hologic aptima swab specimen collection kit

Item number: dc80025. For clinician or patient collected Vaginal specimens ONLY the Gen-Probe Aptima Vaginal Swab Collection Kit or Multi-test kit (Pink swab and Orange labeled tube) should be used. Limit 5. Item Name: Aptima Multitest swab specimen collection kit. Unit of measures: Each. Do not hold shaft below score line. Only use the provided swab contained in the Multitest kit and place the swab Each. Indication(s) for use: Same as the Intended Use 3. It is the sole responsibility of the laboratory to read and understand the appropriate package insert and comply with . If the soft tip is touched, laid down, or dropped, discard and get a new Aptima Multitest Swab Specimen Collection Kit. Download (107.65 KB) Aptima® Multitest Swab Specimen Collection Kit for SARS-CoV-2 Specimen Collection. 1162) GEN . 2. Remove cap from Urine Specimen Transport Tube and, using the disposable . No. Discard this swab. 5. Collection Instructions. of performance. This is now known as the "processed urine specimen." Patient should not have urinated for at least 1 hour prior to . These swabs are contained in the APTIMA Collection Kit. Aptima® Multitest Swab Specimen Collection Kit Clinician collection procedure guide For throat swab specimens Carefully insert the swab into the throat ensuring contact with bilateral tonsils (if present) and the posterior pharyngeal wall, then withdraw the swab without touching the inside of the cheeks or tongue. Re-cap the swap specimen transport tube tightly. Aptima® Multitest Swab Specimen Collection Kit PRD-03546 Aptima® Urine Specimen Collection Kit No. Recap the swab specimen transport tube tightly, label and ship to the lab. Do not hold the shaft below the score line. Item Description: For use in collection of eye/ocular (corneal/conjunctiva), oral/mouth, rectal and vaginal samples. Collection Instructions: Peel open the swab package. Do not touch the soft tip or lay the swab down. Aptima ® Unisex Swab Specimen Collection Kit . Aptima Unisex Swab Specimen Collection Kit for Endocervical and Male Urethral Swab Specimens. Insert the small, blue shaft collection swab (NOT the larger white shaft cleaning swab) approximately 3-5 cm into the rectum. While holding the swab in . MSDS: The swab to use is an orange Aptima multitest swab specimen collection kit for patient-collected specimens. Commercial Distribution Status: In Commercial Distribution. Re-cap urine specimen transport tube tightly. Do not spill the contents of the tube. Hologic Aptima ® Collection Kit supplied must be used to collect patient specimens for this test. swab. Hold the swab in your hand as shown in Diagram 2, placing your thumb and forefinger in the middle of the swab shaft covering the score line (black line). Four vaginal swabs were collected from each subject with the following: BD Affirm™ VPIII Ambient Temperature Transport System (ATTS), BD MAX™ UVE Specimen Collection Kit, Hologic Aptima® Vaginal Swab Specimen Collection Kit, and BD ESwab™ collection and transport system (ESwab). Vagina Swabs: Use APTIMA® vaginal swab collection kit available from Laboratory. If tube contents are spilled, discard and replace with a new Aptima Multitest Swab Specimen Collection Kit. Obtain specimen using a APTIMA® swab specimen transport tube. The Aptima BV assay is provided as a 100-test kit. diagnostic.solutions@hologic.com. Orders submitted to NVRL via the online Swab Shop may not be completely filled. 6 The Aptima ® Multitest Swab Specimen Collection Kit is indicated for use with the following assays: FDA-Cleared Assays Aptima Combo ® 2 Assay (CT/NG) Aptima ® Mycoplasma genitalium Assay Aptima ® Trichomonas vaginalis Assay Aptima ® HSV 1 & 2 Assay It is the sole responsibility of the clinician/laboratory to read and understand the appropriate package insert and comply . Specimen Transported Temperature: at 2 to 30 °C Submit only 1 of the following specimens: Hologic Aptima ® Collection Kit supplied must be used to collect patient specimens for this test. Location: Central Lab Supply Room - F92. Vaginal Swab Specimens (Diagnostic) This swab collection device is designed to collect specimens for assays that require vaginal samples, such as bacterial vaginosis, for symptomatic women for diagnostic purposes.3 The APTIMA® vaginal swab is used for tests that require vaginal sampling (ie, bacterial vaginosis). Hold swab, placing thumb and forefinger in the middle of shaft covering black score line. If soft tip is touched, swab laid down, or swab is dropped, use a new Hologic® APTIMA® Vaginal Swab Specimen Collection Kit. Manufacturer name: Hologic. Item Name: Aptima Multitest swab specimen collection kit. Remove swab, and hold, placing thumb and forefinger in middle of swab shaft. Hold swab, placing thumb and forefinger in the middle