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NeoDx Help Center

  • What are the gene targets detected by the 4R assay kit?
    CoviDx mPlex-4R SARS-CoV-2 RT-PCR is a multiplex assay kit where the detection of four genes (3 SARS-CoV-2 and 1 human internal control) can be detected in a single tube reaction. CoviDx mPlex-4R SARS-CoV-2 primer and probe sets are designed for the detection of E-gene, N-gene, and RdRP-gene of SARS-CoV-2 along with human internal control RNase P in a single tube assay, based on Berlin protocol.
  • Is positive control provided in the 4R kit?
    Yes, a positive test control of 100μL volume is included in our kit.
  • What Ct cutoff values should be used when interpreting the assay data?
    The Ct cutoff value designed for our kit is 37. If Ct ≤ 37 for all the genes, then the sample is considered positive while a Ct ≥ 37 is considered to be negative.
  • How fast can I obtain the results using mPlex 4R?
    4R has two different thermal cycle conditions. The standard time is 90 minutes which will run on all RT-PCR instruments with four and above detection channels. The fastest thermal cycle condition is 30 minutes which is compatible with the following RT-PCR instruments: BioRad CFX 96, BioRad Opus, Quantstudio5.
  • Which detection chemistry is used in the 4R kit?
    4R kit uses one-step RT-qPCR with a hydrolysis probe chemistry that uses 5’ nuclease activity of Taq DNA polymerase and enables detection of PCR amplified products by fluorescence.
  • How to troubleshoot if abnormal curves and ΔRn values are being obtained?
    It is important to remember that some samples might have lower Ct values than the baseline, hence abnormal plots will be observed if the baselines are not set properly. When this happens, switch from manual to automatic baseline, or move the baseline to a lower Ct (2 cycles before the amplification curve for the sample crosses the threshold).
  • What are the specifications of your CoviDx™ Assure SARS-CoV-2 RT-PCR Detection kit?
    CoviDx Assure SARS-CoV-2 RT-PCR is a multiplex assay kit for detection of 2 genes in a single tube reaction. Targeted Genes are (2+1): E Gene N Gene RnaseP (Human Internal Control) This kit uses one-step RT-qPCR with a hydrolysis probe chemistry that uses 5’ nuclease activity of Taq DNA polymerase and enables detection of PCR product which gets amplified at every step during PCR cycles by producing fluorescence.
  • What instruments, consumables, and reagents are required for running your RT-PCR assay?
    All the reagents required for the detection are included in our kits. To run RT PCR with our kits, you must have pipettes, vortex machines, PCR tubes and RT-PCR instruments connected to a software to read the results.
  • What is the turnaround time for 2 Gene kits?
    The standard time is around 1 hr, while the faster method gives the results within 30 minutes.
  • How can I interpret the results?
    A specimen is considered positive for COVID-19 in case of reaction growth curves that cross the threshold line within < 37 cycles for E gene and N gene targets. Negative test controls should be negative and should not exhibit fluorescence amplified curves that cross the threshold line, while the positive test controls should produce a positive result within 37 cycles.
  • What are the authorizations or regulatory approvals applicable for CoviDx Assure SARS-CoV-2 RT-PCR Kit?
    CoviDx Assure SARS-CoV-2 RT-PCR Kit has received IVD status from the Indian FDA (CDSCO) and is also approved by the apex body in India for the formulation, coordination and promotion of biomedical research, Indian Council of Medical Research (ICMR), which is one of the oldest and largest medical research bodies
  • How do I interpret the control results?
    Positive control should produce a positive result with an expected Ct value for each target included in the test i.e., cross the threshold line within < 37 cycles for E gene, N gene and RdRP target. The negative test controls should be negative and should not exhibit fluorescence amplified curves that cross the threshold line.
  • What if amplification signals are observed in the early cycles of amplification?
    If amplification signals are detected in the early cycles of RT-PCR, you must dilute your sample further to increase the Ct value.
  • Which RT-PCR equipment is compatible with your kit?
    Our kit is compatible with all the RT PCR instruments having four or more detection channels, for which the standard timing is 90 minutes. The fast protocol is applicable to the following RT-PCR instrument which will give results in 30 minutes. : BioRad CFX96 BioRad opus Quantstudio 5 RotorGene Want to know if your RT-PCR System is compatible with our Real-time PCR Kits? Write to us at
  • Does your test include an internal control, and if so, what is it?
