| Cat. # | Description | Qty. | Unit |
| 252260 | Directigen™ H. influenzae type b Test Kit
(90 determinations) containing: one 1 mL bottle H. influenzae type b antibody, Reagent 1 , one 1.5 mL bottle Positive Control , one 1.5 mL bottle Negative Control , one 0.5 mL bottle control latex Reagent A , stirrers, plastic
|
1 | EA |
| Catalog # | Description | Quantity | Unit |
| 252260 |
Directigen™ H. influenzae type b Test Kit
(90 determinations) containing: one 1 mL bottle H. influenzae type b antibody, Reagent 1 , one 1.5 mL bottle Positive Control , one 1.5 mL bottle Negative Control , one 0.5 mL bottle control latex Reagent A , stirrers, plastic
|
1 | EA |
The diagnosis of bacteremia and meningitis, especially in young children, can be difficult. As many as 55% of children are seen by a physician and started on antibiotics before meningitis is detected.1 Detection of microbial antigens in the CSF is a rapid and helpful method for diagnostic microbiology. It may be the single most important test in cases of partially treated meningitis since Gram stain and culture may be negative. Detection of a specific antigen is a clinically significant finding and a valuable aid when choosing antimicrobial therapy.2
Haemophilus influenzae type b, Neisseria meningitidis, and Streptococcus pneumoniae have been reported to be the three causative agents responsible for approximately 84% of cases of bacterial meningitis.3
Group B Streptococcus and Escherichia coli K1 are major bacterial pathogens in the newborn.4-7 Strains of Group B streptococci and E. coli K1 frequently colonize in the vagina and/or rectum and may be associated with maternal septicemia and neonatal septicemia, pneumonia and meningitis.8 The E. coli K1 polysaccharide antigen has been shown to be structurally and immunologically similar to Neisseria meningitidis Group B antigen.9,10 The Directigen Neisseria meningitidis Group B Latex Reagent does not differentiate the two antigens, but can be useful in the diagnosis of neonatal E. coli K1 meningitis. The high morbidity and mortality associated with Group B streptococci and E. coli K1 in newborns make rapid, accurate identification of these organisms extremely important.4
Immunological methods for detecting characteristic exoantigens of pathogenic microorganisms in patient fluids (CSF, serum, urine) are typically faster than traditional methods such as culture. These techniques include counterimmunoelectrophoresis (CIE) and latex agglutination.11-14 The latex agglutination procedure has been found to be more rapid and sensitive than CIE in the detection of purified antigen.15-17
Include Control + and Control - testing with each batch of specimens tested as described in step 1, "Test Procedure."
Quality control requirements must be performed in accordance with applicable local, state and/or federal regulations or accreditation requirements and your laboratory's standard Quality Control procedures. It is recommended that the user refer to pertinent CLSI (formerly NCCLS) guidance and CLIA regulations for appropriate Quality Control practices.
Directigen Meningitis Individual Tests:
| Haemophilus influenzae type b: | ||||
| Reagent 1 | (1.0 mL), | Anti-H. influenzae type b Rabbit Polyclonal Antibody-Coated Latex Suspension, | ||
| Reagent A | (0.5 mL), | Control Latex, Rabbit Immunoglobulin-Coated Latex Suspension, each with 0.2% sodium azide (preservative). | ||
| Control + | (1.5 mL), | Polyvalent Positive Antigen Control, Group B Streptococcus, N. meningitidis Groups A, C, Y and W135, H. influenzae type b and S. pneumoniae antigens. | ||
| Control - | (1.5 mL), | Negative Antigen Control, glycine buffered saline, each with 0.2% sodium azide (preservative). | ||
| Streptococcus pneumoniae: | ||||
| Reagent 1 | (1.0 mL), | Anti-S. pneumoniae Rabbit Polyclonal Antibody-Coated Latex Suspension, | ||
| Reagent A | (0.5 mL), | Control Latex, Rabbit Immunoglobulin-Coated Latex Suspension, each with 0.2% sodium azide (preservative). | ||
| Control + | (1.5 mL), | Polyvalent Positive Antigen Control, N. meningitidis Groups A, C, Y and W135, H. influenzae type b and S. pneumoniae antigens. | ||
| Control - | (1.5 mL), | Negative Antigen Control, glycine buffered saline, each with 0.2% sodium azide (preservative). | ||
| Group B Streptococcus: | ||||
| Reagent 1 | (1.0 mL), | Anti-Group B Streptococcus Rabbit Polyclonal Antibody-Coated Latex Suspension, | ||
| Reagent A | (0.5 mL), | Control Latex, Rabbit Immunoglobulin-Coated Latex Suspension, each with 0.2% sodium azide (preservative). | ||
| Control + | (1.5 mL), | Polyvalent Positive Antigen Control, Group B Streptococcus, N. meningitidis Groups A, C, Y and W135, H. influenzae type b and S. pneumoniae antigens. | ||
| Control - | (1.5 mL), | Negative Antigen Control, glycine buffered saline, each with 0.2% sodium azide (preservative). | ||
| Neisseria meningitidis Group B / E. coli K1: | ||||
| Reagent 1 | (1.0 mL), | Anti-N. meningitidis Group B / E. coli K1 Mouse Monoclonal Antibody-Coated Latex Suspension, | ||
| Reagent A | (0.5 mL), | Control Latex, Mouse Immunoglobulin-Coated Latex Suspension, each with 0.2% sodium azide (preservative). | ||
| Control + | (1.5 mL), | Polyvalent Positive Antigen Control, N. meningitidis Groups A, B, C, Y and W135, H. influenzae type b, Group B Streptococcus and S. pneumoniae antigens. | ||
| Control - | (1.5 mL), | Negative Antigen Control, glycine buffered saline, each with 0.2% sodium azide (preservative). | ||
For in vitro Diagnostic Use.
Pathogenic microorganisms, including hepatitis viruses and Human Immunodeficiency Virus, may be present in clinical specimens. "Standard Precautions" 18 - 21 and institutional guidelines should be followed in handling all items contaminated with blood and other body fluids. Prior to discarding, sterilize specimen containers and other contaiminated materials by autoclaving.
Information shown on this page is a short summary extracted from the Package Insert, available as a PDF under the Related Documents section of this page.
