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DBU - Healthcare

SAASKIN’s Distribution Business Unit (DBU) can provide a professional distribution platform to market your products in India. Currently we are the key distribution partner for range of OEM branded Healthcare and Life Sciences Technology products.

SD Biosensor Standard Q Covid-19 Antigen Test Kit
  • SD Biosensor Standard Q Covid-19 Antigen Test Kit
  • SD Biosensor Standard Q Covid-19 Antigen Test Kit
  • SD Biosensor Standard Q Covid-19 Antigen Test Kit
  • SD Biosensor Standard Q Covid-19 Antigen Test Kit
  • SD Biosensor Standard Q Covid-19 Antigen Test Kit

SD Biosensor Standard Q Covid-19 Antigen Test Kit

Product Price: Rs 350 / UnitGet Best Price

Product Brochure

Product Details:
Number of Reactions(Preps) per Kit1
BrandSD Biosensor
ICMR(Govt) ApprovedYes
Test MethodAntigen Test
Result Time (Rapid Kits)15-30 min
Sample TypeNasal Swab
Packaging Size25 Test Kits/Box
Country of OriginMade in India
Packaging TypeBox

STANDARD Q COVID-19 Antigen Test kit is chromatographic immunoassay for the qualitative detection of SARS???CoV???2 nucleocapsid antigen present in human nasal sample.

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InstaXport Covid 19 Viral Transport Medium Kit
  • InstaXport Covid 19 Viral Transport Medium Kit
  • InstaXport Covid 19 Viral Transport Medium Kit
  • InstaXport Covid 19 Viral Transport Medium Kit
  • InstaXport Covid 19 Viral Transport Medium Kit
  • InstaXport Covid 19 Viral Transport Medium Kit

InstaXport Covid 19 Viral Transport Medium Kit

Product Price: Rs 28 / KitGet Best Price

Minimum Order Quantity: 1000 Kit

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Product Details:
Kit ContentsViral Tranport Medium
BrandStrumed
Number of pieces per pack100
pH7.2 +/-0.2
Storage Temperature2-28
Shelf Life1 year
Usage/ApplicationVTM
Country of OriginMade in India
Viral Tranport Medium (VTM) Kit:
50 Test Tubes
100 Swabs (Oral & Nasal)

Additional Information:

  • Item Code: SCVTM01
  • Production Capacity: 1000000
  • Delivery Time: 1 week
  • Packaging Details: 50 Kits in Pack
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Abbott Panbio COVID Antigen Self Test
  • Abbott Panbio COVID Antigen Self Test
  • Abbott Panbio COVID Antigen Self Test
  • Abbott Panbio COVID Antigen Self Test
  • Abbott Panbio COVID Antigen Self Test

Abbott Panbio COVID Antigen Self Test

Price on Request

Product Details:
Number of Reactions(Preps)/Kit1
BrandAbbott
ICMR ApprovedYes
Test MethodAntigen Test
Result Time (Rapid Kits)10-15 mins
Sample TypeNasal Swab
Sensitivity95.2%
Specificity100%
  • The Panbio COVID-19 Antigen Self-Test is a single-use, in vitro (outside the body) visually read rapid immunoassay that uses a human nasal swab specimen for the qualitative detection of nucleocapsid protein SARS-CoV-2 antigen.
  • The test can determine if you have an active COVID-19 infection and you will know your test results in just 15 minutes
  • Only Proven High-Accuracy Self-Test in India
  • In clinical evaluations with self-test users, the Panbio COVID-19 Antigen Self-Test correctly identified 100% of negative samples and 95.2% of Positive Samples
  • Pregnancy had no impact on the performance of the test.
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Genbody Covid-19 Rapid Antigen Test Kit
  • Genbody Covid-19 Rapid Antigen Test Kit
  • Genbody Covid-19 Rapid Antigen Test Kit

Genbody Covid-19 Rapid Antigen Test Kit

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Product Details:
Number of Reactions(Preps) per Kit1
BrandGenbody
ICMR(Govt) ApprovedYes
Test MethodAntigen Test
Result Time (Rapid Kits)15 min
Sample TypeNasal Swab
Packaging Size25 Test Kits /Box
Packaging TypeBox
GenBody COVID-19 Ag is an immunochromatographic assay kit for the qualitative detection of SARS-CoV-2 antigen in nasopharyngeal and oropharyngeal swab from human.
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Standard M N CoV SD Biosensor RT Detection Kit
  • Standard M N CoV SD Biosensor RT Detection Kit
  • Standard M N CoV SD Biosensor RT Detection Kit