    Yes, the test kit comes with an internal control which is a Human RNase P gene.
  • What can be interpreted, if the E gene is positive and the other genes are negative for the sample?
    For the patient to be positive for SARS-CoV 2, all the genes must be positive. If the E gene is positive and the rest of the genes are negative, it indicates a presumptive positive i.e. the sample may be positive for other Sars Co Virus.
  • What makes DirectPlex different from the mPlex-4R detection kit?
    CoviDx™ DirectPlex is an in vitro extraction free, RT-PCR based qualitative assay for the detection of SARS-CoV-2 RNA in human respiratory specimens. 4R and directPlex detect the same set of genes but 4R requires RNA extraction.
  • At what temperature is the kit maintained during shipping?
    While shipping, the kits will be stored safely in a packaging box and the temperature conditions will be maintained between -15℃ to -25℃.
  • Is NeoDx Biotech Labs involved in any collaborations or partnerships?
    Yes, NeoDx Biotech Labs actively seeks collaborations and partnerships with healthcare organizations, research institutions, and other stakeholders. We believe in fostering collaborations to accelerate the development and deployment of innovative diagnostic solutions in the Indian healthcare ecosystem.
  • How do I get a Quote for a product?
    To get a Quote, kindly fill in this form - Our Sales team will reach out to you with relevant information.
  • I need technical support for NeoDx Products.
    Kindly send us the following details at Organization Name: Point of Contact: Email ID & Contact number: Product Name: Lot No: Query/Support needed: Our tech support team will reach out to you at the earliest to ensure a satisfactory resolution.
  • What are In-vitro Diagnostic assays?
    In-vitro Diagnostic assays are laboratory tests performed on samples taken from the body, such as blood or urine. These tests are used to diagnose diseases, monitor treatment progress, and screen for various health conditions.
  • How can Diagnostic Labs, Healthcare providers, or researchers access NeoDx Biotech Labs' assays?
    Diagnostic Labs, Healthcare providers, or researchers can reach out to NeoDx Biotech Labs through our website or contact us directly to inquire about our assays. We provide information on assay availability, ordering processes, and any required collaborations or partnerships.
  • Is Real-Time PCR Better than Lateral Flow Assay?
    Sensitivity: RT-PCR (Real-Time Polymerase Chain Reaction) tests are highly sensitive and can detect very small amounts of genetic material (RNA) from a virus. They are considered the gold standard for diagnosing viral infections, including COVID-19. Accuracy: RT-PCR tests have high accuracy and specificity, meaning they can accurately identify the presence of a specific virus and differentiate it from other similar viruses. Quantitative Analysis: RT-PCR tests provide quantitative results, indicating the viral load in the sample. This information can be helpful in assessing the severity of the infection and monitoring the progression of the disease. RT-PCR tests offer high sensitivity, accuracy, and quantitative analysis, lateral flow assays provide rapid results and simplicity. The choice between the two depends on factors such as the specific use case, testing objectives, available resources, and the need for sensitivity or speed.
  • Internship Opportunity With NeoDx.
    To apply for internship, kindly send us your updated resume along with cover letter to We'll reach out to you if there are any suitable opportunities.
  • Are NeoDx Biotech Labs' assays cost-effective?
    NeoDx Biotech Labs strives to develop assays that are not only accurate but also cost-effective. We understand the importance of affordable diagnostic solutions in the Indian & Global healthcare market. By leveraging advanced bioinformatics and optimizing assay development processes, we aim to offer cost-effective diagnostic solutions without compromising on quality.
  • How long does it take to perform a real-time PCR test for BCR-ABL using NeoDx's BCR-ABL Quantitative RT-PCR Detection kit?
    The total time required to perform a real-time PCR test for detection of the BCR-ABL gene using NeoDx's BCR-ABL Quantitative RT-PCR Detection kit is around 90 minutes from the start of the PCR Run.
  • What is the purpose of the BCR-ABL Quantitative RT-PCR Kit?
    The most frequent applications of a BCR-ABL test are for the diagnosis or exclusion of Ph-positive ALL, a particular kind of acute lymphoblastic leukaemia (ALL), and chronic myeloid leukaemia (CML). Ph-positive indicates the Philadelphia chromosome was present in Clinical Sample, a hallmark of Chronic Myeloid Leukemia. The BCR-ABL1 RT-PCR Kit offers sensitive and accurate detection and quantification of BCR-ABL1 p210 b2a2 or b3a2 transcripts, translation of data to the international scale, and MMR and MR 5 reporting.
