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Access Bio Inc

Access Bio Inc

Access Bio is dedicated to the prevention and early diagnosis of infectious diseases through research, development, and manufacturing of in vitro rapid diagnostic tests, biosensor, and molecular diagnostic products. The company’s core in vitro diagnostic technology includes immunochemical, biochemical and molecular product ...
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Covid-19 Access Bio Inc

Clinical Laboratory

COVID-19 IgM/IgG Assay
CareStart COVID-19 IgM/IgG

The CareStart COVID-19 IgM/IgG is an immunochromatographic lateral flow assay intended for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in human serum, plasma (sodium citrate, sodium heparin, or dipotassium EDTA), venous whole blood (sodium citrate, sodium heparin, or dipotassium EDTA) and fingerstick whole blood.
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COVID 19 IgM/IgG Test
CareStart COVID-19 IgM/IgG

The CareStart COVID-19 IgM/IgG Rapid Diagnostic Test for the Detection of SARS-CoV-2 IgM/IgG Ab provides a fast and easy diagnostic tool for COVID-19 in the limited testing environment. It detects and differentiates IgM/IgG antibody specific to SARS-CoV-2 using a small sample volume of 10 uL of venous whole blood, serum, or plasma) with results available in 10 minutes.
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COVID-19 RT-PCR Test
CareStart COVID-19 MDx RT-PCR

The CareStart COVID-19 MDx RT-PCR is intended for qualitative detection of SARS-CoV-2 RNA in upper respiratory specimens (such as and nasopharyngeal wash/aspirate or nasal aspirate) and bronchoalveolar lavage from individuals suspected of COVID-19 by their healthcare provider. The FDA emergency use authorized test has a processing time of less than 83 minutes and is available for use with the CFX96 system (Bio-Rad Laboratories, Inc.) and Applied Biosystems 7500/7500 Fast Real-Time PCR System (Thermofisher Scientific).
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COVID-19 Antigen Test
CareStart COVID-19 Antigen Test

The CareStart COVID-19 Antigen Test is an intended point-of-care (POC) designated test with a 10 minute processing time that allows effective screening of COVID-19 infection on a large scale. The lateral flow assay provides rapid results in 10 minutes using minimally invasive specimen collection (nasopharyngeal) and is intended for use at POC settings (i.e., in patient care settings) by medical professionals.
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SARS-CoV-2 RT-PCR Test
CareGene N-CoV RT-PCR Kit

The CareGene N-CoV RT-PCR Kit is an in vitro diagnostic medical device for the qualitative detection of COVID-19 from RNA extracted from human Nasopharyngeal swab, Oropharyngeal swab and sputum using Real Time-PCR. It targets two regions of viral RNA (N gene and RdRP gene), with both the reverse transcription (RT) and qPCR step conducted in the same reaction well and has a reaction time of less than 83 minutes.
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Point-Of-Care Testing

COVID-19 IgM/IgG Assay
CareStart COVID-19 IgM/IgG

The CareStart COVID-19 IgM/IgG is an immunochromatographic lateral flow assay intended for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in human serum, plasma (sodium citrate, sodium heparin, or dipotassium EDTA), venous whole blood (sodium citrate, sodium heparin, or dipotassium EDTA) and fingerstick whole blood.
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About Access Bio Inc

Access Bio is dedicated to the prevention and early diagnosis of infectious diseases through research, development, and manufacturing of in vitro rapid diagnostic tests, biosensor, and molecular diagnostic products. The company’s core in vitro diagnostic technology includes immunochemical, biochemical and molecular products.