Standard M N CoV SD Biosensor RT Detection Kit

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Product Details:
Number of Reactions(Preps) per Kit96
BrandSD Biosensor
ICMR(Govt) ApprovedYes
Test Method(SARS-CoV-2) RT-PCR
Result Time (Rapid Kits)90 min
Sample TypeNasal Swab
Usage/ApplicationCorona
Storage Temperature-25 To -15 Degree Celsius
Packaging Type96 Tests/Kit
Packaging TypeBox
STANDARD M nCoV Real-Time Detection kit is used for identification and detectionof novel coronavirus (2019-nCoV) ORF1ab (RdRp) gene and E gene in humannasopharyngeal swab, oropharyngeal swab, and sputum specimens using reversetranscription (RT) real-time PCR. This kit is helpful for the auxiliary diagnosis of 2019novel coronavirus disease (COVID-19). The test results are for clinical referenceonly and cannot be used as a basis for confirming or excluding cases alone.
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Sure Status Covid-19 Antigen Card Test Kit
  • Sure Status Covid-19 Antigen Card Test Kit
  • Sure Status Covid-19 Antigen Card Test Kit
  • Sure Status Covid-19 Antigen Card Test Kit
  • Sure Status Covid-19 Antigen Card Test Kit
  • Sure Status Covid-19 Antigen Card Test Kit
  • Sure Status Covid-19 Antigen Card Test Kit
  • Sure Status Covid-19 Antigen Card Test Kit
  • Sure Status Covid-19 Antigen Card Test Kit
  • Sure Status Covid-19 Antigen Card Test Kit

Sure Status Covid-19 Antigen Card Test Kit

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Product Details:
Number of Reactions(Preps) per Kit1
BrandSure Status
ICMR(Govt) ApprovedYes
Test MethodAntigen Test
Result Time (Rapid Kits)15 min
Sample TypeNasal Swab
Packaging Size25 Test Kits/Box
Shelf Life24 Months
Storage Temperature4-30 Degree Celsius
Country of OriginMade in India
Packaging TypeBox
Sure Status COVID-19 Antigen Card Test is a rapid chromatographic immunoassay for the qualitative detection of specific antigens to SARS-CoV-2 present in human nasopharynx.
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Cellex Covid Antibody Test Kit

Cellex Covid Antibody Test Kit

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Product Brochure

Product Details:
Number of Reactions(Preps)/Kit25
BrandCellex
Test Method(SARS-CoV-2) IgM/IgG Rapid Antibody
Result Time (Rapid Kits)30 minutes
Sample TypeBlood
ICMR(Govt) ApprovedNo
Time To Result15 mins
Packaging Size25 Tests /pack
COVID-19 serology test.Cellex qSARS-CoV-2 IgG/IgM Rapid Test.qSARS-CoV-2 IgG/IgM Rapid Test Cassette.FDA Grants Emergency Authorization for First Rapid Antibody Test for COVID-19
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Patho Detect COVID-19 Qualitative RT PCR Test Kit
  • Patho Detect COVID-19 Qualitative RT PCR Test Kit
  • Patho Detect COVID-19 Qualitative RT PCR Test Kit
  • Patho Detect COVID-19 Qualitative RT PCR Test Kit

Patho Detect COVID-19 Qualitative RT PCR Test Kit

Price on Request

Product Brochure

Product Details:
Number of Reactions(Preps) per Kit100
BrandMylab
ICMR(Govt) ApprovedYes
Test Method(SARS-CoV-2) RT-PCR
Result Time (Rapid Kits)3 Hours
Sample TypeNasal Swab
MethodPCR

 

Pathodetect 2019- nCov Detectioin kit offer an in virto diagnostic real time PCR assay for qualitative detection of 2019 - Novel Coronavirus RNA in respiratory specimens and sera. The kit offer the universal detection of SARS- Like coronavirus and specific detection of 2019-nCOv.

