First To Know Sales Controls Brochure.pdf
PDF 485 KB Posted
- Attached to
- First To Know Syphilis Tests and Controls Sets
- Solicitation number
- QQ-130085
- Issued by
- Henrico County, Roanoke City, Virginia
About this file
This document is a Package Insert and usage brochure for the First To Know Non-assayed Syphilis Control Set, a quality control material manufactured by NOWDiagnostics, Inc. for use with First To Know Syphilis Tests in Virginia. The product consists of one positive control and one negative control, each supplied as 0.5mL plasma samples in dropper bottles, along with ten syphilis test cassette caps. The controls are intended for in vitro diagnostic use to monitor test performance for the detection of syphilis antibodies. The control materials are sourced from plasma donors tested negative for HIV, Hepatitis B, and Hepatitis C, heat inactivated, defibrinated, clarified, and preserved with ProClin 300 to extend shelf life. The materials are supplied ready to use and must be stored refrigerated at 2-8°C, remaining stable until the expiration date on the label and for 30 days after opening when properly maintained.
The brochure provides comprehensive instructions for performing quality control testing with both positive and negative controls, requiring users to warm materials to room temperature before use, apply one drop of control to the sample application point, and observe results after a 15-minute incubation period. Storage and disposal must comply with state and local regulations for biological materials, and the product includes a catalog number (457.012) for ordering purposes. The package insert directs users to NOWDiagnostics, Inc., located in Springdale, Arkansas, for inquiries, ordering assistance, and customer support via phone, email, and website resources.
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Other files
| File | Type | Posted |
|---|---|---|
| First To Know Sales Tests Brochure.pdf | ||
| Quick Quote Template Syphilis Tests.docx | DOCX document |
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Text version
Read this Package Insert completely before using the control set.
Follow the instructions carefully when performing quality control of the test. Failure to follow instructions may result in inaccurate quality control results.
The First To Know® Non-assayed Syphilis Control Set is intended for in vitro diagnostic use with the First To Know® Syphilis Test as non-assayed control material to monitor test performance for the detection of syphilis antibodies.
First To Know® Syphilis Non-assayed Negative Controls are sourced from syphilis negative plasma donors. First To Know® Syphilis Non-assayed Positive Controls are prepared by spiking syphilis antibody positive plasma into syphilis antibody negative plasma. All plasma samples have been heat inactivated, defibrinated, and clarified. A low concentration of ProClin™ 300 preservative has been added to the plasma controls to extend their shelf life by effectively inhibiting a broad spectrum of microbes. Both controls are plasma samples, a typical patient sample used for syphilis antibody test performance. The controls are supplied ready to use in dropper bottles.
Store the First To Know® Non-assayed Syphilis Control Set refrigerated at 2-8'C (36-46'F). The set is stable until the expiration date shown on the label.
Do NOT Freeze.
Controls are stable for 30 days after first opening when stored at +2'C to +8'C between each use. Record Date Opened and record +30 Days Expiration Date on the bottle.
Allow to warm to room temperature before use in the test.
Refrigerate after use.
Refer to state and local regulations for handling and disposal of positive and negative controls.
Pl-457.012.indd 1
MATERIALS PROVIDED:
One (1) First To Know® Syphilis Non-assayed Positive Control (0.5ml)* One (1) First To Know® Syphilis Non-assayed Negative Control (0.5mL)* Ten (10) First To Know® Syphilis Test Cassette Caps One (1) Package Insert
MATERIALS REQUIRED BUT NOT PROVIDED:
Gloves Refrigerator Watch or timer First To Know® Syphilis Test and Package Insert
*Contains 0.1% ProC/in 300
For in vitro Diagnostic Use.
Read this Package Insert completely before using the First To Know®
Non-assayed Syphilis Control Set.
Do not use control beyond the expiration date shown on the label.
Use disposable gloves while you perform the test.
Used tests and other associated materials should be discarded into appropriate waste containers.
Allow controls to come to room temperature before use.
Use the amount of control as described in the Package Insert (i.e. one drop). Using an excess amount may result in a false result.
Plasma sourced from human plasma donors who tested negative for HIV, Hepatitis B, and Hepatitis C.
Follow universal precautions. Contains material of human origin. Handle as a potential carrier and transmitter of disease.
Quality control materials should be used in accordance with local, state, and/or federal regulations or accreditation requirements.
Do not use controls beyond the expiration date on the label.
10/3/25 10:52AM I
Remove the First To Know®
Non-assayed Control Set from the refrigerator prior to use.
Allow the control set to warm to room temperature before use.
Read the Package Insert for the First To Know® Syphilis Test for more information.
Record Date Opened and record +30 Days Expiration Date on the bottle.
POSITIVE CONTROL
1. Remove the Cassette from the foil pouch carefully. Place the Cassette and the Cassette Cap on a flat surface. Attach the Cassette Cap to the end of the Sample Application Zone by aligning it properly and snapping it into place.
2. Mix the Control vigorously for at least 5 seconds.
3. Add one drop of Positive Control to the Sample Application Point of the Cassette which is equivalent to 50µL of sample.
4. Once the Sample Application Zone is full, tap the Test on the table firmly twice with the capped end facing up. Lay the Test on a flat surface.
5. Start the timer for 15 minutes.
6. After 15 minutes, observe the appearance of the bands in the Test Window at the Control Position (C) and the Test position (T). See Interpretation of Results in the First to Know® Syphilis Test Package Insert.
c n � Control (C) Line T � Test (T) Line
Know·
Fill Line
Fill Zone Sample Application Zone
-- Cassette Cap
NEGATIVE CONTROL
1. Remove the Cassette from the foil pouch carefully. Place the Cassette and the Cassette Cap on a flat surface. Attach the Cassette Cap to the end of the Sample Application Zone by aligning it properly and snapping it into place.
2. Mix the Control vigorously for at least 5 seconds.
3. Add one drop of Negative Control to the Sample Application Point of the Cassette which is equivalent to 50µL of sample.
4. Once the Sample Application Zone is full, tap the Test on the table firmly twice with the capped end facing up. Lay the Test on a flat surface.
5. Start the timer for 15 minutes.
6. After 15 minutes, observe the appearance of the bands in the Test Window at the Control Position (C) and the Test position (T). See Interpretation of Results in the First to Know® Syphilis Test Package Insert.
.. NOWDiagnostics, Inc .
1200 Stewart Place Springdale, AR 72764
Phone: 1-844-207-3370
Pl-457.012.indd 2
Email: consumercare@nowdx.com Website: www.firsttoknow.com
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For inquiries, visit the First To Know® website at firsttoknow.com.
To view this Package Insert in Spanish, visit firsttoknow.com.
For ordering assistance, contact your local sales representative or NOWDiagnostics at orders@nowdx.com.
Item: First To Know® Syphilis Convenience Kit
Item: First To Know® Non-assayed Syphilis Control Set
Catalog Number: 8057-25-CP
Catalog Number: 457.012
� Use by or Expiration Date -t Storage Temperature
� Catalog Number or Product Code [§] Lot Number
.. Manufacturer & Caution
CE] Consult Instructions for Use � Control
10/3/25 10:52AM I
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