Umbrella Health Care Systems medical labs are state of the art lab services , we use several reference labs to bring you best price and precise lab work, you can feel free to order any Labtest you wish without any physician’s referral, all results are highly confidential and also no doctor visits required for any labtest.
Clinical Use Diagnose measles (rubeola) infection Clinical Background Measles (rubeola) is a highly contagious, acute viral illness. It is characterized by a febrile rash that appears about 14 days after exposure to the virus and follows fever, malaise, Koplick spots, and the 3 "C"s: cough, coryza (runny nose), and conjunctivitis. The Centers for Disease Control and Prevention (CDC) reports a recent resurgence in measles infection, owing to transmission from individuals from areas where disease is endemic, and decreased vaccination rates related to the anti-vaccination movement.1,2 Antiviral therapy is not available for measles, but timely diagnosis may allow clinicians to initiate supportive care sooner and limit transmission.3 The CDC recommends 2 complementary testing methods for diagnosing suspected measles infection: IgM antibody testing and real-time polymerase chain reaction (real-time PCR).3-5 IgM antibodies may be detected 3 days after rash onset; however, when testing is done too early, IgM levels can be low and cause false-negative results.6 False-positive IgM results can also occur owing to parvovirus B19, Epstein-Barr virus, and other viruses.7 Real-time PCR addresses some constraints of IgM antibody testing.4,5,8 Real-time PCR testing can detect viral RNA before IgM becomes detectable and can thus support a measles diagnosis earlier in disease progression.4,9 Furthermore, real-time PCR can detect nucleotide sequences specific to measles RNA, thus avoiding false-positive results caused by the detection of IgM antibodies to other viruses.7 Real-time PCR also performs better than viral culture. The sensitivity of culture is greatest for specimens collected within 3 days after onset of febrile rash (65% sensitivity) but falls below 10% after 10 to 14 days.5,6,8 In contrast, the sensitivity of real-time PCR for measles is 80% within 3 days of rash onset and remains above 50% as late as 10 to 14 days after onset.5,6,8 Individuals Suitable for Testing Individuals who present with symptoms of measles infection (ie, febrile rash, cough, coryza, conjunctivitis), especially those who are unvaccinated or have other risk factors such as recent international travel Method Real-time PCR-based amplification of extracted nucleic acids Interpretive Information A "detected" result confirms a measles diagnosis.4 A "not detected" result is consistent with the absence of measles infection but does not exclude the diagnosis, because real-time PCR is affected by the timing of specimen collection and other factors. If measles is suspected and rubeola virus RNA is not detected, consider measles IgM/IgG testing. Diagnosis of measles infection should not rely solely on the result of this test. Test selection and interpretation, diagnosis, and patient management decisions should be based on the physician's education, clinical expertise, and assessment of the patient. Methodology Immunoassay (IA) Reference Range(s) AU/mL Interpretation <13.50 Not consistent with immunity 13.50-16.49 Equivocal >16.49 Consistent with immunity The presence of measles IgG suggests immunization or past or current infection with measles virus. Alternative Name(s) Rubeola, IgG Antibodies,Measles, Immune Status
Clinical Significance Melaleuca (t21) IgE - This test quantifies an individual’s IgE response to melaleuca. It is an in vitro quantitative assay, which is intended to be used in conjunction with other clinical information to aid in the diagnosis of allergic diseases [1]. While allergen-specific serum IgE testing is considered comparable to skin testing in many instances, both the American Academy of Allergy, Asthma, and Immunology and the American College of Allergy, Asthma, and Immunology recognize that allergen-specific serum IgE testing may be preferred in some clinical situations. These include 1) the presence of widespread skin disease, 2) the recent use of antihistamines or other medications that can affect the results of allergy skin tests, 3) uncooperative patients, and 4) medical history suggesting that allergen skin testing would pose a significant risk for a serious allergic reaction [1]. A definitive clinical diagnosis of allergy should not be based on the results of any single diagnostic method, but should be made by a trained healthcare professional after all clinical and laboratory findings have been evaluated. Preferred Specimen(s) 0.3 mL serum Transport Container Serum Separator Tube (SST®) Transport Temperature Room temperature Specimen Stability Room temperature: 14 days Refrigerated: 14 days Frozen: 30 days