Mylab Discovery solutions 2019-nCoV Detection Kit provides ready to use solution for detection of coronavirus using real time PCR technology. Detection is based on the amplification of a specific conserved RNA sequences of coronavirus and detection by Taqman probe-based chemistry. An Internal control is detected along with the coronavirus target controlling the extraction efficacy and possible PCR inhibition. The test is designed to use across wide range of PCR platforms. The recommended CDC protocol for coronavirus detection ensures that the kit leads to highly-specific and ultrasensitive results in short time. 

KIT CONTENTS

  • Reagents for Nucleic acid extraction from respiratory/sera specimens
  • Reagents for Real time PCR
  • Inclusion of synthetic positive and negative controls

 

KIT FEATURES:

  • Design of the kit as per CDC/WHO recommended protocol
  • Highly Sensitive real time PCR test for novel coronavirus 2019 detection
  • Includes all reagent required to perform Sample to Result analysis no additional reagents needed.
  • Synthetic Positive controls provided for validity of the test
  • Inclusion of internal control for quality check throughout the procedure
  • Low contamination risk  no post-PCR product handling
  • High-throughput  can screen up to 24 samples in a single run
  • Fast  sample to results within two hours

 



Additional Information:

  • Production Capacity: 100000
  • Delivery Time: 1 week
  • Packaging Details: Carton Box of 100 piece each
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ID Now Covid-19 RT PCR Machine
  • ID Now Covid-19 RT PCR Machine
  • ID Now Covid-19 RT PCR Machine
  • ID Now Covid-19 RT PCR Machine
  • ID Now Covid-19 RT PCR Machine
  • ID Now Covid-19 RT PCR Machine
  • ID Now Covid-19 RT PCR Machine
  • ID Now Covid-19 RT PCR Machine
  • ID Now Covid-19 RT PCR Machine
  • ID Now Covid-19 RT PCR Machine
  • ID Now Covid-19 RT PCR Machine
  • ID Now Covid-19 RT PCR Machine
  • ID Now Covid-19 RT PCR Machine

ID Now Covid-19 RT PCR Machine

Price on Request

Product Brochure

Product Details:
BrandAbbott
Model Name/NumberID Now
Sample Capacity/FormatCartridge
Volume Thermal Block Sample0.5 mL
Communication InterfaceBluetooth, USB
Scan time13 minutes
UsageMolecular COVID-19 Test
Direct Sample TypeThroat Swab/Nasal Swab
Storage TemperatureRoom Temperature
ID NOW COVID-19SARS-COV-2 IN 13 MINUTES OR LESS*

The ID NOW platform combines the benefits of speed and accuracy for the fastest molecular results in the market.

The ID NOW COVID-19 test returns positive results in 13 minutes or less to enable immediate clinical decisions during the first patient visit.

The easy to use ID NOW platform is designed for near-patient, point-of-care use in a variety of healthcare settings.

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Immuno Quick Covid-19 IGM IGG Rapid Antibody Corona Test Kit
  • Immuno Quick Covid-19 IGM IGG Rapid Antibody Corona Test Kit
  • Immuno Quick Covid-19 IGM IGG Rapid Antibody Corona Test Kit
  • Immuno Quick Covid-19 IGM IGG Rapid Antibody Corona Test Kit
  • Immuno Quick Covid-19 IGM IGG Rapid Antibody Corona Test Kit
  • Immuno Quick Covid-19 IGM IGG Rapid Antibody Corona Test Kit
  • Immuno Quick Covid-19 IGM IGG Rapid Antibody Corona Test Kit
  • Immuno Quick Covid-19 IGM IGG Rapid Antibody Corona Test Kit
  • Immuno Quick Covid-19 IGM IGG Rapid Antibody Corona Test Kit

Immuno Quick Covid-19 IGM IGG Rapid Antibody Corona Test Kit

Price on Request

Product Brochure

Product Details:
Number of Reactions(Preps)/Kit25
BrandImmuno Quick
ICMR(Govt) ApprovedYes
Test Method(SARS-CoV-2) IgM/IgG Rapid Antibody
Result Time (Rapid Kits)10 Minutes
Sample TypeBlood
TypeRapid Test Kit
Storage Temperature3-30 Degree C
Country of OriginMade in India

ImmunoQuick Covid-19 IgM/IgG Test : 

Covid-19 or commonly known as Coronavirus is a viral infection involving a patients upper respiratory tract. It is highly contagious and causes a severe lung infection which can be severely debilitating and sometimes fatal. Our test detects two types of antibodies to Covid-19 which appear from 2 to 21 days after infection. It is an invaluable test to diagnose people who have been sick for a few days or those who have recovered.

