
COVID-19 IgG/IgM Rapid Test Device (WB/S/P)
COVID-19 IgG/IgM Rapid Test Device by LARKSOIS Pharma is an infectious disease rapid test designed for the qualitative detection and differentiation of IgG and IgM antibodies to SARS-CoV-2 in whole blood, serum, or plasma specimens. This COVID-19 IgG/IgM Rapid Test Device supports professional antibody screening and helps identify immune response related to past or recent exposure to COVID-19.
Description
COVID-19 IgG/IgM Rapid Test Device (WB/S/P)
Category
INFECTIOUS DISEASE
Method
Rapid Test
Cut-Off
N/A
Introduction
- The COVID-19 IgG/IgM Rapid Test Device is a professional infectious disease rapid test used for qualitative detection and differentiation of IgG and IgM antibodies to SARS-CoV-2.
- This rapid antibody test is designed for whole blood, serum, or plasma specimens.
- The test helps identify immune response related to past or recent exposure to COVID-19.
- Results should be interpreted with clinical history, symptoms, exposure history, and local healthcare guidance.
What Is Covid Ag Test
The COVID-19 IgG/IgM Rapid Test Device is a rapid antibody test that helps detect two antibody classes: IgM antibodies and IgG antibodies. IgM antibodies are often considered early-response antibodies, while IgG antibodies usually appear later and may remain detectable longer than IgM.
Importance
- The COVID-19 IgG/IgM Rapid Test Device can support antibody screening in professional healthcare settings.
- It may help evaluate whether a person has developed an immune response to SARS-CoV-2.
- This test may be useful for antibody screening programs, serological surveillance, research, epidemiological studies, and post-infection immune response assessment.
- Antibody tests should not be used alone to diagnose or exclude active COVID-19 infection.
Intended Use
The COVID-19 IgG/IgM Rapid Test Device by LARKSOIS Pharma may be used in professional diagnostic and healthcare screening environments.
Applications
- Antibody screening programs
- Serological surveillance
- Research and epidemiological studies
- Post-infection immune response assessment
- Healthcare and laboratory screening support
- Hospitals and clinics
- Diagnostic centers and laboratories
- Public health studies
- International diagnostic supply programs
How It Works
- The COVID-19 IgG/IgM Rapid Test Device works on a lateral flow immunochromatographic assay principle.
- The specimen moves across the membrane by capillary action.
- If SARS-CoV-2 IgG or IgM antibodies are present, they bind with coated test components and form visible colored lines.
- A control line confirms valid sample flow and proper test performance.
Method
The COVID-19 IgG/IgM Rapid Test Device uses rapid lateral flow immunochromatographic technology for qualitative detection and differentiation of SARS-CoV-2 IgG and IgM antibodies from whole blood, serum, or plasma specimens.
Benefits
- Qualitative detection of SARS-CoV-2 IgG antibodies
- Qualitative detection of SARS-CoV-2 IgM antibodies
- Differentiates IgG and IgM antibody response
- Suitable for whole blood, serum, or plasma specimens
- Simple visual result interpretation
- No major instrument required
- Supports professional antibody screening workflows
- Suitable for international diagnostic supply
Specimen
The COVID-19 IgG/IgM Rapid Test Device is designed for whole blood, serum, or plasma specimens. Correct specimen collection and handling are important for reliable screening performance.
Guidance
- Use approved whole blood, serum, or plasma specimens only
- Collect specimens according to the product insert
- Use clean and suitable sample collection materials
- Avoid contaminated or improperly stored samples
- Add the required specimen volume according to the kit insert
- Add buffer as instructed
- Read results only within the recommended time window
- Handle all blood specimens as potentially infectious material
Note
Specimen collection, handling, testing, timing, and storage should always follow the official LARKSOIS Pharma kit insert.
Cut Off
The COVID-19 IgG/IgM Rapid Test Device by LARKSOIS Pharma is designed to detect and differentiate SARS-CoV-2 IgG and IgM antibodies in whole blood, serum, or plasma specimens. It does not directly detect the virus itself; instead, it detects antibodies produced by the immune system after exposure or infection.
Clinical Importance
- COVID-19 IgG/IgM antibody testing can support professional antibody screening and immune response evaluation.
- IgM positive results may suggest an early or recent immune response, but clinical history and confirmatory testing are important.