of swab shaft over black score line. Vaginal Swab: Place pink swab in Swab Specimen Transport Tube, break shaft off at scoreline, then recap tube. Follow instructions in the Aptima® Vaginal Swab Collection or Multitest Collection Kit (orange label). Product Usage: The APTIMA Urine Specimen Collection Kit for Male and Female Urine Specimens is for use with APTIMA assays. These samples can be collected using either the new Aptima Multitest Swab Specimen Collection Kit or commercially available viral transport media. Do not touch the soft tip or lay the swab down. Carefully break the swab shaft at the score line; use care to avoid splashing of contents. swab. Aptima ® Unisex Swab Specimen Collection Kit . Immediately place the specimen collection swab into the transport tube. It is also intended for use in sampling other previously collected specimens for processing, extraction, and analysis with other Hologic products. 301040 Aptima® Unisex Swab Specimen Collection Kit NO. Do not spill tube contents. Insert colelction swab (Blue shaft) and rotate for 15 to 30 . Unit of measures: Box of 50. Unit of measures: Box of 50. between black fill lines • Transport and store processed urine specimens in the Aptima urine specimen transport tube between 2˚C to 30˚C until . Hologic has announced a rebranding of the Aptima© Vaginal Swab Collection Kit to the Aptima© Multitest Swab Specimen Collection Kit which is intended to be utilized to collect patient samples for use with multiple Aptima© assays and with multiple sample types. While holding swab in hand, unscrew tube cap. 4. Partially open swab package and remove swab. vulvovaginal, eye, anal, throat -vulvovaginal swab (clinician or self- collected) is preferred site Remove cap, insert swab, snap at black line re-cap tube firmly Do not pierce foil cap Only use pink shaft swab provided recall of aptima urine specimen collection kit According to Health Canada (via FOI) , this recall involved a device in Canada that was produced by GEN-PROBE INCORPORATED DOING BUSINESS AS HOLOGIC INC. . 3. Do NOT use the cleaning swab (White swab) to collect sample and insert into the collection tube, this . Do not touch the soft tip or lay the swab down. Aptima HOLOGIC Swab. Hologic (Aptima) Unisex Swab Kit (301041) Unisex Swab Specimen Collection Kit w/ 2.9mL vial of media and woven collection swab (75mm breakpoint) Note : Kit also contains a cleaning swab that is not suitable for testing. The Aptima HSV 1 & 2 assay is a nucleic acid amplification test for the qualitative detection and differentiation of HSV types 1 and 2 in clinician-collected swab specimens from anogenital skin lesions. Do not touch the soft tip or lay the swab down. Do not hold the shaft below the score line. For use with Aptima assays. It is the sole responsibility of the laboratory to read and understand the appropriate package insert and comply with . Materials Provided . With just one sample, the Aptima Multitest Swab simplifies testing and provides more answers for sexual and vaginal health. Rectal swab : Use the APTIMA Unisex Swab Specimen Collection kit (white label on Swab Specimen Transport Tube). The flocked swab has short nylon fibers glued to the end of a plastic shaft and has been used as a collection device for the diagnosis of many infections by NAAT. Assay Menu CT/NG Mycoplasma genitalium Zika Virus † 4 AW-15641-REG Rev. Valid Date. Item Description: For use in collection of specimens for Mycoplasma testing referred to LabCorp. Container/Tube: APTIMA Unisex Swab for Male Urethral Specimens. When to use. Manufacturer name: Hologic. Flexible ‎ Can be used to collect samples from a variety of specimen collection sites.2 Versatile ‎ Detect up to 7 infections and disease states with just one vaginal swab.3-6 Reliable ‎ Urine samples can miss Test information: Mycoplasma swab, NAA, genital (13664) Manufacturer name: Hologic. Collection Instructions: Peel open the swab package. Aptima Unisex swab specimen collection kit (LabCorp) Item Name: Aptima Unisex swab specimen collection kit (LabCorp) Item number: LC_67677. Aptima® Multitest Swab Specimen Collection Kit Clinician collection procedure guide For female and male anogenital skin lesion specimens Partially open swab package and remove swab. If the soft tip is touched, laid down, or dropped, discard and get a new Aptima Multitest Swab Specimen Collection Kit. Item Description: For use in collection of eye/ocular (corneal/conjunctiva), oral/mouth, rectal and vaginal samples. Document Revision. Fluid is . Use the ATPIMA® Unisex Swab Specimen Collection Kit (white label) or ATPIMA® Vaginal Swab Specimen Collection Kit (orange label) or Multi-test Collection Kit. Carefully insert the swab into the vagina about 2 inches (5 cm) past the introitus and gently rotate the swab for 10 to . Specimen Type: Endocervical specimens. Do not touch the soft tip or lay the swab down. The Aptima Unisex Swab Specimen Collection Kit for Female Endocervical and Male Urethral Swab Specimens is for use with Aptima assays. "Self-collected vaginal swab specimens are equivalent in sensitivity and specificity to those . Item Description: For use in collection of female endocervical or male urethral specimens. Male collection . diagnostic.solutions@hologic.com. Male collection . Discard this swab. Hologic APTIMA Multitest Swab Specimen Collection Kit Female - pink swab and orange label tube All ?STI sites e.g. Container/ Tube: Hologic APTIMA Unisex Swab or Hologic APTIMA Urine transport tube supplied in the Hologic APTIA Collection Kits Type: Female endocervical swab, male urethral swab, female and male urine, throat or rectal swab specimens, collected using Hologic APTIMA Specimen Collection Kits Volume: Inoculated swab in 2.9 mL of transport media or 2 mL urine added to 2.0 mL of transport media • Processed urine specimens should be assayed with the Aptima assay for CT, GC and/or TV within 30 days of collection. 1Patient-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. If the soft tip is touched, laid down, or dropped, discard and get a new Aptima Multitest Swab Specimen Collection Kit. The Aptima Unisex Swab Specimen Collection Kit is used for the collection of female endocervical or male urethral swab specimens. Do not touch the soft tip or lay the swab down. Hologic® is working on fulfilling backorders for the Aptima® Unisex collection kits but has not been able to meet the demand across the nation. or dropped, discard and get a new Aptima Multitest Swab Specimen Collection Kit. Hologic Aptima Multiest Swab or Hologic Aptima Unisex Collection Swab Endocervical swabs in Aptima Unisex Swab Specimen Collection Kit or Aptima Multitest Specimen Collection Kit The collection kit contains the following: One unisex collection swab One cleaning swab One Aptima transport tube containing 2.9 mL of transport media Container/Tube: APTIMA Unisex Swab for Endocervical Specimens. HPV Collection and Transport Kit APTIMA® Multitest Swab Transport (preferred for NuSwabSM testing) APTIMA® Unisex Swab Transport Submit the APTIMA® urine transport with yellow label for amplified detection of Ct, Ng, Tv, M hominis, Ureaplasma, and/or M genitalium from male or female first-void urine specimens. Vaginal swab is the CDC's preferred collection method. Precautions. Partially peel open swab package. The vaginal swab specimen collection kit is not for home use. The Aptima® Combo 2 Assay is not intended for the evaluation of suspected sexual abuse or for other medico-legal indications. Multitest Swab Specimen Collection Kit. Vaginal swab specimens must be transported to Alberta Precision Labs in the provided swab specimen transport medium and tube within 72 hours of collection Store at room temperature Source images courtesy of HOLOGIC, Inc, Aptima® Multitest Swab Specimen Collection Kit Clinician Collection Procedure Guide for Vaginal Swab Specimens DS-01552-001 . Catalog #301040. Hologic provides this collection procedure guide as a general informational tool only; it is not an affirmative instruction or guarantee . 1. Collection Instructions: Partially peel open the swab package. In females, specimens should be obtained from the cervix or vagina; Male Urethral Swab: Use Hologic APTIMA® unisex swab specimen collection kit available from Laboratory. Device IDs: 15420045512849 ( Primary) Catalog Number: PRD-05571; PRD-05572; PRD-05572B. MSDS: Material safety data sheet. If the soft tip is touched, laid down, or dropped, discard and get a new Aptima Multitest Swab Specimen Collection Kit. Swab: Swab specimen must be collected using an APTIMA Collection Unisex Swab Specimen collection kit. If the contents of the tube are spilled, use a new Aptima Multitest Swab Specimen Collection Kit. The Aptima swab has Dacron fibers wrapped around the end of a plastic shaft and is cleared for use in the AC2 assay following transportation in Aptima specimen transport media. 3. Hold the swab so that the thumb and forefinger are positioned in the middle of the shaft covering the score line. While holding the swab in . Collection Info. Unisex Swab: Place blue swab in Swab Specimen Transport Tube, break shaft off at the scoreline, then recap tube. Endocervix (Females Only) 1. No. Nasal Specimen Collection May 18, 2020 Effective May 18, 2020, PathGroup will accept nasal (anterior nares) specimen collection for the SARS-CoV-2, RNA test (PathGroup Test Code: COVID19) when collected with the Hologic® Aptima® Multitest Swab Specimen Collection Kit. 2. Do not touch the soft tips or lay the swabs down. 002. Male collection . of performance. Specimen Type: Endocervical specimens. and Urethral Swab Specimens (Cat. About Aptima Combo 2. When collecting multiple specimens from the same patient, the tube label provides . During limited supply of Viral Transport Media for Nasopharyngeal collections, the following alternate instructions for the collection of Throat and Nares with the Aptima Multitest Swab Specimen Collection Kit. Alternative Specimen(s) Rectal swab in APTIMA® Unisex Swab Collection Kit. Do not touch the soft tips or lay the swabs down. The APTIMA Urine Specimen Collection Kit is intended to be used for the collection and transport of male or female urine specimens. Code Information. Container/Tube: APTIMA Unisex Swab for Endocervical Specimens. Remove excess mucus from the cervical os and surrounding mucosa using the cleaning swab with the white shaft. The laboratory issues specific collection kits for Chlamydia/GC testing using the Aptima Hologic Panther. If the soft tip is touched, the swab is laid down, or the swab is dropped, request a new Aptima Multitest Swab Specimen Collection Kit. Aptima . Vaginal swab is the CDC's preferred collection method for chlamydia and gonorrhea. Do not touch the soft tips or lay the swabs down. Urine ( male and female) should be collected using the yellow urine Aptima collection kits. Each. 301041. Company Name: Hologic, Inc. Hologic provides this collection procedure guide as a general informational tool only; it is not an affirmative instruction or guarantee of performance. Hold the swab, placing thumb and forefinger in the middle of the shaft covering the black score line. While holding the swab in the same hand, unscrew the cap from the tube. Note: Urethral swabs may cause discomfort to male patients, urine is an appropriate specimen . N. Expiration dates listed on the Panther Fusion Specimen Lysis Tubes, Hologic Specimen Lysis Tubes, the Aptima Multitest Collection Kit, the Aptima Unisex Swab Specimen Collection Kit . For use in collection of female endocervical or male urethral specimens for Mycoplasma testing referred to LabCorp. If the soft tip is touched, laid down, or dropped, discard and use a new Aptima Multitest Swab Specimen Collection Kit. There are 4 boxes that make up the assay master kit. Hologic provides this collection procedure guide as a general informational tool only; it is not an affirmative instruction or guarantee . Aptima Multitest Swab Specimen Collection Kit. supplies the product, Hologic®, diverted their supply chain resources to COVID-19 reagents and collection supplies. Item number: dc152.5. specimen collection. Unit of measures: Box of 50. the PreservCyt Solution, patient-collected vaginal swab specimens,1 and male urine specimens. Do not touch soft tip or lay swab down. Carefully insert the specimen collection swab (with the blue shaft) 2 to 4 cm into the urethra. Preferred Specimen(s) Rectal swab in an APTIMA® Combo 2 Transport Media. 50 Aptima Unisex Swab Specimen Collection . While holding swab in your hand, unscrew . Collection Kit / Aptima Specimen Transport Tubes, Aptima Cervical Specimen Collection and Transport Kit Recommended Use In vitro diagnostic Details of the supplier of the safety data sheet Supplier Address Hologic, Inc. 10210 Genetic Center Drive San Diego, CA 92121-4362 Emergency Telephone - United States of America 24 Hour Emergency Phone . Document type. The Aptima Vaginal Swab Specimen Collection Kit is intended to be used for clinician and patient collection of vaginal swab specimens. Remove excess mucus from the cervical os and surrounding mucosa using the cleaning swab with the white shaft. Aptima® Specimen collection and processing guide After sample collection, immediately hold swab in the transport tube so the black score line is at top of the tube. of performance. Patient-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. Peel open the swab package. Aptima Multitest swab specimen collection kit. to specimen collection. • After collection, transport and store processed urine specimens in the Aptima urine specimen transport tube between 2˚C to 30˚C until tested. Droplet / Contact Precautions. Version or Model: KIT,APTIMA COMBO 2,250T,RT,CEIVD-UPDATED. The Aptima Vaginal Swab Specimen Collection Kit is for use with Aptima assays. A. Insert the specimen collection swab (orange shaft swab) into the rectum Specimen Collection Instructions of clinician and patient self-collected vaginal swabs, clinician collected rectal and throat swabs for N. gonorrhoeae, and C. trachomatis testing using HOLOGIC APTIMA® Multitest Swab Collection Kit COVID-19 Diagnostic Specimen Collection, Packaging and Shipping Guidance for Laboratories and CHDs o Oropharyngeal (OP) (e.g., throat) swab collected by a healthcare professional: Hologic Aptima Multitest collection kits are preferred for OP collection and submission. 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