Methylenetetrahydrofolate Reductase (MTHFR) TEST What are the other names for this test? MTHFR gene variants, Methylenetetrahydrofolate reductase mutation, C677T and A1298C, MTHFR DNA assay, MTHFR gene polymorphisms 677T>C & 1298A>C mutations, MTHFR DNA testing What is an MTHFR gene test? A methylenetetrahyrdofolate reductase (MTHFR) gene test helps to see two common changes in your gene known as MTHFR. A change in this gene is called an MTHFR variant or MTHFR mutation. The DNA that you inherit from your parents contains genes in your cells. Genes help to regulate your physical appearance and the functions of your body. There are two copies of the MTHFR gene, one for each parent. Genes give specific instructions to develop the MHFR protein. This protein signals your body to utilize folate. A folate is a form of vitamin B, which is present in many foods. Your body requires folate and other vitamin B to decompose homocysteine, an amino acid. Your body usually decomposes homocysteine while little homocysteine stays in your blood vessels. Any change in an MTHFR gene indicates that MTHFR proteins do not instruct your body to use folate as per requirement. It leads to the deposition of large homocysteine amounts in your blood. According to some research, high homocysteine levels may damage your blood vessels from within. Damaged blood vessels may show a risk for blood clots, heart disease, and stroke. Your baby may experience neural tube defects during pregnancy. Neural tube defects are the defects of the brain, spine, or spinal cord during birth. But, most researchers are not sure that high homocysteine levels may actively lead to health disorders or diseases. What is the purpose of this test? An MTHFR gene test observes two specific common MTHFR changes known as C677T and A1298C. You may have no health issues if the change occurs in one or both of these genes. This test may perform as an individual or with a combination of genetic tests. This test may use to determine Whether or not any change in an MTHFR gene may lead to high homocysteine in your blood. Chance of forming blood clots, early heart, or disease of blood vessels. Some experts suggest the MTHFR gene test for this cause. You receive the same treatment if any change happens or not in your gene in the case of increased homocysteine. When do I need to take this test? In the usual case, medical professionals do not suggest an MTHFR gene test for the change in the common MTHFR gene. Your healthcare provider may recommend this test if you have conditions that include: Conducting a blood test that indicates high homocysteine amounts compared to recommend. Family history or relative history of an MTHFR gene change You and your family may already experience early heart or blood vessel disease. Your provider may also recommend this test if you use a medicine called methotrexate. Methotrexate helps to treat specific cancers, rheumatoid arthritis, and psoriasis (skin disease). The MTHFR protein guides your body to take this medicine accurately. Your provider may use the MTHFR gene test results to give the suitable dose to you. You can request an online order for this test. What is the procedure for this test? An MTHFR gene test is a blood test that requires a blood sample that includes the following steps: Sit in front of your provider. Be relaxed and stay in a fixed position. It is difficult for your provider to collect a blood sample if you do the muscle movement. Remove the portion of your cloth from the arm. A small needle will inject into a vein in your arm. A small amount of blood will collect in a test tube. Blood samples will store in the laboratory for examination of an allergy. You can go home for regular activities. This test takes at least five minutes. How do I get ready for this test? You may inform your provider about medicines, vitamins, and supplements you use. You do not need special preparation for the MTHFR gene test. Do not avoid any medication before consulting with a doctor. You may need to fast for several hours if your provider asks for additional blood tests. Are there any risks involved in this test? The MTHFR gene test does not have high risks when you give a blood sample. Veins differ from person to person. Some people may have difficulty providing a blood sample compared to others. Factors that link when the needle injects into a vein in your arm are: Extreme Bleeding Slight Infection Hematoma (Deposition of blood under the skin) Pain Bruising What do the test results indicate? The MTHFR gene test results depend on many factors, such as age, gender, and medical history. The test results may also slightly differ among laboratories. It is because each lab may use different methods for examination. The test results indicate one or both of the two common changes in the MTHFR gene. The MTHFR test results consist of positive or negative statements. Positive test results show that you experience an MTHFR change in one or both genes. You may not have any health problems if a change occurs in only one of your MTHFR genes. When you have high homocysteine levels and your MTHFR gene test indicates that you possess Two copies of the C677T gene change or only one copy each of C677T and A1298C - This gene change may lead to high homocysteine levels in your blood. Two copies of the A1298C gene change - This gene change does not involve large homocysteine amounts. Negative test results show you do not have any changes in the common MTHFR gene. If you see high homocysteine levels in your blood, this is due to other conditions. These include increasing age, low vitamin B levels, use of specific medications, hypothyroidism, kidney, or another disease. Understand your MTHFR test results here with professional healthcare. What additional tests do I need along with the MTHFR test? Your healthcare provider may recommend the homocysteine blood test to see their levels. You will have the same treatment for high homocysteine levels if it is or does not occur to the change in your MTHFR gene. If you have low homocysteine levels, your provider will ask for a folate or folic acid test to check for folate levels in your blood. You may need to take vitamin B supplements that contain folic acid. What else do I need to know about this MTHFR gene test? It is a popular myth that folic acid will not process if you see any or two copies of the MTHFR C677T gene. Your body will utilize folic acid supplements and all forms of folate in food in an effective way. Visit here to learn more about laboratory tests.
