PROFESSIONAL USE ONLY

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

ACCURACY OVER 95%²

HSA 600:36/01
European CE Marking
(DE/CA70/40838-154686)

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.

DOCUMENTS FOR DOWNLOAD

OUR METHOD

	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.

PEER COMPARISON

	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

TEST PROCEDURE AND INTERPRETATION

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.

FREQUENTLY ASKED QUESTIONS

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

INTENDED USE

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.

LIMITATIONS

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

PRE-PRINTS AND PEER-REVIEWED PUBLICATIONS

Dynamic profile for the detection of anti-SARS-CoV-2 antibodies using four immunochromatographic assays

Baptiste Demey^a,b, Nagib Daher^c , Catherine François^a,b, Jean-Philippe Lanoix^b,d, Gilles Duverlie^a,b, Sandrine Castelain^a,b, Etienne Brochot^a,b, ∗

Department of Virology, Amiens University Medical Center, Amiens, France
AGIR Research Unit, EA4294, Jules Verne University of Picardie, Amiens, France
Department of Gynecology-Obstetrics, University Hospital, Amiens
Infectious Diseases Department, University Hospital, Amiens

Analytical performance of lateral flow immunoassay for SARS-CoV-2 exposure screening on venous and capillary blood samples

Margaret A. Black, MD¹*, Guomiao Shen, PhD^1*, Xiaojun Feng, PhD^1*, Wilfredo F. Garcia, Beltran, MD, PhD^3,4, Yang Feng, PhD², Varshini Vasudevaraja, MS¹, Douglas Allison, MD¹, Lawrence H. Lin, MD, PhD¹, Tatyana Gindin MD, PhD¹, Michael Astudillo, MD³, Diane Yang, PhD³, Mandakolathur Murali, MD^3,5, A. John Iafrate, MD, PhD³, George Jour, MD^1**, Paolo, Cotzia, MD^1**, Matija Snuderl, MD^1**

Department of Pathology, NYU Langone Health, New York City, NY
Department of Biostatistics, NYU School of Global Public Health, New York City, NY
Department of Pathology, Massachusetts General Hospital and Harvard Medical School, Boston, MA
Ragon Institute of MGH, MIT, and Harvard, Cambridge, MA
Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA

* These authors contributed equally to this work.
** Corresponding authors

Singapore’s Response to Covid-19

Abstract This chapter will discuss Singapore’s response to the Covid-19 pandemic, focusing in particular on how it has mobilised and adapted its policy capacities to deal with the pandemic. I will also discuss the new capacities that were established this period. In focusing on how policy capacities were drawn upon or created in its Covid-19 response, this chapter will provide readers with an understanding of the various policy capacities that are necessary for responding to pandemics and other healthcare crises, as well as the capacity limitations or deficiencies that may have posed challenges for policymakers.

Keywords Covid-19 · Singapore · Pandemic response · Policy capacity

Evaluation of Six Commercial Mid- to High-Volume Antibody and Six Point-of-Care Lateral Flow Assays for Detection of SARS-CoV-2 Antibodies

iDCarmen L. Charlton,^a,b,c Jamil N. Kanji,^a,d Kam Johal,a Ashley Bailey,^a Sabrina S. Plitt,^e Clayton MacDonald,^a,b Andrea Kunst,^fEmily Buss,^f Laura E. Burnes,^a,b Kevin Fonseca,^a,g Byron M. Berenger,^a,h Kareena Schnabl,^b,f Jia Hu,^i,j William Stokes, ^k Nathan Zelyas,^a,b Graham Tipplesa,^c,l

Evaluating ten commercially-available SARS-CoV-2 rapid 3 serological tests using the STARD (Standards for 4 Reporting of Diagnostic Accuracy Studies) method.

Laurent DORTET,^1,2,$ Jean-Baptiste RONAT,^2,3,$ Christelle VAULOUP-FELLOUS,^4,5$Céline LANGENDORF,⁶ David-Alexis MENDELS,⁷ Cécile EMERAUD, ^1,2 Saoussen OUESLATI,² Delphine GIRLICH,² Anthony CHAUVIN,⁸ Ali AFDJEI⁹ , Sandrine BERNABEU,^1,2 Samuel LE PAPE,⁴ Rim KALLALA, ⁴ Alice ROCHARD,² Celine VERSTUYFT,¹⁰ Nicolas FORTINEAU,^1,2 Anne-Marie ROQUE-AFONSO,^4,5 and Thierry NAAS^1,2*

2019-nCoV IgG/IgM ANTIBODY DETECTION KIT