2019-nCoV IgG/IgM Antibody Detection Kit
(Colloidal Gold)

  • High sensitivity, specificity & conformity
  • Compatible with serum/plasma/venous whole blood1
  • Simultaneous detection of SARS-CoV-2 specific IgM and IgG antibodies

  • HSA 600:36/01
  • European CE Marking

1 Not recommended for finger prick test. Validations were performed on venous whole blood, serum and plasma.

2 Venous whole blood and serum specimens were tested using the 2019-nCoV IgG/IgM Detection Kit and results were compared to clinical diagnosis.




  RT-PCR Antigen Rapid Test IgG/IgM
Rapid Test
Detection Substance Nucleic Acid Virus Antigen IgG/IgM
antibodies against virus
Sample Type Nasopharyngeal Swabs/ Sputum/ Alveolar/ Lavage Fluid Nasopharyngeal Swabs/ Sputum Serum/Plasma/
Venous Whole Blood
Result Time 2 hours 10-15 minutes 10 minutes
Instrument(s) Required Required Not Required Not required
Laboratory Requirements High Average Average
Product Usage and comments Confirming Diagnosis Diagnostic Support Tool alongside epidemiology checks (temperature checks, health questionaires etc)
The 2019-nCov IgG/IgM Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of IgG & IgM antibody of Coronavirus in human venous whole blood, serum or plasma.


  BIOLIDICS Product A Product B Product C Product D Product E
Time to Results 10 minutes 10 minutes 10 minutes 10 minutes 10 minutes 10 minutes
Sample Types Serum / Plasma / Venous Whole blood   Serum / Plasma / Venous Whole Blood Serum / Plasma / Venous Whole Blood Serum / Plasma / Venous Whole Blood Serum / Plasma / Venous Whole Blood Serum / Plasma / Venous Whole Blood
Clinical Sensitivity 91.54% 90.2% 87.3% >90% 86.43% 97.9%
Clinical Specificity 97.02% 99.2% 100% >90% 99.57% 91.77%
Conformity 95.09% 95.2% Not Available Not Available 91.61% Not Available
Certifications CE Marking submission/Health Science Authority (SG)/Philippines FDA NMPA/CE marking NMPA/CE marking CE Marking/FDA-EUA submission NMPA/CE marking FDA-EUA submission


Intended Samples for Testing Human Serum Plasma Venous Whole Blood
Collection Tube
Plain tube with or without gel (5mL)
Heparin Sodium or EDTA Anticoagulant blood tube (3mL)
EDTA Anticoagulant blood tube (3mL)
Storage Conditions Serum/plasma stored at
2-8°C ; 7 days
minus 20°C(frozen) and below; 24 days
Venous whole blood must be tested immediately
Other Important Notes
  • Specimens must be collected using standard phlebotomy protocol.
  • Room temperature (18°C – 28°C) before processing.
  • Frozen samples must be completely thawed and mixed well before testing.
  • If particulates are visible, centrifuge at 3000g for 10 min
  • No repeated thawing and freezing.

Haemolysed or hyperlipidaemic blood samples should not be tested using our 2019-nCoV IgG/IgM Antibody Detection Kit.

Results* Interpretation**
IgM +VE, IgG +VE Suspected recent infection of SARS-CoV-2
IgM +VE, IgG –VE Suspected recent infection of SARS-CoV-2
IgM –VE, IgG +VE Patient suspected to have past infection
IgM –VE, IgG –VE IgG/IgM antibodies for SARS-CoV-2 undetected OR antibody level below limit of detection

* Results should only be evaluated if the C band is present. If it is absent, the test must not be evaluated and has to be discarded. A retest of the sample will be required.

** This test is intended to be an aid in identifying patients with antibodies to SARS-CoV-2. Positive IgG and/or IgM results indicates a recent or prior infection. This test is not intended for use to diagnose acute SARS-CoV-2 infection and direct testing should be performed for diagnosis.


  1. What are the different types of tests and how are they different?
    There are two main types of tests to detect the SARS-CoV-2 virus: Molecular and Serological. A molecular test detects the RNA, which is the virus’ genetic material. A serological test detects proteins, called antibodies, that are produced by the immune system in response to an infection.

  2. When do antibodies to SARS-CoV-2 surface?
    Upon an infection, the production of IgM and IgG by the human body occurs at different time points. The IgM antibodies are usually produced in the early to mid-stages of an initial infection, whereas, the IgG antibodies are present in the mid to late-stages of an infection, and after recovery as well.

  3. Who should perform the test?
    Only professionally trained operators are required to carry out the test.

  4. Where can this test be carried out?
    In primary care clinics, hospitals, or other designated healthcare facilities. It is not intended for testing outside of healthcare settings, such as home.

  5. Can I purchase a test for my personal use at home?
    No. Only professionally trained operators can carry out the test under approved medical settings.

  6. What is the difference between Sensitivity, Specificity and Accuracy?
    The terms "Sensitivity", "Specificity" and "Accuracy" refer to the different statistical parameters used in describing the performance of a test. The accuracy of a medical test is determined by the sensitivity and specificity of the test.

    Sensitivity measures the number of patients, who have developed the antibodies against SARS-CoV-2, have been correctly identified as a patient infected with SARS-CoV-2 (also known as “true positive” rate).

    Specificity measures the number of patients, who have not developed the antibodies against SARS-CoV-2, have been correctly identified as an uninfected patient of SARS-COV-2 (also known as “true negative” rate).

    Accuracy, or Conformity, is the proportion of true results, either true positive or true negative, in a group of patients who has been tested


The 2019-nCoV IgG/IgM Antibody Detection Kit (Colloidal Gold) is intended for the qualitative detection of IgG/IgM antibodies against SARS-CoV-2 in human serum, plasma, and venous whole blood collected in clinical laboratories and/or by healthcare workers at the point-of-care.

The results from this test should not be used as the sole basis to diagnose, exclude SARS-CoV-2 infection and/or to inform infection status. The results will have to be interpreted together with clinical presentation and are to be confirmed with supplemental testing (e.g. RT-PCR).

The kit is not intended for finger-prick testing, in-home testing or screening donated blood.


  • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out other infections in these individuals.
  • Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.
  • This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens


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