B19-Q Real-Time PCR Kit

Product Overview

Human Parvovirus B19 is a single-stranded DNA virus that causes fifth disease, transient aplastic crisis, severe anemia, arthropathy, and fetal complications during pregnancy. Although commonly affecting children, infection can also cause significant morbidity in adults and immunocompromised individuals.

The Genes2Me B19-Q Real-Time PCR Kit is a highly sensitive in vitro diagnostic assay designed for qualitative detection of Human Parvovirus B19 DNA in clinical samples. Utilizing advanced TaqMan real-time PCR technology with integrated internal controls, the assay delivers rapid, accurate and reliable molecular diagnosis to support timely clinical intervention and improved patient care.

Targets:
Human Parvovirus B19 DNA
Technology:
Real-Time PCR (TaqMan)
Detection:
Qualitative (Detected / Not Detected)
Sample Type:
Whole Blood, Serum, Plasma
Certification:
CE-IVD
B19-Q

How the Assay Works

The B19-Q Real-Time PCR Kit employs TaqMan real-time PCR technology with B19-specific primers and fluorescent probes targeting Human Parvovirus B19 DNA. Detection is performed through the FAM channel, while the internal control detected in the HEX channel confirms successful nucleic acid extraction and PCR amplification. Positive and no-template controls validate assay performance and monitor contamination, ensuring reliable results.

Why Molecular Testing Matters for Human Parvovirus B19

Serological methods may not accurately identify acute infection in early stages or immunocompromised patients. Real-time PCR enables rapid and highly specific detection of Parvovirus B19 DNA directly from clinical specimens, reducing turnaround time and improving diagnostic confidence. Early molecular diagnosis is particularly valuable in pediatric infections, pregnancy, hematological disorders and transplant settings.

Sample Type & Reporting Output

Sample Type:
Whole Blood, Serum, Plasma
Reporting Output:
Qualitative Detection (Detected / Not Detected)
Targets Detected:
Human Parvovirus B19 DNA

Key Features & Benefits

High analytical sensitivity and specificity

Delivers 100% analytical sensitivity and specificity for accurate detection of Human Parvovirus B19 DNA.

Excellent clinical performance

Achieves 99% clinical sensitivity and 99.1% clinical specificity, ensuring reliable results for routine diagnostic testing.

Robust internal control

HEX-channel internal control validates nucleic acid extraction and PCR amplification, minimizing false-negative results.

Positive and no-template controls included

Built-in controls verify assay integrity, reagent performance, and contamination-free workflow in every run.

Low limit of detection

Detects as low as 100 copies/mL with a Ct cut-off of ≤35, supporting early infection diagnosis.

No cross-reactivity observed

Demonstrates no cross-reactivity with HSV-1, HSV-2, Cytomegalovirus, or HIV, ensuring high assay specificity.

Highly reproducible results

Precision studies show excellent repeatability and reproducibility, delivering consistent performance across runs and operators.

Compatible with major PCR platforms

Validated on RapiCycler 96, Bio-Rad CFX96, QuantStudio 5, and LightCycler 480 systems.

Applications

  • Clinical & Hospital Laboratories: Rapid molecular detection supporting accurate diagnosis and patient management.
  • Pediatric Care: Early detection of fifth disease and associated complications.
  • Prenatal & Maternal Health: Supports diagnosis of B19 infection associated with fetal complications.
  • Hematology Laboratories: Useful in unexplained anemia and aplastic crisis investigations.
  • Immunocompromised Patient Management: Supports diagnosis in transplant and oncology patients at risk of persistent infection.
  • Reference & Molecular Diagnostic Laboratories: Standardized PCR testing for routine and confirmatory diagnosis.

Analytical Performance

  • Analytical sensitivity 100% and analytical specificity 100%.
  • Clinical sensitivity 99% and clinical specificity 99.1%.
  • LOD: 100 copies/ml with Ct cut-off ≤35.
  • Internal control validates extraction and PCR performance.
  • No cross-reactivity with HSV-1, HSV-2, CMV and HIV.
  • 12-month shelf life under recommended storage conditions.
  • Rapid, sensitive and specific molecular detection for routine diagnostics.

Data Analysis and Report

B-19 Real Time PCR

B-19 Real Time PCR specific amplification plot of B-19 Positive Control (FAM Channel) along with Internal Control (HEX Channel)

Ordering Information

Commercial Name Old Cat No. New Cat No. Pack Size
B19-Q Real-Time PCR Kit G2M706521 G2M706521 50 Tests

Product Enquiry Form

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Since its inception in 2016, Genes2me has been constantly striving towards setting a benchmark in the diagnostics space by introducing premium quality (Made in India) diagnostic kits which are CE-IVD, ISO-13485:2016, and ISO 9001:2015 certified, assuring our clients of unparalleled quality and compliance with international standards.

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