade, and the shelf life is 24 months. The test card which is sealed inside the aluminium foil bag should be used within 1 hour of opening.

Test Procedure

  • Wear protected equipment before beginning test

  • Massage tip of ring finger (next to little finger on left hand) for few seconds

  • Wipe tip of ring finger with an alcohol swab

  • Use a lancet (pin prick) to prick finger and pierce the skin

  • Squeeze finger to draw a little blood sample

  • Wipe the finger again with an alcohol swab

  • Tear open the sealed foil case for the test cassette

  • Place the test cassette on a table or flat surface

  • Squeeze finger for few seconds to draw a little blood sample for a few drops

  • Use a pipette / dropper to draw 20 ul of blood sample (2 full drop of blood) avoiding air bubbles

  • Hold the dropper upright and release the 20 ul blood into cassette cartridge specimen well

  • Then add 80ul (2 drops) of buffer / diluent fluid into the test cassette specimen well

  • Set timer for 10 minutes and wait for the coloured lines on the test cassette to appear

  • Take photo of test results with a smartphone for later verification

  • Read the test results from the test cassette in 10- minutes or later from the smart phone photo

  • Do not interpret the results after 15 minutes

  • For health & safety dispose of the lancet, gloves, foil packaging and test cassette in bin

  • Do not use the buffer after 6 months of opening

How to Interpret Results

 NEGATIVE 

C - Denotes the control line and when this is highlighted on its own in red it indicates a negative result, INDICATES NO COVID-19 & NO CORONAVIRUS

 POSITIVE 

C with IgG & IgM denotes a positive result for IgG & IgM

INDICATES SECONDARY COVID-19 INFECTION

C with IgM denotes positive result for IgM

INDICATES PRIMARY COVID-19 INFECTION

C with IgG denoted positive result for IgG

INDICATES PAST COVID-19 INFECTION

 INVALID 

The absence of C with either of the following IgG, IgM, IgG+IgM, or no IgG & no IgM 

INDICATES INVALID OR INCONCLUSIVE TEST -  EXPERIMENT HAD FAILED

This may be due to a number of factors including not enough blood sample, blood sample includes air bubbles, not correct or correct amount of buffer fluid inside the sample tray, reading the results too early  or after 20 minutes have passed or giving rise to inconclusive results.

Box contents

1   Covid-19, Coronavirus Antibody Tests

1   Dropper / pipette

1   Bottle buffer / diluent fluid

1   English user manual with step by step instructions

1   Lancet (pin prick)

1   Alcohol swab

Also available in multiple packs of 6 and 12 single box self tests

6 HOME SELF TESTS COVID-19 "PLATINUM++" Coronavirus IgG IgM Antibody Tests

SKU: 6 COVID-19 HOME TESTS CE - SINGLE

12 HOME SELF TESTS COVID-19 "PLATINUM++" Coronavirus IgG IgM Antibody Tests

SKU: 12 COVID-19 HOME TESTS CE - SINGLE

What is IgM & IgG ?

IgM is the first antibody to appear in the acute infection stage caused by pathogens such as SARS CoV-2, and can normally be detected 3 days after the onset of symptoms.

 

IgG is produced in the middle or later stage of the infection but provides long term protection.

 

In the latest 7th edition of the Diagnosis and Treatment Guideline on the Novel Coronavirus Disease (COVID-19), the SARS-CoV 2 IgG/IgM test is recommended as an aid in the diagnosis of the COVID-19.


SARS-CoV-2 IgG/IgM Kit is used for rapid and accurate screening of the COVID-19, which helps identify suspected patients and reduce false negative rate.

Important

This test kit is a complement to PCR detection in COVID-19 diagnosis

 

Reagents
The test contains anti-human IgM and anti-human IgG as the capture reagent, 2019-nCoV antigen as the detection reagent. A goat anti-mouse IgG is employed in the control line system.

1x COVID-19, Coronavirus Home Use, Self
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1 Home Use Self Test
Home Use, At Home, Home Testing, Self Testing Antibody Test Kits for COVID-19, Coronavirus, CE CERTIFIED
6 At Home Use Self Tests
Home Use, At Home, Home Testing, Self Testing, 10 Minute, Rapid Antibody Test Kits for COVID-19, Coronavirus, CE CERTIFIED
12 Home Testing Self Tests
At Home Self Testing Antibody Test Kits for COVID-19, Coronavirus, CE Certificate
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Covid-19 Coronavirus IgG IgM Rapid Antibody Test Kit

Self-Testing, Home Use, At Home Antibody Test Kit CE-IVD

"serology test" "serologic testing" or "serological diagnostics"

For professional use only

Box contents

25 Tests Covid-19, Coronavirus Antibody Tests

1 English Instructions

Items Required

  • Alcohol swab

  • Lancet (pin prick)

  • Dropper Pipette

  • Timer 

  • 365nm flashlight to verify test results

Intended use
The 2019-nCoV SARS COV 2, (COVID-19) IgG/IgM Combined Rapid Antibody Test Cassette for COVID-19
 is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies for novel Coronavirus  in human whole blood, serum or plasma specimen. The test is able to detect the different stage of Coronavirus or whether the person has had a past COVID-19 infection. 