Recently updated

COVID-19 IgM/IgG Assay
CareStart COVID-19 IgM/IgG

The CareStart COVID-19 IgM/IgG is an immunochromatographic lateral flow assay intended for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in human serum, plasma (sodium citrate, sodium heparin, or dipotassium EDTA), venous whole blood (sodium citrate, sodium heparin, or dipotassium EDTA) and fingerstick whole blood.
More details

HIV 1/2 Rapid Diagnostic Test
CareStart EZ HIV 1/2

The CareStart EZ HIV 1/2 is an in vitro RDT for the qualitative detection of antibodies to HIV type-1 and/or type-2 in serum, plasma, capillary whole blood or venous whole blood. The device is a single-use intended for healthcare professional use as an aid to diagnosis only – not for screening blood donors.
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Flu A&B Rapid Diagnostic Test
Flu A&B Plus

Flu A&B Plus is a qualitative rapid diagnostic test for the reliable detection of all Flu A&B strains. The test requires a specimen volume of 80 μl and has a result time of 10-15 minutes.
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Clinical Laboratory

COVID-19 IgM/IgG Assay
CareStart COVID-19 IgM/IgG

The CareStart COVID-19 IgM/IgG is an immunochromatographic lateral flow assay intended for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in human serum, plasma (sodium citrate, sodium heparin, or dipotassium EDTA), venous whole blood (sodium citrate, sodium heparin, or dipotassium EDTA) and fingerstick whole blood.
More details

HIV 1/2 Rapid Diagnostic Test
CareStart EZ HIV 1/2

The CareStart EZ HIV 1/2 is an in vitro RDT for the qualitative detection of antibodies to HIV type-1 and/or type-2 in serum, plasma, capillary whole blood or venous whole blood. The device is a single-use intended for healthcare professional use as an aid to diagnosis only – not for screening blood donors.
More details

Flu A&B Rapid Diagnostic Test
Flu A&B Plus

Flu A&B Plus is a qualitative rapid diagnostic test for the reliable detection of all Flu A&B strains. The test requires a specimen volume of 80 μl and has a result time of 10-15 minutes.
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Zika Virus RT-PCR
Zika Virus RT-PCR Kit

The Zika Virus RT-PCR Kit features one-step RT-PCR components and is intended to extract RNAs from serum and urine samples using 5μL of specimen volume. The kit has a result time of 90 minutes and can be stored at temperature below -20° with a shelf life of 12 months.
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Dengue Genotyping Kit
Dengue Virus Genotyping Kit

The Dengue Virus Genotyping Kit features one-step RT-PCR components and is intended to extract RNAs from serum using 5μL of specimen volume. The kit has a result time of 90 minutes and can be stored at temperature below -20° with a shelf life of 12 months.
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Neonatal Analyzer
CareStart S1 Analyzer

The CareStart S1 Analyzer is a neonatal solution that is capable of quantifying total G6PD, Hemoglobin, and Bilirubin levels. The analyzer's handheld format along with Bluetooth and other technologies enables patient-side accuracy and convenience.
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Hemoglobin A1c Analyzer
careSURE Analyzer 100

The careSURE Analyzer 100 is a fully automated HbA1c POC analyzer for measuring Hemoglobin A1c using the boronate affinity method. It requires 3 µL of whole blood (capillary and venous) sample and has a test time of three minutes.
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SARS-CoV-2 RT-PCR Test
CareGene N-CoV RT-PCR Kit

The CareGene N-CoV RT-PCR Kit is an in vitro diagnostic medical device for the qualitative detection of COVID-19 from RNA extracted from human Nasopharyngeal swab, Oropharyngeal swab and sputum using Real Time-PCR. It targets two regions of viral RNA (N gene and RdRP gene), with both the reverse transcription (RT) and qPCR step conducted in the same reaction well and has a reaction time of less than 83 minutes.
More details

COVID-19 Antigen Test
CareStart COVID-19 Antigen Test

The CareStart COVID-19 Antigen Test is an intended point-of-care (POC) designated test with a 10 minute processing time that allows effective screening of COVID-19 infection on a large scale. The lateral flow assay provides rapid results in 10 minutes using minimally invasive specimen collection (nasopharyngeal) and is intended for use at POC settings (i.e., in patient care settings) by medical professionals.
More details