 

Salient Features of the Product

It is rapid immunoassay for qualitative detection of Covid-19 IgM and IgG antibodiesin

Human Serum or Plasma or Whole Blood.

Results available in 15 minutes.

Sensitivity :: >96%

Specificity :: >99%

No cross reactivity observed.

Can be stored at 4 to 30C

Stable for 24 months.

Pack size :: 25 tests.

 



Additional Information:

  • Production Capacity: 500000
  • Delivery Time: 1 Day
  • Packaging Details: Carton Box
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AbChek COVID-19  Antibody Rapid Test Kit
  • AbChek COVID-19  Antibody Rapid Test Kit
  • AbChek COVID-19  Antibody Rapid Test Kit
  • AbChek COVID-19  Antibody Rapid Test Kit
  • AbChek COVID-19  Antibody Rapid Test Kit
  • AbChek COVID-19  Antibody Rapid Test Kit
  • AbChek COVID-19  Antibody Rapid Test Kit
  • AbChek COVID-19  Antibody Rapid Test Kit
  • AbChek COVID-19  Antibody Rapid Test Kit

AbChek COVID-19 Antibody Rapid Test Kit

Price on Request

Product Brochure

Product Details:
Number of Reactions(Preps)/Kit50
BrandAbChek
ICMR(Govt) ApprovedYes
Test Method(SARS-CoV-2) IgM/IgG Rapid Antibody
Result Time (Rapid Kits)5-10 minutes
Sample TypeBlood
TypeRapid Test Kit
Sensitivity98
Packaging Size50 Tests/ Box
Country of OriginMade in India

Corona viruses are enveloped RNA viruses that are distributed broadly among humans, birds and other mammals, that cause respiratory, enteric, hepatic, and neurologic disease.

SPECIFICATIONS:

Whole blood/serum/plasma may be used for testing.

Results available in only 15 minutes.

Easy to use.

Result can be read visually.

No need for an analyser.

Cost effective method for assisting in screening COVID-19 disease.



Additional Information:

  • Item Code: RapidTestcov19
  • Production Capacity: 100000
  • Delivery Time: 10 days
  • Packaging Details: Carton Box
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Abbott Panbio COVID-19 Rapid Antigen Test Kit
  • Abbott Panbio COVID-19 Rapid Antigen Test Kit
  • Abbott Panbio COVID-19 Rapid Antigen Test Kit
  • Abbott Panbio COVID-19 Rapid Antigen Test Kit
  • Abbott Panbio COVID-19 Rapid Antigen Test Kit
  • Abbott Panbio COVID-19 Rapid Antigen Test Kit
  • Abbott Panbio COVID-19 Rapid Antigen Test Kit
  • Abbott Panbio COVID-19 Rapid Antigen Test Kit
  • Abbott Panbio COVID-19 Rapid Antigen Test Kit
  • Abbott Panbio COVID-19 Rapid Antigen Test Kit

Abbott Panbio COVID-19 Rapid Antigen Test Kit

Price on Request

Product Brochure

Product Details:
Number of Reactions(Preps) per Kit1
BrandAbbott Panbio
ICMR ApprovedYes
Test MethodAntigen Test
Result Time (Rapid Kits)15 min
Sample TypeNasal Swab
Packaging Size25 Test Kits/Box
Country of OriginMade in India
Packaging TypeBox
Panbio™ COVID-19 Ag Rapid Test Device is an in vitro diagnostic rapidtest for the qualitative detection of SARS-CoV-2 antigen (Ag) in humannasopharyngeal swab specimens from individuals who meet COVID-19clinical and / or epidemiological criteria. Panbio™ COVID-19 Ag RapidTest Device is for professional use only and is intended to be used asan aid in the diagnosis of SARS-CoV-2 infection.
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Seegene Covid 19 RT PCR Test Kit
  • Seegene Covid 19 RT PCR Test Kit
  • Seegene Covid 19 RT PCR Test Kit