  • Can NeoDx's BCR-ABL Quantitative RT-PCR Detection kit be used to detect mutation in the BCR-ABL gene in newborns?
    The BCR-ABL gene is not the type of mutation that is inherited from one’s parents. It is a type of somatic mutation, which means that one is not born with it, but can later acquire it in life. Therefore, a newborn is not likely to have this kind of gene mutation.
  • What are the benefits of using NeoDx’s BCR-ABL Quantitative RT-PCR Detection Kit?
    NeoDx’s BCR-ABL Quantitative RT-PCR Detection Kit is a Single-Tube, Multiplex Real-Time PCR Assay that offers sensitive and specific detection of Major (M-BCR) p210, Minor (m-BCR) p190, and Micro (μ-BCR) p230 BCR-ABL transcripts in CML patient samples along with ABL1 transcript (internal control) with RNA as a template. It consists of High-Quality Takara Mastermix which shows Increased Thermostability, Inhibitor Tolerance and Reproducibility. It is compatible with FAM, HEX/VIC, Texas Red/ROX, and Cy5 supporting PCR Instruments and has a turnaround time of 90 minutes. The kit works with RNA extracted from whole blood EDTA and bone marrow aspirates. It supports reverse transcription, so no additional cDNA synthesis is required in doing the procedure. The quantification standards offered have known copy numbers and are calibrated against the WHO First International Genetic Reference Panel for the Quantification of BCR-ABL1 Translocation (09/138), which enables the assignment of IS values to a measured level of BCR ABL/ABL%. The reporting is based on suggestions from the European Leukemia Net (ELN) and European Treatment and Outcome Study (EUTOS) guidelines.
  • Can NeoDx's BCR-ABL Quantitative RT-PCR Detection kit differentiate between different BCR-ABL strains or subtypes?
    The kit is designed to detect the amount of mutation the particular gene has undergone in the specifically mentioned regions of the genome, in turn detecting the three principal forms (P190, P210, and P230) in which the gene exists. However, the kit can’t differentiate between the different forms.
  • What are the benefits of using a real-time PCR kit for BCR-ABL?
    Polymerase chain reaction (PCR) is used by the BCR-ABL Real-time PCR Kit to identify BCR-ABL fusion gene transcripts. It includes chemicals and enzymes for the precise amplification necessary for the fast and accurate detection of the precise amplicon in fluorescence channels FAM. Additionally, it has a method that amplifies the human ABL gene under endogenous control to detect potential PCR inhibition and RNA purification. To aid the run, an external mutation-positive control is provided. For the identification of relatively rare targets, it also provides great reproducibility, accuracy, and enhanced sensitivity. For tracking the effectiveness of tyrosine kinase inhibitor therapy and quantitatively evaluating minimum residual illness, real-time quantitative RT-qPCR of BCR-ABL1 RNA is a crucial laboratory tool. BCR-ABL1 qRT-PCR measures the molecular response, which helps identify unsatisfactory responses and can help guide the choice to switch to different medications that could be more effective (or to seek more rigorous monitoring).
  • What sample types can be used with NeoDx's BCR-ABL Quantitative RT-PCR Detection kit?
    NeoDx's BCR-ABL Quantitative RT-PCR Detection kit makes use of the samples like whole blood EDTA and bone marrow aspirates.
  • Are real-time NeoDx’s PCR kits for BCR-ABL suitable for self-testing at home?
    NeoDx’s BCR-ABL Quantitative RT-PCR Detection kit is solely designed for use in laboratories and healthcare facilities. They are not designed to be used in homes without expertise.
  • How does the BCR-ABL Quantitative RT-PCR Kit work?
    The process takes place in a one-step RT-PCR technique. The initial step involves the transcription of the leukaemia BCR-ABL fusion gene (M-BCR m--BCR) into cDNA. After that, the relevant gene fragments are amplified using PCR (polymerase chain reaction) and a thermostable DNA polymerase.
  • Is NeoDx's BCR-ABL Quantitative RT-PCR Detection Kit approved for clinical use?
    The BCR-ABL Quantitative RT-PCR Detection Kit is helpful in diagnostic labs, hospitals, and clinical environments. To assure their accuracy, dependability, and conformance to regulatory standards, our kits have undergone extensive testing and validation.
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