The rapid antibody serology test detects both the IgM & IgG antibodies in human finger-prick or venous whole blood, serum, and plasma samples to determine the various stage of the COVID-19 Coronavirus infection.

 

Unlike PCR tests that detect COVID-19 Coronavirus for a brief time window of critical infection, the serology rapid IgG / IgM antibody tests are able to detect COVID-19 antibodies for an extended period of time after the Coronavirus infection and enables the test to detect prior infection.

​​

Warning & Precaution

Samples for human serum, plasma or whole blood should be considered as potentially infectious. The operator should wear protective clothing, masks, and gloves and take other appropriate safety precautions to avoid or reduce the risk of infection before carrying out any tests.

 

Storage Conditions

The test cassette should be stored at 2 - 30 degrees centigrade.  The shelf life is up to 12 months or as indicated on the test cassette. The test card which is sealed inside the aluminium foil bag should be used within 1 hour of opening.

Test Procedure

  • Wear protected equipment before beginning test

  • Massage tip of ring finger (next to little finger on left hand) for few seconds

  • Wipe tip of ring finger with an alcohol swab

  • Use a lancet (pin prick) to prick finger and pierce the skin

  • Squeeze finger to draw a little blood sample

  • Wipe the finger again with an alcohol swab

  • Tear open the sealed foil case for the test cassette

  • Place the test cassette on a table or flat surface

  • Squeeze finger for few seconds to draw a little blood sample for a few drops

  • Use a pipette / dropper to draw 30 ul of blood sample (2 drops of blood) avoiding air bubbles

  • Hold the dropper upright and release the blood sample from the dropper onto the rapid test cassette cartridge specimen well marked S

  • Set timer for 12 minutes

  • Thereafter, immediately, shine a 365nm flashlight on top of test cassette to display and read test cassette results

  • Take a clear photo of test results with a smartphone for later verification

  • Read the test results from smart phone photo (or test cassette immediately)

  • Do not read or interpret results after 20 minutes

  • For health & safety dispose of the lancet, gloves, foil packaging and test cassette in bin

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What is IgM & IgG ?

IgM is the first antibody to appear in the acute infection stage caused by pathogens such as SARS CoV-2, and can normally be detected 3 days after the onset of symptoms.

 

IgG is produced in the middle or later stage of the infection but provides long term protection.

 

In the latest 7th edition of the Diagnosis and Treatment Guideline on the Novel Coronavirus Disease (COVID-19), the SARS-CoV 2 IgG/IgM test is recommended as an aid in the diagnosis of the COVID-19.


SARS-CoV-2 IgG/IgM Kit is used for rapid and accurate screening of the COVID-19, which helps identify suspected patients and reduce false negative rate.


Rapid detection of recent SARS-CoV-2 infection


● In ONLY 12 minutes
● ONE-STEP operation
● Single cartridge, NO additional buffers
● TRFIA Europium particles displays Clear and Bright results
● Dual capturing antigens (S and N) enhanced sensitivity

Important

This test kit is a complement to PCR detection in COVID-19 diagnosis

 

Reagents
The test contains anti-human IgM and anti-human IgG as the capture reagent, 2019-nCoV antigen as the detection reagent. A goat anti-mouse IgG is employed in the control line system.

How to Interpret Results

 NEGATIVE 

C - Denotes the control line and when this is highlighted on its own in red it indicates a negative result, INDICATES NO COVID-19 & NO CORONAVIRUS

 POSITIVE 

C with IgG & IgM denotes a positive result for IgG & IgM

INDICATES SECONDARY COVID-19 INFECTION

C with IgM denotes positive result for IgM

INDICATES PRIMARY COVID-19 INFECTION

C with IgG denoted positive result for IgG

INDICATES PAST COVID-19 INFECTION

 INVALID 

The absence of C with either of the following IgG, IgM, IgG+IgM, or no IgG & no IgM 

INDICATES INVALID OR INCONCLUSIVE TEST -  EXPERIMENT HAD FAILED

This may be due to a number of factors including not enough blood sample, blood sample includes air bubbles, not correct or correct amount of buffer fluid inside the sample tray, reading the results too early  or after 20 minutes have passed or giving rise to inconclusive results.