Clinical Significance Milk Component Panel - For use in the identification and severity of which specific milk protein a patient is allergic. This knowledge enables the clinician and the patient to make the correct treatment and lifestyle choices to mitigate exposure and reaction risk. Preferred Specimen(s) 1 mL serum Minimum Volume 0.5 mL Transport Container Serum Separator Tube (SST®) Transport Temperature Room temperature Specimen Stability Room temperature: 14 days Refrigerated: 14 days Frozen: 30 days Includes Alpha-lactalbumin (f76) IgE, Beta-lactoglobulin (f77) IgE, Casein (f78) IgE Methodology Immunoassay (IA) Alternative Name(s) ImmunoCAP®,a lactalbumin
MMR Test Measles, Mumps, and Rubella Antibody panel Does this test have any other names? Measles Immunity test, Mumps immunity test, Measles virus by RT-PCR, Measles blood test, Mumps blood test, Measles viral culture, Mumps virus by RT-PCR, Measles antibody IgM, IgG, Mumps antibody IgM, Rubeola, Parotitis, Rubeola Antibody, German Measles antibody, Hemagglutination inhibition (HAI), Rubeola antibody What is an MMR test? An MMR (Measles, Mumps, and Rubella) antibody test observes for antibodies in response to infectious diseases such as measles, mumps, and rubella. Antibodies are proteins developed by your immune system. Antibodies help to fight against bacteria, viral infections, or viruses. An MMR test helps diagnose whether you have had measles or mumps or are immune to these diseases because of recent viruses. Measles and mumps can transfer from one person to person. An MMR test is a blood test that helps to confirm both measles and mumps in your body or if you have immunity to these viruses. Rubella is called German measles, which spreads from the other virus. What are measles and mumps? Measles - This virus or infection is also known as rubeola. The measles virus damages the cells of your lungs and the back of the throat. It is a severe infection that can transfer through coughing or close contact with a contaminated surface with the virus. According to the CDC (Center for disease control and prevention), this virus may survive in the air for at least two hours whenever an infected person sneezes. Symptoms do not appear for the first few days. Measles may lead to symptoms about 1 to weeks after infection. Most people recover within a few weeks from measles. Some people may have measles, which leads to ear infections, diarrhea, or blindness. Severe viral infections may result in vitamin A deficiency, malabsorption, or a weak immune system. A high risk of miscarriage may occur during pregnancy if women experience measles infection. Mumps - This is a spreading viral infection that may transfer from one person to another by sneezing, sharing items, or close contact with surfaces with respiratory droplets or saliva. Mumps symptoms may appear about two to three weeks after the infection. Mumps is a low-risk infection compared to measles. . Mumps is light and develops limited illness for most people. In some people, this may lead to temporary or permanent deafness, inflamed testicles or ovaries, or pancreatitis (Inflammation of the pancreas). What are the tests included? The measles and mumps Antibody test helps to determine the following conditions: To diagnose the active measles or mumps infection. Active infection indicates that you are already experiencing a virus in your body. IgM antibody and Molecular tests are tests used to check for measles and mumps. IgM antibody test - IgM antibodies are proteins produced by your immune system when measles or mumps enter your body. This test searches for IgM antibodies in your blood. Molecular test - This test requires a sample of blood, fluid from your throat or nose, or urine to see measles or mumps. A PCR (polymerase chain reaction) comes under the molecular test. To identify your immunity to measles or mumps. If you ever had treatment of vaccination with measles and mumps, your body has IgG antibodies to prevent you from upcoming infection or for your remaining life. To control the disease of measles and mumps from society. It leads to resistance from transferring infections to another person by taking steps of awareness. When do I need an MMR test? Your healthcare provider may ask for this test to see your immunity to measles and mumps. You may need this test if you are Pregnant or future planning for pregnancy Attending school or going for a job that needs immunity