Intended Use
The ELISA Chlamydia pneumoniae IgM tests are quantitative and qualitative immuoassays for detection of human antibodies in serum or plasma to Chlamydia pneumoniae.
Contents of Kit
1. Break apart microtiter test strips each with eight antigen coated single wells, (altogether 96), 1 frame. The coating material is inactivated. 12 pieces
2. Standard serum (ready-to-use), Human serum in protein-containing phosphate buffer; negative for anti-HIV Ab, HBs-Ag (Hepatitis B-Virus surface antigen), and anti-HCV Ab; preservative: <0.1% sodium azide; coloring: Amaranth O. 2 × 2ml.
3. Negative control serum (ready-to-use), Human serum in protein-containing phosphate buffer; negative for anti-HIV Ab, HBs-Ag (Hepatitis B-Virus surface antigen), and anti-HCV Ab; preservative: <0.1% sodium azide; coloring: Lissamin Green V. 2ml
4. Anti-human IgM conjugate (ready-to-use), Anti-human IgM polyclonal antibody, Conjugated to alkaline phosphatase, stabilized with protein stabilization solution; preservative: <0.1% methylisothiazolone, <0.1% bromnitrodioxane. 13ml
5. Washing solution concentrate (sufficient for 1000ml), Sodium chloride solution with Tween 20 and 30mM Tris/HCl, pH 7.4; preservative: <0.1% sodium azide. 33.3ml
6. Dilution buffer (ready-to-use), Protein-containing phosphate buffer with Tween 20; preservative: <0.1% sodium azide; coloring: 0.01g/l bromphenol blue, 2 × 50ml
7. Stopping solution (ready-to-use), <0.1N sodium hydroxide, 40mM EDTA. 15ml
8. Substrate (ready-to-use), Para-nitrophenylphosphate in solvent-free buffer; preservative: <0.1% sodium azide. 13ml
General Description
Chlamydiae are gram-negative intracellular bacteria. The following species cause disease in humans: Chlamydia trachomatis, Chlamydia pneumoniae, and Chlamydia psittaci. Chlamydia life cycle alternates between two distinct morphological forms: elementary bodies (EB) and reticular bodies (RB). The extracellular EBs are metabolically inert and are able to infect host cells where they transform into the metabolically active RBs. They multiply, recondense into EBS, and are released from the host cells to initiate another round of infection.
The different Chlamydia species have varying strategies to infect their human hosts and produce distinct diseases associated with each species. C. trachomatis is one of the most common sexually transmitted diseases, causing urethritis and cervicitis, but it may also, depending on the route of entry, result in conjunctivitis or pneumonia (newborn pneumonia). Ornithosis or psittacosis, resulting from infection with C. psittaci, manifests as a feverish pneumonia and may manifest systemically as myocarditis and/or endocarditis with possible fatal consequences. Infection with C. pneumoniae is generally asymptomatic or produces mild general symptoms such as pharyngitis, hoarseness, bronchitis, and coughing. Symptoms can range from acute pharyngitis, sinusitis, and bronchitis to pneumonia, myocarditis and endocarditis. Occasionally immunopathological syndromes can result, such as Erythema nodosum, arthralgia, Guillain-Barré-Syndrome, and myalgia. In addition, chronic infection with C. pneumoniae has been associated with asthma, COPD, arteriosclerosis, and cardiovascular disease. It is possible that C. pneumoniae is responsible for disease onset, leaving an infected individual susceptible to other pathogens, such as Streptococcus pneumoniae.
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