Sars Cov2 Covid-19 Coronavirus IgG IgM R

 

 

 

Covid-19 Coronavirus IgG IgM Rapid Antibody Test Kit

Self-Testing, Home Use, At Home Antibody Test Kit CE-IVD

"serology test" "serologic testing" or "serological diagnostics"

For professional use only

Box contents

25 Covid-19, Coronavirus Antibody Tests

25 Droppers pipettes

1   Bottle buffer / diluent fluid

1   English user manual with step by step instructions.

Items required

  • Alcohol swabs

  • Lancets (pin prick)

  • Timer

 

Intended use
The 2019-nCoV SARS COV 2, (COVID-19) IgG/IgM Combined Rapid Antibody Test Cassette for COVID-19
 is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies for novel Coronavirus  in human whole blood, serum or plasma specimen. The test is able to detect the different stage of Coronavirus or whether the person has had a past COVID-19 infection. 

The rapid antibody serology test detects both the IgM & IgG antibodies in human finger-prick or venous whole blood, serum, and plasma samples to determine the various stage of the COVID-19 Coronavirus infection.

 

Unlike PCR tests that detect COVID-19 Coronavirus for a brief time window of critical infection, the serology rapid IgG / IgM antibody tests are able to detect COVID-19 antibodies for an extended period of time after the Coronavirus infection and enables the test to detect prior infection.

 

Warning & Precaution

Samples for human serum, plasma or whole blood should be considered as potentially infectious. The operator should wear protective clothing, masks, and gloves and take other appropriate safety precautions to avoid or reduce the risk of infection.

 

Storage Conditions

The test cassette should be stored at 2 - 30 degrees centigrade, and the shelf life is 24 months. The test card which is sealed inside the aluminium foil bag should be used within 1 hour of opening.

Test Procedure

  • Wear protected equipment before beginning test

  • Massage tip of ring finger (next to little finger on left hand) for few seconds

  • Wipe tip of ring finger with an alcohol swab

  • Use a lancet (pin prick) to prick finger and pierce the skin

  • Squeeze finger to draw a little blood sample

  • Wipe the finger again with an alcohol swab

  • Tear open the sealed foil case for the test cassette

  • Place the test cassette on a table or flat surface

  • Squeeze finger for few seconds to draw a little blood sample for a few drops

  • Use a pipette / dropper to draw 20 ul of blood sample (1 full drop of blood) avoiding air bubbles

  • Hold the dropper upright and release the 10ul blood into cassette cartridge specimen well

  • Then add 80ul (2 drops) of buffer / diluent fluid into the test cassette specimen well

  • Set timer for 10 minutes and wait for the coloured lines on the test cassette to appear

  • Take photo of test results with a smartphone for later verification

  • Read the test results from the test cassette in 10- minutes or later from the smart phone photo

  • Do not interpret the results after 20 minutes

  • For health & safety dispose of the lancet, gloves, foil packaging and test cassette in bin

  • Do not use the buffer after 6 months of opening

How to Interpret Results

 NEGATIVE 

C - Denotes the control line and when this is highlighted on its own in red it indicates a negative result, INDICATES NO COVID-19 & NO CORONAVIRUS

 POSITIVE 

C with IgG & IgM denotes a positive result for IgG & IgM

INDICATES SECONDARY COVID-19 INFECTION

C with IgM denotes positive result for IgM

INDICATES PRIMARY COVID-19 INFECTION

C with IgG denoted positive result for IgG

INDICATES PAST COVID-19 INFECTION

 INVALID 

The absence of C with either of the following IgG, IgM, IgG+IgM, or no IgG & no IgM 

INDICATES INVALID OR INCONCLUSIVE TEST -  EXPERIMENT HAD FAILED

This may be due to a number of factors including not enough blood sample, blood sample includes air bubbles, not correct or correct amount of buffer fluid inside the sample tray, reading the results too early  or after 20 minutes have passed or giving rise to inconclusive results.

What is IgM & IgG ?

IgM is the first antibody to appear in the acute infection stage caused by pathogens such as SARS CoV-2, and can normally be detected 3 days after the onset of symptoms.

 

IgG is produced in the middle or later stage of the infection but provides long term protection.

 

In the latest 7th edition of the Diagnosis and Treatment Guideline on the Novel Coronavirus Disease (COVID-19), the SARS-CoV 2 IgG/IgM test is recommended as an aid in the diagnosis of the COVID-19.


SARS-CoV-2 IgG/IgM Kit is used for rapid and accurate screening of the COVID-19, which helps identify suspected patients and reduce false negative rate.

Important

This test kit is a complement to PCR detection in COVID-19 diagnosis

 

Reagents
The test contains anti-human IgM and anti-human IgG as the capture reagent, 2019-nCoV antigen as the detection reagent. A goat anti-mouse IgG is employed in the control line system.

