SRAM-Acco COVID 19 lgM/lgG Rapid Diagnostic test kit for Diagnosing

Coronavirus disease 2019 (COVID-19)

SRAM MRAM Technologies in association with its group company AccoBiotech Sdn Bhd (Malaysia) has developed Rapid Diagnostic test kit for novel coronavirus COVID-19 infection. This test detects qualitatively both early marker and late marker, IgM/IgG antibodies of the novel coronavirus in human serum, plasma or whole blood in vitro.

SRAM Acco Covid19 Rapid Testing Kit

About SRAM-Acco COVID-19 IgM/IgG device

SRAM-Acco COVID-19 IgM/IgG device is a chromatographic immunoassay kit for the rapid and differential detection of immunoglobulin M (lgM) and immunoglobulin G (IgG) against COVID-19 using serum, plasma and whole blood.

  • Accurate Test Results: Within 15 minutes
  • Sensitivity: 95% or more
  • Specificity: 99%
  • Rapid screening of carriers of virus that are symptomatic or asymptomatic
  • Easy & Efficient: Intuitive visual interpretation, No special equipment needed
  • Test Purpose: Clinical Diagnostic use, ideally suited for hospitals, clinics, laboratories
SRAM-Acco COVID-19 IgM/IgG device
Acco COVID-19 IgM/IgG

SRAM-Acco COVID 19 lgM/lgG Rapid Diagnostic test kit - Diagnosis in 10-15 minutes

It is widely accepted that IgM provides the first line of defense during viral infections, followed by the generation of adaptive, high affinity IgG responses for long term immunity and immunological memory. Therefore testing of COVID-19 IgM and IgG antibodies is an effective method for the rapid diagnosis of COVID-19 infection. Furthermore, detection of COVID-19 IgM antibodies tends to indicate a recent exposure to COVID-19, whereas detection of COVID-19 IgG antibodies indicates a later stage of infection. Thus, this combined antibody test could also provide information on the stage of infection.

SRAM-Acco COVID 19 lgM/lgG Rapid Diagnostic test kit

Display- Results/Expected Values:immunochromatography based

A total of three detection lines are possible, with the control (C) line appearing when sample has been flowed through the cassette.

1 ) Negative Result : If only the quality control line (C) appears and the detection lines G and M are not visible, then no novel coronavirus antibody has been detected . Result is negative.

2 ) Positive Result, M only : If both the quality control line (C) and the detection line M appears, then the novel coronavirus IgM antibody has been detected .Result is positive for the IgM antibody.

3 ) Positive Result, G only: If both the quality control line (C) and the detection line G appears, then the novel coronavirus IgG antibody has been detected. Result is positive for the IgG antibody.

4 ) Positive Result, G and M:• If the quality control line (C) and both detection lines G and M appear, then the novel coronavirus
PS: IgG and IgM antibodies have been detected. Result is positive for both the IgG and IgM antibodies

Diagnostic Accuracy of Acco COVID-19 IgM/IgG

Diagnostic Accuracy of Acco COVID-19 IgM/IgG

Parameters Performance (Ongoing) Comments
Analytical sensitivity 1.84 s/CO for IgM
1.57 s/CO for IgG
w. ELISA
Sensitivity Day 3 after symptom: IgM- 30%, IgG- 0%
After Day 7 from symptom: IgM- 80%, IgG->95%
w. limited cases
Specificity IgM 98% (118/120), IgG: 99% (119/120)  

Interpretation Method

Molecular test Antibody test Interpretation
IgM IgG
Positive Negative Negative Acute infection (D1 ~ D3)
Positive Positive Negative Acute infection (D3 ~ D8)
Positive Positive Positive Infected (D8 ~ D15)
Positive Negative Positive Infected (>D15) or secondary infected
Negative Positive Negative Early stage of infection. Need the additional molecular test
Negative Positive Positive Infection (D8~D15), Need the additional molecular test
Negative Negative Positive Passed infection or(if IgG negative change to IgG positive) infected
Negative Negative Negative Not infected

Comparison With Molecular Testing

Molecular Testing (RT-PCR) Acco COVID-19 IgG/IgM Rapid Test
Principle Nucleic acid test of COVID-19 Antibody (IgM & IgG) detection in the blood
Accuracy in the fields -China: 30 ~ 50% (Jungangilbo.2020.02.13)
-Depending on the swab positioning of specimen and yield of gene extraction
-Before Day 5: very low
-After Day 5: 50~81% for IgM, 81~100% for IgG
Test time >6 hours 10 minutes
Test cost Very expensive Economic
Users Skilled & trained Normal
Specimen Throat, anal, nasopharyngeal, sputum Whole blood, serum, plasma
Test capacity Limited Possible to bulk testing
Adv/disadvantages Good accurate at early stage.
Difficult to detect at latent or asymptomatic period.
Appropriate for early stage with limited cases of patients
Possible to detect at latent or asymptomatic period.
Inaccurate at from Day 0 to Day 5 after infection
Appropriate for 5 day-after with bulk cases of patients

SRAM &MRAM Technologiesis on a novel mission of designing, developing and patenting technologies that are created for the betterment of humanity. With global customers panning across Malaysia, Laos, Cambodia, Penang etc through its 500 + global channel partners in countries of Vietnam, Kazakhstan, Indonesia, India, Philippine, Thailand, Middle East and Africa.

key Facts

1.      SRAM &MRAM Technologies: R & D Facility

a.       First & Only Full Fledge RDT Manufacturing In Malaysia

b.       GMP Status, ISO certified, CE US Patent (No; 9,354,234)

c.       Recognize as BIOTECH company by BIOTECHCORP & MIDA

d.       Ministry of International Trade and Industry: Awarded Manufacturing License for “Diagnostic Test Kits”

2.       Diagnostic Kits:In vitro Diagnosis Test (IVD), Rapid Test Kit (RTK), Point of Care Test (POCT)

3.       Manufacturing Technology: Nano Technology

4.       Production Capacity: minimum of 30,000 kits per day

5.       Technology Innovations: Q-RTK & Microarray Chip etc

6.      R&D Titles:

a.       Identification, evaluation and alleviation of the threat of Vector-borne Rickettsial agents to human health in Malaysia

b.       Rapid measurement of important multiple biomarkers using microcapillary film (MCF), a portable low cost rapid test kit

c.       Development of a novel rapid point-of-care in Vitro Diagnostic Device for detection of HPV and cervical cancer prevention- DNA-based lateral flow assay

d.       Clinical diagnosis of early dengue infection by novel one-step multiplex real-time RT-PCR targeting NS1 gene

e.       IT-POC convergence in cardiac care and to evaluate the efficacy of Rapid test kit in chest pain evaluations in developing countries

For Product Queries, Orders and Business Enquiries:

We are working 24 x 7, serving the global medical facilities reaching out for order and information regarding the SRAM-Acco COVID 19 lgM/lgG Rapid Diagnostic test kit.

Email your queries to salesuk@srammram.com, our team will revert you to asap.

 

SRAM &MRAM Technologies Limited,
Head office:
Lomond Court, Castle Business Park,Stirling, Stirlingshire, FK9 4TU,

United Kingdom.

Email:salesuk@srammram.com