proof. Working in a healthcare center where you may take exposure to the infected person. You may order the measles and mumps test if you experience symptoms of measles or mumps. Symptoms of measles Eyes color turn red Runny nose High fever Soreness in the throat Light sensitivity Small white spots within the mouth Rashes that appear on the face and transfer down to the legs and chest Cough Symptoms of Mumps Fever Muscle weakness or aches Headache Loss of appetite Swollen and painful cheeks Earache or pain Swelling with pain If you want to see your immunity to this measles or mumps, you can visit here for an MMR test. How do I need to prepare for this test? You do not need specific preparation for the MMR test. You can inform your provider about medicines, vitamins, and supplements you use. What is the method for this test? An MMR test may be performed with different methods. Antibody tests need a blood sample. A blood or a fluid sample from your mouth, nose, or throat is mostly used for molecular tests. For Blood test Your provider will ask for a blood sample for this test. Following are the steps of this test: Sit in front of your provider and remove your part of the cloth from one arm. Your provider will insert a small needle into the vein in your arm. A small amount of blood will collect in a test tube. Your blood sample will keep at the laboratory for examination. Daily activities can start after the test. This test generally takes five minutes. You can book an online order for an MMR test here. Swab test - You will provide a fluid sample from your nose, throat, or cheek. Your provider will use a specific wrap to collect a sample. Nasal aspirate or wash - A provider injects a saltwater solution into your nose and removes the sample by gentle suction. Your healthcare provider may ask to repeat tests if there is a chance for measles or mumps. You may also need a spinal test if measles or mumps lead to encephalitis or meningitis (Infection of fluid around the brain and spinal cord). Your healthcare provider injects a thin, hollow needle into your spine and collects a fluid sample for a spinal tap test. What are the risks of this test? An MMR test is a blood, swab, or nasal aspirate test having low risks. During a blood sample, you may experience slight pain or low risks when your provider injects a needle into your veins. These risks include Bruising Infection Low bleeding lightheaded feeling Dizziness A swab test may lead to feeling vomiting when your throat or nose cleanses. A nasal aspirate or wash may show a temporary feeling of discomfort. What do the test results mean? The MMR test results may vary on age, gender, medical history, and other factors. The test results may also slightly differ among laboratories. It is because each lab may use different methods for measurements. You can talk with a doctor to get information about your test results here. Negative test results do not indicate measles or mumps in your body. If you also had a negative antibody test, it shows that you do not have immunity to measles or mumps. Your body develops two rubella antibodies: IgM and IgG. The positive test results depend on what type of test you take: A positive molecular test (PCR) results indicate that you have the measles or mumps virus in your blood and current infection with it. A positive IgM antibody test results indicate that you currently have measles or mumps infection or have experienced infection in the past. A positive IgG antibody test result shows that you are immune to measles or mumps due to vaccination or recent infection. If your child experiences measles or mumps infection, they should stay home so that viruses do not transfer to other people. You can ask your provider when to come back for daily activities. What factors may affect the test results? An MMR test may affect if you conduct this test earlier or before symptoms of measles or mumps. What things may I need to know about an MMR test? According to the center for disease control and prevention (CDC), the recommended dose of vaccination against measles and mumps are: For children - 2 doses of the MMR (measles, mumps, and rubella) For adults - At least one dose if they are not immune to measles and mumps or if they are not pregnant. Two doses may require for some people. What additional tests do I need along with an MMR test? Your healthcare provider may ask for a spinal fluid test to diagnose mumps.
