Blood Culture

to diagnose neonatal sepsis

Diagnostic
Diagnostic
  • PREVENTION
  • DIAGNOSTIC
  • TREATMENT
  • OVERVIEW
  • TECHNOLOGY Characteristics
  • Blood Culture
    Representative Product

    GLOBAL ANNUAL DEATHS ASSOCIATED WITH NEONATAL INFECTION

    PERCENT (%)
    NUMBER

    Maternal

    N/A
    N/A

    Neonatal

    30%
    920,000

    Stillbirth

    N/A
    N/A

    Condition
    Neonatal sepsis can be due to a bacterial, fungal, or viral infection. Early onset sepsis, in the first 7 days, usually results from organisms acquired intrapartum, and symptoms can appear at or soon after birth. The most common organisms include group B streptococcus (GBS) and gram-negative enteric organisms (often E. coli), however organisms may vary according by location. Later onset infections are frequently nosocomial, and often due to foreign bodies (particularly central venous catheters). Preterm infants are more prone to infection and have fatality rates from infection 2-4 times higher than term infants.

    Mechanism of Action
    Approximately 0.5-1cc of blood is drawn antiseptically from the neonate. Samples are collected directly into a vial containing growth media, typically a liquid broth. Each vial is then incubated at 37C for 2-7 days and observed for growth. Positive cultures are then subcultured on a variety of media known to promote or inhibit the growth of specific organisms. Bacteria can also be Gram stained to help identify broad groups of bacterial organisms to direct antibiotic treatment. Even in high-resource settings, neonatal blood cultures can have low sensitivity because so little blood is drawn. At small blood volumes, only relatively high concentrations of bacteria are detectable. Positive results, therefore, are only evident when the disease has progressed to dangerous levels. For this reason, most caregivers presumptively treat for infection in advance of blood culture completion, and refine treatment based on blood culture results.

    Current use in High-Resource Settings
    Blood cultures are commonly taken using specialized bottles pre-filled with broth, color changing chemical indicators as well as barcoding used in a specific high volume, automated system. Samples are then loaded into incubators which monitor hundreds of bottles at once, automatically identifying positive cultures. Positive cultures are then manually removed and subcultured on different agar plates to identify the invasive organism. The process requires a microbiology lab and specialized technician. In labs where the number of samples is low, manual systems like the one pictured above may be used instead of the larger, automated systems.

    Application in Low-Resource Settings
    Given the infrastructure requirements of performing blood cultures, they are less accessible in low-resource settings. Blood cultures may be used to identify the presence of infection, but further testing may not be available to identify a specific organism. Until a rapid, point of care system is available, the majority of neonatal sepsis diagnosis (and especially in the community) will continue to rely on clinical signs. Bang et al. report that 2 of 7 clinical signs “predicted sepsis death sensitivity 100% and specificity 92%. Those seven signs are “reduced or stopped sucking; weak or no cry; limbs becoming limp; vomiting or abdominal distension; baby cold to touch; severe chest indrawing; umbilical infection.” Work is underway to develop clinical guidelines community health workers may be able to use to identify neonates in need of urgent care.
     

    REPRESENTATIVE DEVICES

    MAKE
    MODEL
    PRICE*
    TECH
    STATUS
    NOTES

    BioMerieux

    BacT/Alert 3d Signature
    $10,000
    Automated
    Marketed
    Fully automated incubation

    BD

    SEPTI-CHEK
    $12
    Manual
    Marketed
    Manual system, labor intensive

    BioMerieux

    BacT/Alert Pediatric FAN
    $6-$7
    Vial
    Marketed
    Collection vial for automated system

    Clinical

    Assessment
    N/A
    Observation
    Marketed
    Rapid and inexpensive

    * Prices are approximated. Actual pricing can, and will vary by marketplace and market conditions.

  • CHARACTERISTICS OF REPRESENTATIVE PRODUCT

    TECHNOLOGY CHARACTERISTICS

    OPERATIONAL PARAMETERS

    POTENTIAL OPPORTUNITIES FOR IMPROVEMENT

    SKILLS

    REQUIRED

    Intended end user
    Training required
    Time required per use
    Technician
    Days
    Days

    A rapid, point of care diagnostic for neonatal sepsis would be far preferable to blood culture, although may not be biologically feasible unless looking for a biomarker that does not require incubation.

    ENVIRONMENT/ INFRASTRUCTURE

    Power required
    Waste collection
    Complementary technologies required
    Temperature and storage
    Maintenance
    Wall power
    Biohazard
    Multiple

    Blood culturing is an infrastructure intensive task, requiring an incubator, multiple growth media, sterile swab/wire, Gram stain, microscope, phlebotomy equipment, and specially trained technicians. It is unlikely that this could be made available outside hospital settings, even after significant technological advances.

    COST

    Device Cost (Approx)
    Cost/course (Approx)
    $5-$15
    $5-$15

    OTHER

    Portability
    Regulatory
    Efficacy
    Not portable
    Although blood cultures are the gold standard for sepsis diagnosis, they are rarely available in time to treat a neonate.

    Additional devices required for impact: Antibiotics or other course of treatment depending on patient condition and blood culture results

Sources: AT Bang et al. Simple clinical criteria to identify sepsis or pneumonia in neonates in the community needing treatment or referral. Pediatr Infect Dis J. 2005 Apr;24(4):335-41. BD. Laboratory Prodcedure. BBL® SEPTI-CHEK™ Blood Culture BottleFor Use in the Culture of Microorganisms. Blood Culture Manual. TORONTO MEDICAL LABORATORIES / MOUNT SINAI HOSPITAL MICROBIOLOGY DEPARTMENT April 13, 2005. PATH. Rapid Screening Test for Newborn Sepsis: Report on a Landscape Analysis. Sept 13, 2007. MT Caserta. Neonatal Sepsis. The Merck Manual. October 2009.