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ELISA Kit for testing

LaylarueLaylarue member
in Trouble TTC

Hi ladies!  Sorry I haven't been around much lately, but I miss you all!  I  have a quick question.  I requested all my blood work from that 2nd opinion RE I went to and I just got them back today.  Under several different result sections there is a note that says this exactly:

 *This test was performed using ELISA kit that has not been cleared or approved by the FDA.  The analytical performance characteristerics of this test has been determined by the PathGroup Labs.  This test should not be used for diagnosis without confirmation by other medically established means.  Values obtained with different kit methods cannot be used interchangeably.  

 Have any of you heard of ELISA?  If it's not approved for diagnosing why would a major IF clinic in my city use that?  I'm just so confused because there are some major changes on there from my first batch of bloodwork with my current RE that was done last July.  It's concerning to me, but I don't want to go back to this RE for an explanation because I have no intentions of ever stepping foot in that place again.  

 Sorry this was so long.  TIA!!! 

My Chart My Blog




After almost 2 years of TTC and fertility treatments we got a surprise BFP in May 2013
1/14/14 Baby Boy!! 
TTC for #2 October 2015

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Re: ELISA Kit for testing

  • girlgamer07girlgamer07 member

    Hi!

    I work in a laboratory performing laboratory testing and might be able to give you some insight. What exactly were the tests that you were having done?

    ELISA stands for Enzyme Linked Immunosorbant Assay and is a very common methodology

    TTC since 1/2011
    DH 32 SA Only 3% Normal Forms, but good count good motility
    Me 32 DOR FSH 11.3, AFC 7, HSG normal
    5/28/13- IUI #1 50 mg Clomid BFN
    6/25/13 IUI #2 50 mg Clomid BFN
    7/27/13 IUI#3 50 mg Clomid BFN
    8/8/13 waiting to meet with the RE to discus IVF
    11/9/2013 IVF#1 canceled, only 1 follicle  :(
    12/26/2013 Starting Lupron for IVF#2
    1/21/2014 Retrieval but we still only had 1 follicle so only 1 egg. Fingers Crossed!!!
    2/5/2014 BFP!! Betas 39, 54, 217, 1681 Slow rising but this is the little egg that could :)
    2/19/2014 1st U/S at 6w1d showed us at 5w4d but yolk sac, gest. sac and the beginnings of a fetal pole identified. 
    2/26/2014 2nd U/S at 7w1d showed us at 6w4d and we saw a heartbeat!!! 133. RE says it's time to move to OB
    So far everything is looking good :)
    5/29/2014 It's a Girl!!!! :)
    7/6/2014 Failed my glucose tolerance tests, diabetic diet it is
    9/30/2014 Scheduled C-Section for Placenta Previa and she's perfect 

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  • LaylarueLaylarue member

    Basically I had all the initial blood work done again. CD3 bw and then the lupron challenge test.  I guess the main thing standing out to me right now is that last July my AMH level was 6.6 (I'm not sure which type of test that was done with), now

    My Chart My Blog




    After almost 2 years of TTC and fertility treatments we got a surprise BFP in May 2013
    1/14/14 Baby Boy!! 
    TTC for #2 October 2015

    Report Reply
  • girlgamer07girlgamer07 member

    Thank you for the additional information. First off to put your mind at ease, just because a test hasn?t been approved by the FDA does not mean it can?t be used to monitor/treat/advise patients. The regulatory proces

    TTC since 1/2011
    DH 32 SA Only 3% Normal Forms, but good count good motility
    Me 32 DOR FSH 11.3, AFC 7, HSG normal
    5/28/13- IUI #1 50 mg Clomid BFN
    6/25/13 IUI #2 50 mg Clomid BFN
    7/27/13 IUI#3 50 mg Clomid BFN
    8/8/13 waiting to meet with the RE to discus IVF
    11/9/2013 IVF#1 canceled, only 1 follicle  :(
    12/26/2013 Starting Lupron for IVF#2
    1/21/2014 Retrieval but we still only had 1 follicle so only 1 egg. Fingers Crossed!!!
    2/5/2014 BFP!! Betas 39, 54, 217, 1681 Slow rising but this is the little egg that could :)
    2/19/2014 1st U/S at 6w1d showed us at 5w4d but yolk sac, gest. sac and the beginnings of a fetal pole identified. 
    2/26/2014 2nd U/S at 7w1d showed us at 6w4d and we saw a heartbeat!!! 133. RE says it's time to move to OB
    So far everything is looking good :)
    5/29/2014 It's a Girl!!!! :)
    7/6/2014 Failed my glucose tolerance tests, diabetic diet it is
    9/30/2014 Scheduled C-Section for Placenta Previa and she's perfect 

    imageimage image
    image
    Baby Birthday Ticker Ticker
    Report Reply
  • LaylarueLaylarue member
    Thank you so much for that! It does make me feel a lot better!  I really do appreciate it. 
    My Chart My Blog




    After almost 2 years of TTC and fertility treatments we got a surprise BFP in May 2013
    1/14/14 Baby Boy!! 
    TTC for #2 October 2015

    Report Reply
  • girlgamer07girlgamer07 member
    Absolutely anytime! It's what I do for a living and can be very confusing 
    TTC since 1/2011
    DH 32 SA Only 3% Normal Forms, but good count good motility
    Me 32 DOR FSH 11.3, AFC 7, HSG normal
    5/28/13- IUI #1 50 mg Clomid BFN
    6/25/13 IUI #2 50 mg Clomid BFN
    7/27/13 IUI#3 50 mg Clomid BFN
    8/8/13 waiting to meet with the RE to discus IVF
    11/9/2013 IVF#1 canceled, only 1 follicle  :(
    12/26/2013 Starting Lupron for IVF#2
    1/21/2014 Retrieval but we still only had 1 follicle so only 1 egg. Fingers Crossed!!!
    2/5/2014 BFP!! Betas 39, 54, 217, 1681 Slow rising but this is the little egg that could :)
    2/19/2014 1st U/S at 6w1d showed us at 5w4d but yolk sac, gest. sac and the beginnings of a fetal pole identified. 
    2/26/2014 2nd U/S at 7w1d showed us at 6w4d and we saw a heartbeat!!! 133. RE says it's time to move to OB
    So far everything is looking good :)
    5/29/2014 It's a Girl!!!! :)
    7/6/2014 Failed my glucose tolerance tests, diabetic diet it is
    9/30/2014 Scheduled C-Section for Placenta Previa and she's perfect 

    imageimage image
    image
    Baby Birthday Ticker Ticker
    Report Reply
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