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.
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.
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
|Analytical sensitivity||1.84 s/CO for IgM
1.57 s/CO for IgG
|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)|
|Molecular test||Antibody test||Interpretation|
|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|
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.
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
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