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BD MAX UVE Specimen Collection Kit


SUMMARY AND EXPLANATION OF THE PROCEDURE

The BD MAX UVE Specimen Collection Kit consists of a BD MAX Specimen Collection Swab, a graduated transfer pipette and a BD MAX UVE Sample Buffer Tube. Instructions for the use of the collection kit are provided below.


Urine Specimen Collection Procedure

Urine Specimen Collection

1. The patient should not have urinated for at least 1 hour prior to specimen collection.

2. Collect the specimen in a sterile, preservative-free specimen collection cup.

3. The patient should collect the first 20–60 mL of voided urine (the first part of the stream - not midstream) into a urine collection cup.

4. Cap and label the urine collection cup with patient identification and date/time collected.


Transfer of Urine Specimen to the BD MAX UVE Sample Buffer Tube


NOTE: Urine should be transferred from the collection cup to the BD MAX UVE Sample Buffer Tube within 4 hours of collection if kept at 2–30 °C or within 24 hours of collection when stored at 2–8 °C.

1. Uncap the BD MAX UVE Sample Buffer Tube. Use the graduated transfer pipette to mix the urine specimen gently in the collection cup and transfer approximately 1 mL into the BD MAX UVE Sample Buffer Tube.

NOTE: Use the graduations on the transfer pipette as a guide. Do not overfill or underfill the tube.

2. Discard the transfer pipette in a biohazard waste container.

NOTE: The transfer pipette is intended for use with a single specimen.

3. Tighten the cap securely on the BD MAX UVE Sample Buffer Tube.

4. Invert the BD MAX UVE Sample Buffer Tube 3–4 times to ensure that the specimen and reagent are well mixed.

5. Label the BD MAX UVE Sample Buffer Tube with the patient identification and date/time collected.


NOTE: Be careful not to obscure the barcodes on the tube. Do not use a preprinted label


6. Use the viewing window on the BD MAX UVE Sample Buffer Tube label to ensure urine specimen was added to the tube.

7. Transport to the testing laboratory following the storage and stability requirements above.


Endocervical Swab Specimen Collection Procedure


NOTE: Endocervical swab specimens must be transferred to the BD MAX UVE Sample Buffer Tube within 2 hours of collection.

1. Remove the sterile swab from its sheath, taking care not to contaminate the tip or shaft. If the swab tip is touched or if the swab is laid down, discard it and use a new collection kit. Check for presence of the swab tip. If the swab has no tip, discard it and request a new BD MAX UVE Specimen Collection Swab.

2. Holding the swab by the white cap, insert it into the cervical canal and rotate for 15–30 s.

3. Withdraw the swab carefully, avoiding contact with the vaginal mucosa.

4. Uncap the BD MAX UVE Sample Buffer Tube and fully insert the swab into the tube so that the tip is at the bottom (refer to Figure 1).

5. Grasping the swab by the cap, carefully break the swab shaft at the score mark. Use caution to avoid splashing or contamination of the tube contents.

6. Tighten the cap securely on the BD MAX UVE Sample Buffer Tube. In the event that the swab is too long to allow closing the tube securely, perform specimen collection again using a new swab.

7. Label the BD MAX UVE Sample Buffer Tube with patient information and date/time collected. NOTE: Be careful not to obscure the barcodes on the tube.

8. Use the viewing window on the BD MAX UVE Sample Buffer Tube label to ensure the swab specimen was added to the tube.

9. Transport to the testing laboratory following the storage and stability requirements above.


Clinician Collected Vaginal Swab Specimen Collection Procedure

Clinician Instructions

1. Remove the sterile swab from its sheath, taking care not to contaminate the tip or shaft. Do not lay the swab down on any surface. If the swab tip is touched or if the swab is laid down, discard it and use a new collection kit. Check for presence of the swab tip. If the swab has no tip, discard it and request a new BD MAX UVE Specimen Collection Swab.

2. Hold the swab by the white cap.

3. Gently slide the swab no more than 2 inches into the vagina. If the swab does not slide easily, gently rotate the swab while it is pushed. Make sure the swab touches the walls of the vagina so that moisture is absorbed by the swab.

4. Rotate the swab for 10–15 s.

5. Withdraw the swab without touching the skin.

6. Uncap the BD MAX UVE Sample Buffer Tube and fully insert the swab into the tube so that the tip is at the bottom (refer to Figure 1).