Clinical Significance Mountain Cedar (t6) IgE - This test quantifies an individual’s IgE response to mountain juniper. It is an in vitro quantitative assay, which is intended to be used in conjunction with other clinical information to aid in the diagnosis of allergic diseases [1]. While allergen-specific serum IgE testing is considered comparable to skin testing in many instances, both the American Academy of Allergy, Asthma, and Immunology and the American College of Allergy, Asthma, and Immunology recognize that allergen-specific serum IgE testing may be preferred in some clinical situations. These include 1) the presence of widespread skin disease, 2) the recent use of antihistamines or other medications that can affect the results of allergy skin tests, 3) uncooperative patients, and 4) medical history suggesting that allergen skin testing would pose a significant risk for a serious allergic reaction [1]. A definitive clinical diagnosis of allergy should not be based on the results of any single diagnostic method, but should be made by a trained healthcare professional after all clinical and laboratory findings have been evaluated. Preferred Specimen(s) 0.3 mL serum Minimum Volume 0.15 mL/allergen Transport Container Serum Separator Tube (SST®) Transport Temperature Room temperature Specimen Stability Room temperature: 14 days Refrigerated: 14 days Frozen: 30 days
Clinical Significance Mucor racemosus (m4) IgE - This allergen-specific IgE antibody test quantifies an individual’s IgE response to Mucor racemosus. It is an in vitro quantitative assay that is intended to be used in conjunction with other clinical information to aid in the diagnosis of allergic diseases [1]. While allergen-specific serum IgE testing is considered comparable to skin testing in many instances, both the American Academy of Allergy, Asthma, and Immunology and the American College of Allergy, Asthma, and Immunology recognize that allergen-specific serum IgE testing may be preferred in some clinical situations. These include 1) the presence of widespread skin disease, 2) the recent use of antihistamines or other medications that can affect the results of allergy skin tests, 3) uncooperative patients, and 4) medical history suggesting that allergen skin testing would pose a significant risk for a serious allergic reaction [1]. A definitive clinical diagnosis of allergy should not be based on the results of any single diagnostic method, but should be made by a trained healthcare provider after all clinical and laboratory findings have been evaluated. Preferred Specimen(s) 0.3 mL serum Minimum Volume 0.15 mL/allergen Transport Container Serum Separator Tube (SST®) Transport Temperature Room temperature Specimen Stability Room temperature: 14 days Refrigerated: 14 days Frozen: 30 days
Clinical Significance Mumps Virus Antibody (IgG), Immune Status - Mumps is an acute, usually self-limited systemic illness characterized by parotiditis, high fever and fatigue. One third of infections are asymptomatic. Preferred Specimen(s) 1 mL serum Minimum Volume 0.5 mL Transport Container Transport tube Transport Temperature Room temperature Specimen Stability Room temperature: 4 days Refrigerated: 7 days Frozen: 30 days Methodology Immunoassay (IA) Reference Range(s) AU/mL Interpretation <9.00 Not consistent with immunity 9.00-10.99 Equivocal >10.99 Consistent with immunityThe presence of mumps IgG antibody suggests immunization or past or current infection with mumps virus
NEISSERIA GONORRHOEA RNA What are the other names for this test? Gonorrhea test, Gonorrhea DNA Probe Test, Gonorrhea Nucleic Acid Amplification Test, NAAT, GC Test, What is a Gonorrhea Test? A gonorrhea test helps to observe for a gonorrhea infection in your body. Gonorrhea is the most spreading sexually transmitted disease (STD). The test may perform with fluid samples from the cervix, penis, urethra, or rectum. The urine sample may use to test for gonorrhea in men and women. This test observes for RNA of gonorrhea infection. RNA (Ribonucleic acid) is a nucleic acid available in all living cells having a similar structure to DNA. The function of RNA is to develop proteins through translation. RNA contains genetic data translated by ribosomes into different proteins for cellular processes, such as DNA repair and replication. What is the purpose of this test? A gonorrhea test screens and diagnoses whether you have a gonorrhea infection. This test may help to see symptoms of gonorrhea. Gonorrhea has symptoms similar to chlamydia, which is another STD. Symptoms may not develop among all people, but you may feel pain and burning during urination. Your healthcare provider may recommend both gonorrhea and chlamydia tests. When do I need this test? Many health organizations recommend a neisseria gonorrhea test for people ages 15 to 65. Most people do not have symptoms of gonorrhea infection. This test may suggest to: Women below 25: Yearly screening is required for gonorrhea if you are sexually active under 25. Women aged 25 or above: Yearly screening is required for gonorrhea if you are a woman with a high risk of gonorrhea