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Coronavirus Covid-19 IgG IgM Rapid Antib

 

 

 

Covid-19 Coronavirus IgG IgM Rapid Antibody Test Kit

Self-Testing, Home Use, At Home Antibody Test Kit CE-IVD

"serology test" "serologic testing" or "serological diagnostics"

For professional use only

Box Contents

25 Covid-19 Antibody Tests

25 dropper’s / pipettes

1 bottle buffer / diluent fluid

1 User instructions plain, easy to understand English

 

YouTube video will follow shortly

 

Items required

  • Alcohol swabs (check our online store for pack of 25 swabs)

  • Lancet / pin prick (check our online store for pack of 25lancets / pin pricks)

  • Timer

Intended use
The 2019-nCoV SARS COV 2, (COVID-19) IgG/IgM Combined Rapid Antibody Test Cassette for COVID-19
 is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies for novel Coronavirus  in human whole blood, serum or plasma specimen. The test is able to detect the different stage of Coronavirus or whether the person has had a past COVID-19 infection. 

The rapid antibody serology test detects both the IgM & IgG antibodies in human finger-prick or venous whole blood, serum, and plasma samples to determine the various stage of the COVID-19 Coronavirus infection.

 

Unlike PCR tests that detect COVID-19 Coronavirus for a brief time window of critical infection, the serology rapid IgG / IgM antibody tests are able to detect COVID-19 antibodies for an extended period of time after the Coronavirus infection and enables the test to detect prior infection.

Warning & Precaution

Samples for human serum, plasma or whole blood should be considered as potentially infectious. The operator should wear protective clothing, masks, and gloves and take other appropriate safety precautions to avoid or reduce the risk of infection.

 

Storage Conditions

The test cassette should be stored at 2 - 30 degrees centigrade, and the shelf life is 12 months. The test card which is sealed inside the aluminium foil bag should be used within 1 hour of opening.

Test Procedure

  • Wear protected equipment before beginning test

  • Massage tip of ring finger (next to little finger on left hand) for few seconds

  • Wipe tip of ring finger with an alcohol swab

  • Use a lancet (pin prick) to prick finger and pierce the skin

  • Squeeze finger to draw a little blood sample

  • Wipe the finger again with an alcohol swab

  • Tear open the sealed foil case for the test cassette

  • Place the test cassette on a table or flat surface

  • Squeeze finger for few seconds to draw a little blood sample for a few drops

  • Use a pipette / dropper to draw 10 ul of blood sample (1 full drop of blood) avoiding air bubbles

  • Hold the dropper upright and release the 10 ul blood into cassette cartridge specimen well

  • Then add 80ul (2 drops) of buffer / diluent fluid into the test cassette specimen well

  • Set timer for 12 minutes and wait for the coloured lines on the test cassette to appear

  • After 12 minutes take photos of test results with a smartphone for later verification

  • Read and interpret the test results from the test cassette  within 15 minutes of starting the test or later from the photos taken on your smart phone

  • Do not interpret the results after 20 minutes

  • For health & safety dispose of the lancet, gloves, foil packaging and test cassette in bin

  • Do not use the buffer after 6 months of opening

How to Interpret Results

 NEGATIVE 

C - Denotes the control line and when this is highlighted on its own in red it indicates a negative result, INDICATES NO COVID-19 & NO CORONAVIRUS

 POSITIVE 

C with IgG & IgM denotes a positive result for IgG & IgM

INDICATES SECONDARY COVID-19 INFECTION

C with IgM denotes positive result for IgM

INDICATES PRIMARY COVID-19 INFECTION

C with IgG denoted positive result for IgG

INDICATES PAST COVID-19 INFECTION

 INVALID 

The absence of C with either of the following IgG, IgM, IgG+IgM, or no IgG & no IgM 

INDICATES INVALID OR INCONCLUSIVE TEST -  EXPERIMENT HAD FAILED

This may be due to a number of factors including not enough blood sample, blood sample includes air bubbles, not correct or correct amount of buffer fluid inside the sample tray, reading the results too early  or after 20 minutes have passed or giving rise to inconclusive results.

What is IgM and IgG ?

IgM is the first antibody to appear in the acute infection stage caused by pathogens such as SARS CoV-2, and can normally be detected 3 days after the onset of symptoms.

 

IgG is produced in the middle or later stage of the infection but provides long term protection.

 

In the latest 7th edition of the Diagnosis and Treatment Guideline on the Novel Coronavirus Disease (COVID-19), the SARS-CoV 2 IgG/IgM test is recommended as an aid in the diagnosis of the COVID-19.


SARS-CoV-2 IgG/IgM Kit is used for rapid and accurate screening of the COVID-19, which helps identify suspected patients and reduce false negative rate.


Important

This test kit is a complement to PCR detection in COVID-19 diagnosis

 

Reagents
The test contains anti-human IgM and anti-human IgG as the capture reagent, 2019-nCoV antigen as the detection reagent. A goat anti-mouse IgG is employed in the control line system.

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