- IgG positive results may suggest past exposure, later-stage immune response, or recovery phase.
- Healthcare professionals should interpret results with symptoms, exposure history, vaccination status, medical history, and other test findings.
Limitations
The COVID-19 IgG/IgM Rapid Test Device is intended as a qualitative antibody screening aid and should not be used as the only basis for diagnosis, treatment, isolation, or public health decisions.
Instructions
- Antibody tests do not directly detect the virus itself
- A negative antibody result cannot rule out active COVID-19
- Antibody levels may be low during early infection
- Performance depends on specimen quality and timing after infection
- Immune response may vary between individuals
- Improper testing procedure may affect results
- Results should be interpreted with clinical history and other findings
- Direct virus testing may be required if acute infection is suspected
Key Features
Instructions
- Qualitative detection and differentiation of IgG and IgM antibodies
- Suitable for whole blood, serum, or plasma specimens
- Simple visual result interpretation
- No major instrument required
- Supports antibody screening workflows
- Useful for hospitals, clinics, laboratories, and public health studies
- Designed for professional in-vitro diagnostic use
- Suitable for international diagnostic supply
Note
The COVID-19 IgG/IgM Rapid Test Device by LARKSOIS Pharma is developed for professional users who need practical antibody screening support.
Procedure
Steps
- Bring the test device and specimen to room temperature
- Remove the test cassette from the sealed pouch
- Place the cassette on a clean, flat surface
- Add the required amount of whole blood, serum, or plasma
- Add buffer as instructed
- Wait for the recommended reaction time
- Read the IgG, IgM, and control lines within the stated time window
- Do not interpret the result after the recommended reading time
- Dispose of used materials according to laboratory safety rules
Note
Testing should be performed by trained professionals according to the official LARKSOIS Pharma product insert.
Result Interpretation
Positive
IgM positive / IgG negative may suggest an early immune response. IgG positive / IgM negative may suggest past exposure, later-stage immune response, or recovery phase. IgM positive / IgG positive may indicate recent or ongoing immune response.
Negative
IgM negative / IgG negative means no detectable IgM or IgG antibodies were found. This does not fully rule out infection, especially if testing is done too early.
Invalid
If the control line does not appear, the result is invalid and should be repeated using a new device according to the product insert.
Storage
Instructions
- Store the test device according to the product label and package insert
- Store in a dry place
- Keep sealed until use
- Do not freeze
- Avoid direct sunlight
- Keep away from moisture
- Do not use expired kits
- Use immediately after opening the pouch
Precautions
Instructions
- For professional in-vitro diagnostic use only
- Handle all blood specimens as potentially infectious
- Wear gloves and follow biosafety practices
- Do not reuse the test cassette
- Do not use damaged or expired devices
- Avoid specimen cross-contamination
- Read results only within the recommended time
- Confirm results where clinically required
Why Choose
LARKSOIS Pharma provides international-quality diagnostic products for hospitals, laboratories, clinics, public health buyers, distributors, and importers. The COVID-19 IgG/IgM Rapid Test Device is designed for practical antibody screening using whole blood, serum, or plasma.
Advantages
- International diagnostic product focus
- Reliable rapid testing solutions
- Suitable for hospitals, clinics, and laboratories
- Distributor-friendly product format
- Supports antibody screening workflows
- Practical WB/S/P testing format
- Quality-focused standards under LARKSOIS Pharma
Frequently Asked Questions
What does IgG positive and IgM negative mean?+-
IgG positive and IgM negative may indicate past exposure or a later-stage immune response to SARS-CoV-2. It does not confirm active infection by itself and should be interpreted with clinical history.
What is COVID-19 IgG?+-
COVID-19 IgG is an antibody produced by the immune system after exposure to SARS-CoV-2. IgG usually appears later than IgM and may remain detectable for a longer period.
How long do COVID IgM antibodies last?+-
COVID-19 IgM antibodies may appear during the early immune response and usually decline over time. Duration varies between individuals, infection severity, vaccination status, and immune response.
How long is IgM positive for?+-
IgM positivity can last for weeks in some people, but the exact duration varies. A positive IgM result should be interpreted with symptoms, exposure history, and other test findings.
Is high IgM serious?+-
High IgM may suggest a recent immune response, but it is not automatically serious. Clinical interpretation depends on symptoms, medical history, and confirmatory testing by a healthcare professional.