infection aged 25 or above. Pregnant women: Gonorrhea infection may transfer from mother to child. This test is necessary for all pregnant women under 25. Yearly screening is required for pregnant women aged 25 or above with a high risk of infection. People with HIV: Yearly screening is required if you have experienced an HIV infection. Men having sex with men: If a man performs sex with another man, you may need screening for gonorrhea annually or every 3 to 6 months. Your healthcare provider may recommend the screening for gonorrhea infection due to several risk factors: Sex with a partner infected with an STD in the past Different sex partners A new sex partner within the last 60 days. Avoiding the use of a condom Sexual contact with sex workers You may need a gonorrhea test if your sex partner has gonorrhea. Signs and symptoms of gonorrhea may include: Bleeding from the vagina during periods Testicles or scrotum pain Bleeding or soreness in the anal Increased discharge from the vagina Leaking of fluids or itching from the anal or penis Soreness in the throat Burning or painful bowel movements Your provider may ask to take this test after three months of treatment to check for gonorrhea. Order an online test for gonorrhea infection here. What is the procedure for this test? Your provider will ask for a fluid sample from your infected body part for a gonorrhea test. Two ways are available to collect fluid sample are: A first-catch urine sample A sterile cup requires you to collect urine from the first part of the urine stream. You may need to stop urinating before the test for at least two hours to receive accurate results. A swab sample Your provider will collect cells from your genital area (the urethra or the vagina) with a special swab. You may feel some discomfort. Your rectum, throat, cervix, or eyes may swab. Your provider may ask you to swab yourself with specific instructions. You may receive your test results within a day. Some gonorrhea tests may provide results within 90 minutes or less. You can also order a swab or urine sample at home. You can send the sample to your laboratory after collecting the sample. You should avoid testing at home if you see symptoms of gonorrhea or your sex partner experiences gonorrhea. How do I get ready for this test? You may need preparation for a gonorrhea test, depending on the sample type. You should avoid antibiotic medicines and vaginal creams for 24 hours before your test. You can ask your provider about the specific preparation required for this test. Are there any risks involved in the test? This test does not have any risk. What do the test results indicate? The test results depend on many factors, such as age, gender, and medical history. The test results may also slightly differ among laboratories. It is because each lab may use different methods for examination. The negative results indicate that you have no gonorrhea in your fluid sample. A positive test result means that you have an infection with gonorrhea. When you have a positive test result, your provider will give you antibiotics to cure your infection. You need to follow specific instructions provided by your doctor to ensure that you have no gonorrhea. You can take guidance about your test results from a professional consultant. What factors may affect the test results? When your provider asks for a urine sample, urinating during 1 to 2 hours of the test may affect your test results. Some antibiotics may also change your test results. You may need to avoid vaginal creams within 24 hours of the gonorrhea test. What are the other tests that may detect gonorrhea infection? The tests may include finding gonorrhea infection are: Gonorrhea Nucleic Acid Amplification. This test helps to determine the DNA of the gonorrhea bacteria and is the most recommended test for gonorrhea. This test may be performed with a urine sample or swab collected from the infection site. Gonococcal Culture. It is the only test that determines the presence of infection with antibiotics. You may need this test if you have antibiotic resistance to gonorrhea. Rapid Gonorrhea Test. This test is often not performed. Some other tests may provide results within the same day. Gram Stain. This test observes specific cells that possess properties of gonorrhea infection under a microscope. This test uses urethral swabs and often performs in men having urinary problems or symptoms. If you have oral or anal sexual contact with a person, your provider may order a throat or rectal culture. You may also need tests to observe other STDs as well. What else do I need to know about a gonorrhea test? This test may help reduce health problems and resist the disease from spreading. You may avoid or prevent gonorrhea or any STD by not doing oral, vaginal, or anal sex. You can eliminate your risk of chlamydia if: You are sexually active with only one partner and possess negative test results for STD You use condoms each time you do sex.
