Quality Control; Performance Characteristics - BD ESwab Manual Del Usario

5. Smears may be fixed with heat or methanol. Methanol fixation may be preferable as it prevents lysis of red blood cells,
avoids damage to all host cells and results in a cleaner background.
6. Follow published laboratory reference manuals and guidelines for performing the Gram stain. If commercial Gram
stain reagents are used, it is important to comply with instructions in the manufacturer's product insert for performance
test procedure.
For further information or guidance on the preparation of specimen slides for microscopic analysis, for information on Gram
staining procedures and the interpretation and reporting of microscopic analysis, consult published laboratory reference
manuals. 16,21,22,24,31

QUALITY CONTROL

All lot numbers of the BD ESwab are tested for sterility and swab applicators are tested to ensure they are non-toxic to
bacteria. BD ESwab Liquid Amies transport medium is tested for pH stability and bio-burden using Gram stain microscopic
examination to ensure acceptable levels as defined in the Clinical and Laboratory Standards Institute (CLSI) Approved
Each production lot of BD ESwab is quality control tested before release for ability to maintain viable
Standard M40-A. 4
bacteria at both refrigerated temperatures (4–8 °C) and room temperature (20–25 °C) for specified time points with a panel
of aerobes, anaerobes and fastidious bacteria using both Roll-Plate and Swab Elution Methods.
studies also include an assessment of bacterial overgrowth at refrigerated temperatures (4–8 °C) which should
correspond to ≤1 log increase in growth at a specified time point. Procedures for quality control of bacteriology transport
devices using a quantitative Swab Elution Method and qualitative Roll-Plate Method are described in CLSI M40-A and other
publications. 4,5,7,8,32-34 If aberrant quality control results are noted, patient results should not be reported.
LIMITATIONS OF THE PROCEDURE
1. Condition, timing, and volume of specimen collected for culture are significant variables in obtaining reliable culture
results. Follow recommended guidelines for specimen collection.
2. BD ESwab is intend for use as a collection and transport medium for aerobes, anaerobes and fastidious bacteria such as
Neisseria gonorrhoeae.
3. BD ESwab Collection and Transport System is intended to be used with the medium tubes and swabs provided in the kit.
The use of tubes of medium or swabs from any other source are not qualified for use with BD ESwab and could affect
the performance of the product and laboratory test results.
EXPECTED VALUES
Results obtained will largely depend on proper and adequate specimen collection, as well as timely transport and processing
in the laboratory.

PERFORMANCE CHARACTERISTICS

In the routine clinical laboratory, the Roll-Plate Method is the primary means of inoculating swab transport devices onto
plated media. A limitation of the Roll-Plate Method
method; it is, at best, a semiquantitative approximation. On the other hand, quantitative viability performance methods
such as the Swab Elution Method
Swab Elution Method allows a quantitative measurement of the ability of a transport system to maintain viable organisms,
the Roll-Plate technique takes into consideration some mechanical variables of the direct swabbing action that exist in the
clinical laboratory, and which can influence the release of the sample onto culture plates. Because of this, both methods
of performing viability studies were used to determine the performance characteristics of the BD ESwab Collection and
Transport System.
The test procedures employed for determining bacterial viability performance were based upon the quality control methods
described in CLSI M40-A.
M40-A for establishing performance claims and quality control of swab transport systems and include a representative
panel of aerobes, anaerobes and fastidious bacteria. An additional group of organisms not required or specified by CLSI
M40-A were tested in order to provide further information on the survival of specific bacteria. Bacterial viability studies were
performed on the BD ESwab at two different ranges of temperature, 4–8 °C and 20–25 °C, corresponding to refrigerator
and room temperature, respectively. Swabs accompanying each transport system were inoculated in triplicate with 100 µL
of specific concentrations of organism suspension. Swabs were then placed in their respective transport medium tubes and
were held for 0 h, 24 h and 48 h. At the appropriate time intervals, each swab was processed according to the Roll-Plate or
Swab Elution Method.
Organisms evaluated were divided into three main groups (see note below):
1. Aerobes and Facultative Anaerobes:
Pseudomonas aeruginosa ATCC
Haemophilus influenzae ATCC 10211
2. Anaerobes:
Bacteroides fragilis ATCC 25285, Peptostreptococcus anaerobius ATCC 27337, Fusobacterium nucleatum ATCC 25586,
Propionibacterium acnes ATCC 6919, Prevotella melaninogenica ATCC 25845
3. Fastidious Bacteria:
Neisseria gonorrhoeae ATCC 43069
Additional organisms evaluated:
Enterococcus faecalis (vancomycin-resistant Enterococcus, VRE) ATCC 51299, Staphylococcus aureus (methicillin-resistant
Staphylococcus aureus, MRSA) ATCC 43300, Streptococcus agalactiae (Group B Streptococcus) ATCC 13813, Clostridium
perfringens ATCC 13124, Clostridium sporogenes ATCC 3584, Fusobacterium necrophorum ATCC 25286, Peptococcus
magnus ATCC 29328
4 do not reflect the standard protocol used in most clinical laboratories. Whereas the
4,5,7,8,32-34 The test organisms utilized in this study were those specifically prescribed in CLSI
® BAA-427, Streptococcus pyogenes ATCC 19615, Streptococcus pneumoniae ATCC 6305,
17,24,31
2,3,14,16,17,20,21
4 for bacterial viability performance testing is that it is not a quantitative
5
4 Viability performance