COVID-19 RT-PCR Test
CareStart COVID-19 MDx RT-PCR

The CareStart COVID-19 MDx RT-PCR is intended for qualitative detection of SARS-CoV-2 RNA in upper respiratory specimens (such as and nasopharyngeal wash/aspirate or nasal aspirate) and bronchoalveolar lavage from individuals suspected of COVID-19 by their healthcare provider. The FDA emergency use authorized test has a processing time of less than 83 minutes and is available for use with the CFX96 system (Bio-Rad Laboratories, Inc.) and Applied Biosystems 7500/7500 Fast Real-Time PCR System (Thermofisher Scientific).
More details

COVID 19 IgM/IgG Test
CareStart COVID-19 IgM/IgG

The CareStart COVID-19 IgM/IgG Rapid Diagnostic Test for the Detection of SARS-CoV-2 IgM/IgG Ab provides a fast and easy diagnostic tool for COVID-19 in the limited testing environment. It detects and differentiates IgM/IgG antibody specific to SARS-CoV-2 using a small sample volume of 10 uL of venous whole blood, serum, or plasma) with results available in 10 minutes.
More details

Scrub Typhus IgM Test
CareStart Scrub Typhus IgM

The CareStart Scrub Typhus IgM is a rapid diagnostic test intended for the qualitative detection of immunoglobulin M (IgM) to O.tsutsugamushi in serum, plasma, or whole blood. The test is user-friendly, fast and reliable, and has a result time of 10-15 minutes.
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G6PD Test
CareStart G6PD RDT

The CareStart G6PD RDT is a qualitative point-of-care visual screening test that identifies G6PD deficient patients using whole blood sample. It uses the visual dye colorization assay method and has a result time of 10 minutes.
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Malaria Rapid Test
CareStart Malaria

The CareStart Malaria are qualitative rapid diagnostic tests that diagnose malaria infection from the whole blood of patients in 20 minutes. A lineup of 11 malaria RDT products is available for different combinations of Plasmodium parasites that cause malaria in humans, namely P. falciparum, P. vivax, P. malariae, P. ovale, as well as HRP2 deleted P. falciparum mutant malaria.
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Molecular Diagnostic Test
CareStart CAH

The CareStart CAH is a molecular diagnostic test for the screening for congenital adrenal hyperplasia (CAH) mutations on CYP21, using allele-specific primer extension (ASPE) and bead-array hybridization. It allows for the screening for CAH mutations on CYP21, using allele-specific primer extension (ASPE) and bead-array hybridization.
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HPV Diagnostic Test
CareStart HPV

The CareStart HPV diagnostic tests come in two different types of testing: genotyping and screening. The genotyping kit accurately identifies the type of virus infection through the DNA sequence analysis, while the screening kit primarily identifies the infections of high risk HPV infection, low-risk HPV, or non-infection.
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Dengue Rapid Test
CareStart Dengue Combo

The CareStart Dengue Combo (NS1 Ag+IgM/IgG) is a rapid diagnostic test that can simultaneously detect dengue virus using both dengue NS1 antigen and anti-dengue antibodies (IgM/IgG) with one device. It can detect all four dengue serotypes from serum, plasma, or whole blood and can diagnose dengue infection from the acute to the convalescent stage.
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G6PD Quantitative Test
careSTART G6PD Biosensor

The CareStart G6PD Biosensor is a quantitative point-of-care test for the quantitative measurement of total G6PD enzyme activity in whole blood specimen. It delivers results in just four minutes and is suitable for neonatal and adult screening purposes.
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Point-Of-Care Testing

COVID-19 IgM/IgG Assay
CareStart COVID-19 IgM/IgG

The CareStart COVID-19 IgM/IgG is an immunochromatographic lateral flow assay intended for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in human serum, plasma (sodium citrate, sodium heparin, or dipotassium EDTA), venous whole blood (sodium citrate, sodium heparin, or dipotassium EDTA) and fingerstick whole blood.
More details

HIV 1/2 Rapid Diagnostic Test
CareStart EZ HIV 1/2

The CareStart EZ HIV 1/2 is an in vitro RDT for the qualitative detection of antibodies to HIV type-1 and/or type-2 in serum, plasma, capillary whole blood or venous whole blood. The device is a single-use intended for healthcare professional use as an aid to diagnosis only – not for screening blood donors.
More details
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