Clinical Significance Neisseria gonorrhoeae RNA, TMA, Throat - Neisseria gonorrhoeae may infect the oral/pharyngeal cavity of sexually active individuals. Detection of this organism may be important for determining the risk for disease progression or transmission. Preferred Specimen(s) Throat swab submitted in an APTIMA® Combo 2 Transport Media Collection Instructions Use the ATPIMA® Unisex Swab Specimen Collection Kit (white label) or APTIMA® Vaginal Swab Specimen Collection Kit (orange label). Using a tongue depressor, insert the small, blue-shafted collection swab (Unisex Kit, NOT the larger white-shafted cleansing swab) or the small pink-shafted collection swab (Vaginal Kit) and vigorously rub the tonsils and the posterior pharynx. Carefully remove the swab without touching any area of the mouth. Remove the cap from the swab specimen transport tube and immediately place the swab into the transport tube. Carefully break the swab shaft at the score line. Re-cap the swab specimen transport tube tightly, label and ship to the lab. Note: Results from the APTIMA® Combo 2 Assay should be interpreted in conjunction with other laboratory and clinical data available to the clinician. The APTIMA® Combo 2 Assay is not intended for the evaluation of suspected sexual abuse or for other medico-legal indications. For a complete list of assay limitations we recommend that you review the manufacturers package insert, https://www.hologic.com/package-inserts/diagnostic-products/aptima-combo-2-assay-ctng. IMPORTANT: Please review the Specimen Collection instructions SPECIMEN COLLECTION GUIDES FOR APTIMA for this test Transport Container APTIMA® transport tube Transport Temperature Room temperature Specimen Stability Room temperature: 30 days Refrigerated: 30 days Frozen: 30 days Reject Criteria Transport tubes with 2 swabs • Transport tubes with non-APTIMA® swabs • Specimens in broken containers • Swab submitted in M4 transport media • Swabs submitted in Viral Culture Media (V-C-M) Methodology Transcription-Mediated Amplification (TMA) Assay Category The analytical performance characteristics of this assay have been determined by Quest Diagnostics. The modifications have not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes. Reference Range(s) Not detected Alternative Name(s) NG TMA,GC TMA,NG APTIMA®,GC APTIMA®
"Clinical Significance Neisseria gonorrhoeae RNA, TMA, Urogenital - Neisseria gonorrhoeae (gonococci) is the causative agent of gonorrhea. In men, this disease generally results in anterior urethritis accompanied by purulent exudate. In women, the disease is most often found in the cervix, but the vagina and uterus may also be infected. Preferred Specimen(s) 1 vaginal swab in Aptima® Transport Tube or 1 endocervical or urethral swab in Aptima® Transport Tube or 2 mL urine in Aptima® Transport Tube or 1 mL liquid cytology (PreservCyt®) Preservative (ThinPrep®) in Aptima® Transfer Tube or 0.5 mL SurePath™ Preservative Fluid in Aptima® Transfer Tube Minimum Volume 1 vaginal swab in Aptima® Transport • 1 endocervical or urethral swab in Aptima® Transport • 2 mL urine in Aptima® Transport • 1 mL PreservCyt® (ThinPrep®) in Aptima® Transfer Tube • 0.5 mL SurePath™ fluid in Aptima® Transfer Tube Collection Instructions Vaginal Swab: Follow instructions in the Aptima® Vaginal Swab Collection or Multitest Collection Kit (orange label). Endocervical or Urethral Swab: Follow instructions in the Aptima® Unisex Swab Specimen Collection Kit (white label). In females, to ensure collection of cells infected with N. gonorrhoeae, columnar epithelial cells lining the endocervix should be obtained. Excess mucus should be removed prior to sampling. Urine: Direct patient to provide a first-catch urine (a maximum of 20-30 mL of the initial urine stream) into a urine collection cup free of any preservatives. 2 mL of urine specimen must be transferred into the Aptima® Specimen Transport within 24 hours of collection and before being assayed. Use the tube provided in the urine specimen collection kit. The fluid (urine plus transport media) level in the urine transport tube must fall within the clear pane of the tube label. Labs performing cytology: Aliquot PreservCyt® ThinPrep® solution before performance of liquid based cytology testing. PreservCyt® ThinPrep®: Transfer 1 mL PreservCyt® ThinPrep® solution into Aptima® Specimen Transfer Tube (green label) or Aptima® Vaginal Collection or Multitest Collection Tube (orange label) or Unisex Swab Specimen Collection Kit (white label). SurePath™: SurePath™ fluid must be transferred to Aptima® tube within 4 days of collection. Transfer 0.5 mL SurePath™ solution into Aptima® Specimen Transfer Tube (green label) or Aptima® Vaginal Collection or Multitest Collection Tube (orange label) or Unisex Swab Specimen Collection Kit (white label). Note: Results from the Aptima® Combo 2 Assay should be interpreted in conjunction with other laboratory and clinical data available to the clinician. The Aptima® Combo 2 Assay is not intended for the evaluation of suspected sexual abuse or for other medico-legal indications. For a complete list of assay limitations we recommend that you review the manufacturers package insert, https://www.hologic.com/package-inserts/diagnostic-products/aptima-combo-2-assay-ctng