Seegene Covid 19 RT PCR Test Kit

Price on Request

Product Brochure

Product Details:
Number of Reactions(Preps) per Kit100
BrandSeegene
ICMR(Govt) ApprovedYes
Test Method(SARS-CoV-2) RT-PCR
Sample TypeNasal & Oral Swab
Test Time2 Hours
DiseaseCorona
-Detection of COVID-19 specic target genes in a single tube- Reliable result with three target genes- Results within 1 hour and 50 minutes after extraction- Convenient workow on the automated MDx platform- Suitable for high-throughput- Providing whole process control for assay validity- Automated data interpretation with Seegene Viewer

Additional Information:

  • Production Capacity: 500000
  • Delivery Time: Immediate
  • Packaging Details: Box Carton Box Wooden Crate
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Strumed Instaxplor Covid-19 Rapid Antigen Test Kit
  • Strumed Instaxplor Covid-19 Rapid Antigen Test Kit
  • Strumed Instaxplor Covid-19 Rapid Antigen Test Kit
  • Strumed Instaxplor Covid-19 Rapid Antigen Test Kit
  • Strumed Instaxplor Covid-19 Rapid Antigen Test Kit
  • Strumed Instaxplor Covid-19 Rapid Antigen Test Kit

Strumed Instaxplor Covid-19 Rapid Antigen Test Kit

Price on Request

Product Brochure

Product Details:
Number of Reactions(Preps)/Kit25
BrandStrumed
ICMR ApprovedYes
Test MethodAntigen Test
Result Time (Rapid Kits)10-15 mins
Sample TypeNasal Swab
Sensitivity98
Specificity100
Shelf Life24 Months
Storage Temperature2-30 degree C
Country of OriginMade in India
ICMR & CDSCO Approved, CE marked COVID 19 rapid antigen test for the detection of corona virus.

Additional Information:

  • Item Code: STRUCOVAG001
  • Production Capacity: 200000/day
  • Delivery Time: 15 DAYS
  • Packaging Details: 25 tests in a pack, 40 Packs in one master carton
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Access Bio Care Start Covid-19 Rapid Antigen Test Kit
  • Access Bio Care Start Covid-19 Rapid Antigen Test Kit
  • Access Bio Care Start Covid-19 Rapid Antigen Test Kit
  • Access Bio Care Start Covid-19 Rapid Antigen Test Kit
  • Access Bio Care Start Covid-19 Rapid Antigen Test Kit
  • Access Bio Care Start Covid-19 Rapid Antigen Test Kit
  • Access Bio Care Start Covid-19 Rapid Antigen Test Kit

Access Bio Care Start Covid-19 Rapid Antigen Test Kit

Price on Request

Product Brochure

Product Details:
Number of Reactions(Preps) per Kit1
BrandAccess Bio
Test MethodAntigen Test
Result Time (Rapid Kits)10 min
Sample TypeNasal Swab
Packaging Size20 Test Kits/Box
Packaging TypeBox
The CareStart™ COVID-19 Antigen test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals who are either suspected of COVID-19 by their healthcare provider within first five days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.

Additional Information:

  • Item Code: SCABAT01
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Abbott Covid-19 Rapid Antigen Card Test Kit
  • Abbott Covid-19 Rapid Antigen Card Test Kit
  • Abbott Covid-19 Rapid Antigen Card Test Kit
  • Abbott Covid-19 Rapid Antigen Card Test Kit

Abbott Covid-19 Rapid Antigen Card Test Kit

Price on Request

Product Brochure

Product Details:
Number of Reactions(Preps)/Kit1
BrandAbbott
ICMR ApprovedYes
Test MethodAntigen Test
Result Time (Rapid Kits)10-15 min
Sample TypeNasal Swab
Packaging Size25 Test Kits/Box
Packaging TypeBox
TheBinaxNOWTM COVID-19 Ag Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.
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Molbio Truenat COVID 19 Chip based Real Time PCR Test Kit
  • Molbio Truenat COVID 19 Chip based Real Time PCR Test Kit
  • Molbio Truenat COVID 19 Chip based Real Time PCR Test Kit
  • Molbio Truenat COVID 19 Chip based Real Time PCR Test Kit
  • Molbio Truenat COVID 19 Chip based Real Time PCR Test Kit
  • Molbio Truenat COVID 19 Chip based Real Time PCR Test Kit
  • Molbio Truenat COVID 19 Chip based Real Time PCR Test Kit