7. Grasping the swab by the cap, carefully break the swab shaft at the score mark. Use caution to avoid splashing of the tube contents.

8. Tighten the cap securely on the BD MAX UVE Sample Buffer Tube. In the event that the swab shaft is too long to allow closing the tube securely, perform specimen collection again using a new swab.

9. Label the BD MAX UVE Sample Buffer Tube with patient information and date/time collected. Note: Be careful not to obscure the barcodes on the tube.

10. Use the viewing window on the BD MAX UVE Sample Buffer Tube label to ensure the swab specimen was added to the tube.

11. Transport to the testing laboratory following the storage and stability requirements above.



Figure 1: Transfer of Swab Specimens to the BD MAX UVE Sample Buffer Tube


1. Fully insert the swab into 2. Carefully break the shaft

the tube so that the tip is at the score mark

at the button

3. Tightly re-cap the tube. 4. Label tube with patient information. Do not use

a preprinted label

STORAGE AND STABILITY

Specimen Type Transport and/or Storage

Prior to Transfer into BD MAX UVE Sample Buffer Tube In BD MAX UVE Sample Buffer Tube prior to Pre-warm or Testing

2–30 °C 2–8 °C 2–30 °C 2–8 °C -20 °C

Urine 4 hours 24 hours 5 days 30 days

Vaginal/Endocervical Swab Collected for

BD MAX CT/GC/TV or BD MAX CT/GC assays (requiring pre-warm) 2 hours 5 days 30 days

Vaginal Swab Collected for BD MAX Vaginal Panel

(not requiring pre-warm) 2 hours 8 days 14 days


PRECAUTIONS:


• If the BD MAX UVE Specimen Collection Kit is used for self-collected vaginal swab specimens, the patient should only be provided with the BD MAX UVE Specimen Collection Swab. Transfer into the BD MAX UVE Sample Buffer Tube should be performed by qualified personnel.

• The BD MAX CT/GC/TV and BD MAX CT/GC assays have been tested with self-collected vaginal specimens. Vaginal swabs, other than the BD MAX Specimen Collection Swab, have not been evaluated with the BD MAX CT/GC/TV and BD MAX CT/GC assays.

• The collection of vaginal swab specimens from asymptomatic patients with the BD MAX UVE Specimen Collection Kit for use with the BD MAX Vaginal Panel has not been evaluated.

• Do not pre-warm samples to be tested with the BD MAX Vaginal Panel.

• Do not freeze specimens to be tested with the BD MAX Vaginal Panel.

• Do not pre-wet the swab with the BD MAX UVE Sample Buffer prior to collection.

• Do not use expired reagents and/or materials.

• Do not use swabs if the sheaths are open or broken.

• Optimal performance of the BD MAX assays requires proper specimen collection, handling and transport.

• Always handle specimens as if they are infectious and in accordance with safe laboratory procedures such as those described in CLSI Document M291 and in Biosafety in Microbiological and Biomedical Laboratories.2

• Proper labeling should accompany each specimen to the laboratory.

• Take care when handling specimens to avoid cross-contamination. Specimens can contain high levels of organisms. If gloves come into contact with the specimen, change them immediately to avoid contamination.

• When breaking the shaft of the swab, take care to avoid splashing of the contents or contamination of the BD MAX UVE Sample Buffer Tube.

• Wear protective clothing and disposable gloves while handling all reagents.

• Do not pipette by mouth.

• Do not smoke, drink, chew or eat in areas where specimens or kit reagents are being handled.

• Dispose of unused reagents and waste in accordance with local, state, provincial, and/or federal regulations.

• Sample collection is a critical step for obtaining reliable assay results. Following the specimen collection instructions accurately is key to assay performance. Personnel collecting specimens for transport with this system should be trained on these instructions.


LIMITATIONS OF THE PROCEDURE

Lubricants or other products containing substances such as carbomers, can increase the non-reportable rate obtained with BD MAX Vaginal Panel and BD MAX CT/GC/TV or BD MAX CT/GC assays.




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Fort Lauderdale, Florida

33312

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Fax: (954) 797-9494

Email: lab@infertilitylab.com

Website: www.infertilitylab.com

About Unilab

Unilab is an FDA-registered medical laboratory specializing in infertility and reproductive testing. Unilab is trusted by fertility doctors everywhere to provide accurate and timely results.

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