IMPORTANT: Please review the Specimen Collection instructions SPECIMEN COLLECTION GUIDES FOR APTIMA for this test Transport Container Aptima® Transport Tube Transport Temperature Room temperature Specimen Stability PreservCyt(R) (ThinPrep®) in Aptima® Transport Tube Room temperature: 14 days Refrigerated: 30 days Frozen: 1 year Liquid cytology (Preservcyt® Preservative (ThinPrep®) Room temperature: 30 days Refrigerated: 30 days Frozen: 1 year SurePath™ Preservative Fluid Room temperature: 14 days Refrigerated: 14 days Frozen: Unacceptable Urine in Aptima® Transport Medium Room temperature: 30 days Refrigerated: 30 days Frozen: 1 year Swabs in Aptima® Transport Room temperature: 60 days Refrigerated: 60 days Frozen: 1 year Patient Preparation Urine: Patient should not have urinated within one hour prior to collection. Female patients should not cleanse the labial area prior to providing the specimen. Methodology Transcription-Mediated Amplification (TMA) Reference Range(s) Not detected Alternative Name(s) NG TMA,GC Aptima,Hologic,GC TMA,NG Aptima
Clinical Significance Neisseria gonorrhoeae, TMA (Alternate Target), Urogenital - Several methods are available for the detection of N. gonorrhoeae in clinical specimens. These methods include: Observation of gram-negative intracellular diplococci in gram-stained smears of urethral discharges from men and of endocervical secretions from women; Growth of N. gonorrhoeae from the urethra (men) or endocervix on selective culture media followed by demonstration of typical colonial morphology; and/or detection of N. gonorrhoeae with non-culture laboratory tests. A definitive diagnosis of gonorrhoea requires: Isolation of N. gonorrhoeae from the sites of exposure by culture; demonstration of typical colonial morphology, a positive oxidase test, and typical gram-negative morphology; And finally, a confirmation by specific identification methods. These confirmation methods may include acid production from carbohydrates, rapid enzyme tests, serologic assays, and tests for specific nucleic acids, such as is performed by the CT/NG APTIMA® TMA Assay. Preferred Specimen(s) 1 vaginal, endocervical or urethral swab collected in an APTIMA® Vaginal Swab Specimen Collection kit or Multi-Test collection kit, or Unisex swab specimen collection kit or 2 mL urine with no preservative transferred into an APTIMA® urine collection kit or 1 mL PreservCyt® (ThinPrep®) transferred into APTIMA® Specimen Transfer tube (green label) or APTIMA® Vaginal Swab Specimen Collection kit or Multi-Test collection kit Collection tube (orange label) Collection Instructions Swabs: Swab must be submitted in APTIMA® Vaginal Swab Specimen Collection kit or Multi-Test collection kit, or Unisex Swab Specimen Collection tube. Follow instructions in the APTIMA® Specimen Collection Kits for Vaginal, Endocervical and Urethral Swab Specimens package insert. In females, to ensure collection of an adequate specimen, columnar epithelial cells lining the endocervix should be obtained. To that effect, excess mucus should be removed prior to sampling by using the white shaft cleaning swab which is discarded after use. Collection Container: APTIMA® Vaginal Swab Specimen Collection kit or Multi-Test collection kit, or Unisex Swab Specimen Collection Kit. Urine: Urine must be submitted in APTIMA® Urine Specimen Collection tube within 24 hours of collection. The patient should not have urinated for at least one hour prior to specimen collection. Direct patient to provide a first-catch urine (approximately 20-30 mL of the initial urine stream) into a urine collection cup free of any preservatives. Collection of larger volumes of urine may result in specimen dilution that may reduce test sensitivity. Female patients should not cleanse the labial area prior to providing the specimen. Thus, a urine sample collected from a female for Chlamydia/GC TMA cannot be collected at the same voiding event as that urine which would be intended for bacterial culture. Remove the cap of the APTIMA® Urine Specimen Collection tube and transfer 2 mL of urine into the urine specimen transport tube using the disposable pipette provided. The correct volume of urine has been added when the fluid level is between the black lines within the clear pane on the urine specimen transport tube label. Collection Container: APTIMA® Urine Specimen Collection Kit. PreservCyt® (ThinPrep®): Transfer 1 mL of PreservCyt® (ThinPrep®) solution into APTIMA® Specimen Transfer tube (green label) or APTIMA® Vaginal Swab Specimen Collection Kit or Multi-Test collection kit Collection tube (orange label). IMPORTANT: Please review the Specimen Collection instructions SPECIMEN COLLECTION GUIDES FOR APTIMA for this test APTIMA® transport tube Transport Temperature Room temperature Specimen Stability Endocervical, urethral and vaginal swabs Room temperature: 60 days Refrigerated: 60 days Frozen: 1 year Urine in APTIMA® urine collection kit Room temperature: 30 days Refrigerated: 30 days Frozen: 1 year PreservCyt® solution specimen in APTIMA® Room temperature: 14 days Refrigerated: 30 days Frozen: 1 year