Molbio Truenat COVID 19 Chip based Real Time PCR Test Kit

Price on Request

Product Details:
BrandMolbio
Sample TypeNasal Swab
Storage Temperature2-40 degree celsius
Country of OriginMade in India
Extraction duration20mins
Pack size50T
Truenat™ COVID-19 Chip-based Real Time PCR Test is a semi quantitative detection of SARS CoV-2 RNA in human oropharyngeal and nasopharyngeal swab specimen and aids in detection and confirmation of SARS CoV-2 infection and diagnosis of COVID-19. The test detects the E and Orf1a genes of the virus.

Providing you the best range of Molbio Trueprep Auto Universal Cartridge Based Sample Prep Device, Molbio Trueprep AUTO Universal Cartridge Based Sample Prep Kit, Molbio Trueprep AUTO MTB Sample Pre Treatment Pack Kit, Molbio Trueprep AUTO Universal Sample Pre-treatment Pack and Molbio Trueprep AUTO Transport Medium for Swab Specimen Pack with effective & timely delivery.
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ThermoFisher Scientific Accula System Rapid & Reliable RT-PCR Test for Corona in 30mins
  • ThermoFisher Scientific Accula System Rapid & Reliable RT-PCR Test for Corona in 30mins
  • ThermoFisher Scientific Accula System Rapid & Reliable RT-PCR Test for Corona in 30mins

ThermoFisher Scientific Accula System Rapid & Reliable RT-PCR Test for Corona in 30mins

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Product Brochure

Product Details:
Number of Reactions(Preps)/Kit25
BrandThermo
Test Method(SARS-CoV-2) RT-PCR
Sample TypeNasal Swab
Test Time30 min
The Accula™ System from Thermo Fisher Scientific is a rapid diagnostic platform that combines the accuracy of RT-PCR with the simplicity, convenience, and procedural familiarity of traditional rapid immunoassays. The Accula™ SARS-CoV-2 Test has received an Emergency Use Authorization (EUA) from the FDA for the detection of SARS-CoV-2 in Clinical Laboratory Improvement Amendments (CLIA)–waived environments. Designed for use with the palm-sized Accula™ Dock, the Accula SARS-CoV-2 Test provides reliable, qualitative results in approximately 30 minutes
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Thermo Scientific OmniPATH COVID-19 Total Antibody ELISA Test

Thermo Scientific OmniPATH COVID-19 Total Antibody ELISA Test

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In a single test, the Thermo ScientificTM OmniPATHTM COVID-19 Total Antibody ELISA Test provides a comprehensivelook at the adaptive antibody immune response to SARS-CoV-2, the virus that causes COVID-19, by detectingantibodies to the receptor binding domain (RBD) of the S1 subunit of the spike (S) protein.

Why the spike (S) protein RBD?
The spike protein is a major antigen target of vaccines.Antibodies that detect the RBD are more likely tobe neutralizing. Compared to other SARS-CoV-2 proteins,the RBD has less similarity to other coronaviruses,which can provide diagnostic specificity advantages.

Why a total antibody test?
Combined detection of IgG with other isotypes mayimprove serology sensitivity early in courseof COVID-19. Total antibody testing can detect both long-term (IgG)and more transient (IgA, IgM) antibody isotypes, thusproviding an overall picture of SARS-CoV-2 antibodyresponse, whether the infection happened more recently,or several months ago.
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Thermo Fisher Taqpath Covid-19 Combo Kit

Thermo Fisher Taqpath Covid-19 Combo Kit

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The Applied Biosystems TaqPath COVID-19 Combo Kit is a fast, highly sensitive multiplex diagnostic solution that contains the assays and controls needed for the real-time PCR detection of RNA from the SARS-CoV-2 virus.

