Instructions - Covid-19 Rapid Antibody IgG IgM Test Kits

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

 

 

 

 

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.

Coronavirus Covid-19 IgG IgM Rapid Antib
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