Features of the newly developed multiplex diagnostic kit:
• A complete workflow from viral RNA extraction from up to 94 specimens and genetic analysis using real-time PCR to diagnostic report generation in under 4 hours
• Targeted specificity to 100% of currently available complete genomes for SARS-CoV-2
• Assay targets spike (S) protein and nucleocapsid (N) protein regions having higher specificity and exhibiting lower risk for mutation
• COVID-19 Interpretive Software, which automatically converts genetic analysis data into diagnosis, helping reduce risk of user interpretation error

The TaqPath COVID-19 Combo Kit consists of both the TaqPath RT-PCR COVID-19 Kit and the TaqPath COVID-19 Control Kit for simplified ordering. The kit can be used by clinical and public health laboratories to quickly evaluate up to 94 patient specimens in under 3 hours. The kit is approved for use with RNA extracted from nasopharyngeal swabs, nasopharyngeal aspirate (nasal aspirate), and bronchoalveolar lavage (BAL) from patients at risk of exposure to the SARS-CoV-2 virus or with signs and symptoms of COVID-19 (see product label for Intended Use Statement and product information). The TaqPath COVID-19 Combo Kit is a single, high-throughput (1,000 reactions) kit and is recommended for use with either the Applied Biosystems 7500 Fast Dx Real-Time PCR System or the 7500 Fast Real-Time PCR System (RUO version) and the associated Applied Biosystems COVID-19 Interpretive Software.

The TaqPath COVID-19 Combo Kit includes the following components:
• TaqPath RT-PCR COVID-19 Kit
    --COVID-19 real-time PCR assay multiplex—multiplexed assays that contain three primer/probe sets specific to different SARS-CoV-2 genomic regions and primers/probes for bacteriophage MS2
    --MS2 phage control—internal process control for nucleic acid extraction
• TaqPath COVID-19 Control—RNA control that contains targets specific to the SARS-CoV-2 genomic regions targeted by the assays
• TaqPath COVID-19 Control Dilution Buffer—dilution buffer for the IVT RNA control as defined in the IFU (information for use)

Intended use
The TaqPath COVID-19 Combo Kit contains the assays and controls for a real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, nasopharyngeal aspirate, and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider. The TaqPath COVID-19 Combo Kit is for use only under Emergency Use Authorization (EUA). Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in nasopharyngeal swab, nasopharyngeal aspirate, and bronchoalveolar lavage (BAL) specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
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Applied Biosystems TaqPath 1 Step Multiplex Master Mix Real Time PCR Kit

Applied Biosystems TaqPath 1 Step Multiplex Master Mix Real Time PCR Kit

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TaqPath 1-Step Multiplex Master Mix (No ROX) is a fast, single-tube, 4X RT-qPCR mix that provides for sensitive, reproducible detection of up to four different RNA/DNA targets in a single multiplex reaction. Particularly useful for diagnostics, virus detection, and high throughput gene expression workflows, the mix includes thermostable MMLV reverse transcriptase, dNTPs, UNG, and thermostable Fast DNA polymerase all in a single tube. TaqPath is manufactured under a strong ISO13485 quality management system and is designed to produce consistent product performance lot after lot.

This single-tube, 4X format facilitates easy reaction set up—just add user-supplied assay and sample (Figure 1). With reproducible performance even in the presence of inhibitors, coupled with stringent quality control to minimize lot-to-lot variation, TaqPath 1-Step Multiplex Master Mix (No ROX) is a superior choice for your multiplex diagnostic testing or development needs.

High sensitivity
To enable reproducible detection of low-titer pathogen and transcripts, TaqPath 1-Step Multiplex Master Mix (No ROX) has been optimized as a higher-concentration 4X master mix that allows you to input more sample into each reaction, increasing sensitivity even in low-volume reactions. Figure 1 shows the consistency of results obtained when detecting 10 copy inputs of RNA target.

Wide dynamic range compatible with RNA and DNA
TaqPath 1-Step Multiplex Master Mix (No ROX) has been optimized to provide high specificity and dynamic range for use with both RNA and DNA targets. Since virology labs often test for both RNA and DNA viruses, TaqPath 1-Step Multiplex Master Mix (No ROX) is designed to use a single protocol to assay both types of nucleic acid. This input flexibility can help streamline the number of different workflows in your lab to improve efficiency. Figure 2 demonstrates the excellent PCR linearity across a 6-log RNA dilution series, while Figure 3 exhibits a 6-log linear dynamic range for both RNA and DNA targets.
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